UNESCO and WHO Launch Initiative to Promote Healthier School Environments 22/06/2021 Chandre Prince A new initiative by UNESCO and WHO aims to promote healthier school environments for all learners. A new initiative by the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the World Health Organization(WHO) on Tuesday aims to help countries to promote healthier school environments – including nutritious school lunches, opportunities for more physical activity, and mental health support – for 1.9 billion school-aged children and adolescents worldwide. An estimated 365 million primary school children have globally suffered from hunger and increased rates of stress, anxiety and other mental health issues due to school closures during the COVID-19 pandemic, according to WHO, which announced the joint initiative today. The Global Standards for Health-promoting Schools resource package includes eight “health promoting schools” standards developed to ensure all schools promote life skills, cognitive and socio emotional skills and healthy lifestyles for all learners. “Schools play a vital role in the well-being of students, families and their communities, and the link between education and health has never been more evident,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in the announcement of the new initiative. The new standards cover school and government policies and resources, school governance, leadership and community partnerships, a curriculum that supports health and wellbeing such as nutrition and safety, a social-emotional environment fostering equity and diversity and delivering school-linked health services. The global standards will be piloted in Botswana, Egypt, Ethiopia, Kenya and Paraguay. “These newly launched global standards are designed to create schools that nurture education and health, and that equip students with the knowledge and skills for their future health and well-being, employability and life prospects,” said Dr Tedros. UNESCO Director-General Audre Azouley said schools that do not promote healthy lifestyles, is “no longer justifiable and acceptable”. “Education and health are interdependent basic human rights for all, at the core of any human right, and essential to social and economic development,” said Azouley. COVID-19 resulted in emotional distress and mental health of school children Overview of the health-promoting school implementation cycle According to the two global bodies, comprehensive health and nutrition programmes in schools have significant impacts among school-aged children. Examples include Malaria prevention interventions resulting in a 62% reduction in absenteeism; provision of school meals increasing enrolment rates by 9% on average, and attendance by 8%; how free screening and eyeglasses have led to a 5% higher probability of students passing standardised tests in reading and mathematics. Another example is how comprehensive sexuality education encourages the adoption of healthier behaviours, promotes sexual and reproductive health and rights, and improves sexual and reproductive health outcomes such as the reduction of HIV infection and adolescent pregnancy rates. Professor Susan Sawyer, one of the researchers at the Centre for Adolescent Health at the Murdoch Children’s Research Institute who led the two-year project at the invitation of UNESCO and WHO, in a statement said links between children’s health, wellbeing and learning have been demonstrated through the impact of COVID-19 on school closures. “In addition to the disruptive effects on student engagement, learning outcomes and educational transitions, there is growing global evidence of the impact of school lockdowns on children’s and adolescents’ emotional distress and mental health,” she said. “There are concerns that students with major mental health disorders are at greater risk of permanently disengaging from education. While negatively affecting their future career prospects, early school leaving becomes a risk factor for poor health in adulthood. The global standards contribute to WHO’s 13th General Program of Work target of ‘1 billion lives made healthier’ by 2023 and the global Education 2030 Agenda coordinated by UNESCO. It was first articulated by WHO, UNESCO and UNICEF in 1995 and adopted in over 90 countries and territories. “However, few countries have implemented it at scale, and even fewer have effectively adapted their education systems to include health promotion,” said WHO in a statement. Image Credits: Commons Wikimedia, WHO. WHO Formally Declares End of Guinea’s Second Ebola Outbreak 22/06/2021 Editorial team The World Health Organization formally declared an end to Guinea’s second Ebola outbreak. The Ebola outbreak in Guinea which claimed 12 lives and infected 12 people has officially been declared over, more than four months after the deadly virus broke out in the West African country. Guinean health authorities declared the outbreak on 14 February 2021 after three cases were detected in Gouecke, a rural community in the southern N’zerekore prefecture, the same region where the 2014–2016 outbreak first emerged before spreading into neighbouring Liberia and Sierra Leone and beyond. “I commend the affected communities, the government and people of Guinea, health workers, partners and everyone else whose dedicated efforts made it possible to contain this Ebola outbreak,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General on Saturday. “Based on the lessons learned from the 2014–16 outbreak and through rapid, coordinated response efforts, community engagement, effective public health measures and the equitable use of vaccines, Guinea managed to control the outbreak and prevent its spread beyond its borders. Our work in Guinea continues, including supporting survivors to access post-illness care.” A total of 16 confirmed and seven probable cases were reported in Guinea’s latest outbreak in which 11 patients survived and 12 lives lost. Shortly after the infections were detected, national health authorities, with support from WHO and partners, mounted a swift response, tapping into the expertise gained in fighting recent outbreaks both in Guinea and in the Democratic Republic of the Congo. Read more here… Image Credits: WHO AFRO. Forty New Medicines & 16 New Indications Under Consideration For WHO Essential Medicines List 21/06/2021 Elaine Ruth Fletcher Six new cancer treatments for children are among the draft recommendations for this year’s update of the WHO Essential Medicines List. Proposals to incorporate some 40 new medications in WHO’s Essential Medicines List – from complex cancer treatments to new medicines for hepatitis C and rabies – will be examined over the coming two weeks by the EML Expert Committee. The Committee, which kicked off its deliberations on Monday with a public hearing, also will consider revised or amended recommendations on some 16 treatment indications. Those include recommendations to incorporate new childhood medicines for treatment of cancer, antibiotics for use in neonatal meningitis and intra-abdominal infections. But there is also a recommendation against the use of antibiotics in most cases of acute bronchitis among healthy people – one of a number measures under consideration as part of the progressive WHO drive to make more rational use of antibiotics and fight antimicrobial resistance. Strikingly, COVID drugs are one issue not on the EML agenda, said Benedikt Huttner, Secretary of the Expert Committee, at the outset of the public session. Rather, a separate WHO process is being devoted to the consideration of guidelines on essential COVID treatments – although certain COVID diagnostics are being considered by the EML expert group for inclusion in a related Essential Diagnostics List (EDL). Monday’s wide-ranging public session saw detailed presentations by two dozen experts and civil society groups on issues ranging from the highly technical to the politics of medicines access – with the two often deeply intertwined. The EML is used as a baseline reference point for national governments and insurance providers in considering medicines to prioritize in health systems and services. Final recommendations from the Committee for 2021 updates to the EML are expected in August. Expanding Antibiotic Use – while Fighting Antibiotic Resistance Mike Sharland, chair of the EML Working Group on Antibiotics, presents vision on fighting AMR while expanding essential medicines use Mike Sharland, chair of the EML Working Group on Antibiotics focused on the delicate choices facing the committee in terms of ensuring access to essential antibiotics – while rationalizing use to stem the tide of drug resistant pathogens – also known as antimicrobial resistance (AMR). A key WHO aim is to ensure wider access to the most basic life-saving antibiotics in parts of the world where vital drugs may not be widely available – while reserving certain classes of antibiotics for treating more resistant bacterial infections, said Mike Sharland, Chair of the EML Antibiotics Working Group, and a professor at St. George’s University of London. Those more sensitive drugs are typically “broad spectrum” antibiotics that are on special WHO “Watch” and “Reserve” lists, which indicates that they should be used in only specific, limited indications or when all other treatments have failed. In contrast, antibiotics listed on the WHO’s “Access” list can and should be used more widely for common bacterial infections. The three-tiered system, known as “AWaRe” was developed by WHO in 2017. Said Sharland, the group’s draft recommendations would fine-tune EML guidance so that “for most common primary fare infections, sore throats, ear infections, sinusitis, simple infections…can be treated by ‘Access’ antibiotics.:” This is in contrast to the global trends towards use of stronger antibiotics in the primary health care sector, he said noting a “a doubling in the use of broad spectrum or “Watch” antibiotics in the primary care sector, in recent years. While inappropriate antibiotic use cuts across high- and low- or middle-income countries, it tends to be more prevalent in LMICS, he noted. There is indiscriminate use of antibiotics in both high- and low-income settings – although use of non-recommended antbiotics to inappropriately treat certain conditions is higher in LMICs as compared to HICs. This year’s recommendations include provisions that the Essential Medicines List recommendations can be used to discourage inappropriate antibiotic use for many forms of “milder” illness among patients who are “not ill with underlying disease”, he added. This, in line with the WHO goal that some 60% of antibiotics used at country level by 2023 should belong to the WHO “Access” group. One new draft EML recommendation under consideration would nix the use of antibiotics at all for acute bronchitis among otherwise healthy children – unless there is “clear evidence for, or a strong suspicion of a secondary bacterial infection.” This, as Sharland said, comes as part of a wider effort by the EML to “think about… whether it’s clinically appropriate” to recommend antibiotics at all for some conditions. The Dilemma of Cancer Medicines – Effective but Expensive Elisabeth de Vries presents on the higher rates of mortality in low- and middle income countries due to lack of access to treatment – at the WHO Essential Medicines List committee’s public session Monday, 21 June. This year’s EML expert group had received proposals for the inclusion of 16 new cancer drugs as well as 6 new indications in the EML basket, said Elisabeth de Vries, chair of the WHO EML Working Group on Cancer Medicines, Notably, six of the 23 submissions were for children’s cancer drugs. A key concern of the committee in this year’s expert reviews has been the affordability of many of the new cancer treatments – in which newer and more effective treatments are often be far beyond the range of many low- and middle-income countries to pay, said De Vries, who also chairs the cancer medicines committee of the European Society of Medical Oncology. This, she noted, comes against a landscape in which the number of new cancer patients is expected to increase from 19.3 million to some 30 million by 2040 – and cancer mortality remains significantly higher in low- and middle-income countries of the world. Cancer cases are expected to increase from some 19.3 million annually in 2020 to 30.2 million in 2040. She called out monoclonal antibodies in particular – for which there are now 41 US-FDA approved treatments for cancer indications – as “difficult to produce and they’re very expensive.” “There are many good cancer medicines, and there are more good cancer medicines to come. But unequal access to cancer medicines and high prices of cancer medicines make them currently, often unaffordable,” she said. An increasing number of monoclonal antibodies are being used to treat cancers – despite their high expense Access Advocates Call for New EML Category – ‘Essential but Expensive’ The challenges faced by the EML in recommending new cancer treatments are symptomatic of a broader dilemma, stressed civil society groups in a series of follow-up presentations. And in light of those challenges of efficacy versus cost, the WHO Essential Medicines List, first conceived in the 1970s as a guidance for national governments, needs to be “completely re-evaluated”, contended Knowledge Ecology International’s Kavian Kulasabanathan. “Today the EML often plays a negative role in debates over access to medicines,” said Kulasabanathan. “The low number of patented medications on the EML is frequently cited as demonstrative that patents are not a barrier to global access to essential medicines. It is not surprising that many patients and patient advocates chafe at the paucity of newer drugs on the EML as a result of this policy tension. He called for the creation of a list for drugs that are “medically essential, but face challenges regarding affordability,” reviving a proposal pitched in past years to the EML expert committee, which last met in 2019. “KEI’s position is that the earlier framework for the EML needs to be completely re-evaluated, to take into account changes in the health infrastructure worldwide, the disparity of resources between developing countries, scientific progress, and new global norms to “promote access to medicines for all….. “”The WHO Expert Committee has been asked, several times, to create a category in the EML for products that would be essential, if available at affordable prices. A pathway for affordable antineoplastics would expand treatment options for patients, including the inclusion of second-line treatments…. “If drugs are medically effective, but expensive, they should be placed in an EML category for drugs that are medically essential but face challenges regarding affordability. Governments and patients would take this as a signal to implement policies to make these medically effective therapies affordable. A system of WHO guidance that consistently ignores or excludes new drugs for cancer needs to be reformed, and new options for dealing with affordability and access are needed if we are serious about achieving equality of health outcomes.” Identify Promising Treatments Earlier On – MPP Another way tht the EML could use its leverage would be to identify promising new treatments earlier on – and then demanding more detailed data on costs and access which can help drive voluntary deals with manufacturers, added Esteban Burrone, head of policy and advocacy at the Medicines Patents Pool, which negotiates voluntary licenses with industry for the manufacture of vital drugs in low- and middle-income countries. “Over the years, I have repeatedly heard the frustration from members of this Committee or other stakeholders: a medicine gets listed on the WHO EML, but access to that drug continues to be limited in LMICs, causing unacceptable morbidity or mortality. I would like to state that it doesn’t have to be that way. We can plan for future access now,” Burrone said. “If the Committee decides not to list them [a promising drug] for now and asks for further data, will it also make an ask on cost? Will it recommend what needs to happen so that these clinically important medicines can become widely available and cost-effective in LMICs?” he asked, citing the case of the HIV drug dolutegravir – in which MPP, supported by WHO, negotiated a manufacturing license for a generic version only a year after the patented drug was first approved by the FDA. “Will it be forward looking, as WHO was in the case of dolutegravir? If you would like to see affordable generic versions being developed for use in LMICs, you can contribute to making that happen. “You can ask for it and give a mandate to WHO and other stakeholders to make that happen,” he said, adding that MPP stands ready to support such efforts through its voluntary license model – and demonstrated track record with opening up access to lifesaving hepatitis and HIV medicines for millions of people in the developing world. 🎙️MPP's @eburrone is addressing the @WHO Expert Committee on Selection&Use of #EssentialMedicines:✅important to plan for access NOW through early identification of promising new treatments✅MPP is ready to support future access to promising new meds through our licensing model pic.twitter.com/Ml3EzsPTm5 — MedicinesPatentPool (@MedsPatentPool) June 21, 2021 IFPMA Asks EML Experts to Recognize Countries’ Right to Choose On the other side of the fence, Sara Amini of the International Federation for Pharmaceutical Manufacturers and Associations (IFPMA), argued that while the WHO Essential Medicines List can be a “useful tool” guiding drug choices by countries and procurement agencies – it should not be portrayed as the final word on treatment choices by health-care providers. “IFPMA recognizes EML’s value as a foundational list of medicines that meets the priority healthcare needs of health systems and their populations,” Amini stated, “However, such decisions, while guided by EML, should also reflect each nation’s unique health landscape, taking into account national disease burden, health system capacities, and socio-cultural characteristics of the population. “As such, the EML should not be used as an impediment for governments, healthcare professionals or patients to adopt other treatment options, which may not be listed on the EML, but are deemed appropriate at a national level.” Defining Biologically Similar Drugs & Quality Assurance Another issue of concern for industry, Amini added, remains the WHO’s recommendations for the use of “biosimilar” versions of patented biological medicine treatments – often seen in the cancer arena as well as in other noncommunicable disease treatments. She said that the EML expert group should develop more refined terms of reference to such drugs in the EML context, including more precise definitions of what constitutes biologically equivalent drug formulations of certain biologically-based medications. EML recommendations for leading anti-cancer drugs, or their biosimilars, such as rituximab (RituxanⓇ) and trastuzumab (HerceptinⓇ) should also contain better definitions as to what constitutes a “quality-assured biosimilar”, she contended. Those definitions, Amini said, would be made in line with “WHO’s commitment to supporting globally acceptable principles for licensing biological products that are claimed to be similar to biological products of assured quality, safety, and efficacy on the basis of proven similarity.” Image Credits: WHO, Mike Sharland , Presentation by Mike Sharland, chair of the EML Working Group on Antibiotics . Ugandan Drug Authority Urges Maker of Popular COVID-19 Herbal Remedy to Conduct Clinical Trial 21/06/2021 Esther Nakkazi KAMPALA – As Uganda battles its worst COVID-19 outbreak, the government has called on a researcher who is selling a herbal remedy to treat COVID-19 to provide clinical proof that it works. Professor Patrick Engeu Ogwang is a renowned researcher in herbal medicines, head of pharmacy at Mbarara University of Science and Technology (MUST) and a former executive member of the Pharmaceutical Society of Uganda. He is also the founder of the herbal remedy which is being marketed as Covidex, a COVID-19 treatment although there is no proof that it works. The government has said it is willing to provide financial support to Ogwang to enable Covidex to go through proper clinical trials but that he should present scientific evidence of its efficacy and safety before marketing it as a treatment for the virus. “He is a very good researcher. We know him very well but he did this particular work alone. He has not shared it with anyone,” said Dr Monica Musenero, the Presidential Advisor on Epidemics and COVID-19. “We want to work with him and we are waiting for him to bring evidence. We are even willing to provide him with funding and even patients so that other people other than him tell us if the drug works and is safe,” she added. With the current second wave of the pandemic and a steep rise in COVID-19 cases, the government says people are desperate and they have a duty to protect the public. “All we see is information on social media of pictures of people lining up to buy the drug. We are not saying that the vaccine is bad or it does not work or is harmful. We just need evidence. Science is designed in a way that no single individual can claim that something works without convincing a panel of other people,” said Musenero. “The drug has not gone through clinical trials and as a person working with the World Health Organisation (WHO) I cannot make any more comments about it,” said WHO vaccines medical officer Dr Phiona Atuhebwe. “We all know what happened in Madagascar and Tanzania.” Dr Ambrose Talisuna, WHO Africa’s team leader on emergency preparedness, said that the remedy must undergo rigorous testing before being rolled out on the market. “People are gullible in a situation like this where there is a pandemic. My recommendation is for the Professor to take his drug through rigorous testing,” said Talisuna. Meanwhile, the Pharmaceutical Society of Uganda (PSU) has applauded Ogwang’s efforts to develop Covidex “considering that no proven cure for the pandemic has yet been established globally”. The PSU says it will stand by Ogwang and has already put in place a taskforce to provide him with technical support to develop Covidex in compliance with the established guidelines for research and development of herbal medicines. The PSU also said that it is engaging with Uganda’s drug regulatory body, the National Drug Authority (NDA), to ensure support for Ogwang. No Approval Given for Covidex, says NDA However, the NDA warned the public against using Covidex: “Uganda Drug Authority (NDA) has learnt with concern the promotion and sale of Covidex manufactured by Jena Herbals (U) Ltd that claims to prevent and treat COVID-19.” “NDA informs the public that it has not undertaken any assessment or approved Covidex, nor has it received any application from the innovator of the Covidex as required by National Drug Policy and Act cap 206,” said the NDA’s public relations manager, Abiaz Rwamwiri. The NDA has authorized a number of products from Jena Herbals, including an anti-malaria product, and notes that the company is aware of the process required for clinical trials, authorization, drug promotion and licensing before production and sale of herbal medicine. The NDA confirmed that it had met a team from Jena Herbals led by Ogwang and it had agreed to follow these necessary processes. After the meeting, Ogwang issued a statement saying that more proof was needed that Covidex worked to relieve the symptoms of COVID-19, and that the agency had advised him ti change the product;s name so it could not be associated with COVID-19. Ogwang told Health Policy Watch that his team was busy writing the clinical trial protocol which will be presented to the government. Earlier in this week there was a rush to buy Covidex and social media exchanges heightened after the statements from the government said it wanted scientific evidence. Covidex costs about UGX3,000 ($0.8) a unit pack, while a seven-day supply is UGX 21,000 ($6). South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub – WHO Asks Big Pharma to Support Scaleup 21/06/2021 Kerry Cullinan Afrigen is the lead partner in the South African mRNA hub Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday. But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan. WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed. If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday. South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity. “We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing. The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control. Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus. “In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros. Timelines Depend on Big Pharma Support WHO Chief Scientist Soumya Swaminathan If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. “The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan. “There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.” Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. French Welcome Hub to ‘Respond to Variants’ The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”. The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions. However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”. The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. “Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO. “Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.” WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears World Trade Organization Director-General Ngozi Okonjo-Iweala Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”. Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. “We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala. “At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added. She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda. “Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added. “In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.” The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient, shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.” South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. “Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi. He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians – and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production. Image Credits: Afrigen. Technical Fixes or Sweeping Reform? Europe and Developing Countries Face Uphill Battle to Etch Consensus on IP Waiver 18/06/2021 Elaine Ruth Fletcher Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines. Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”. But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June. That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks. #TRIPS Council of #WTO to hold series of meetings till July-end on patent waiver proposal #TRIPSwaiver https://t.co/ImqkiTd4dU via @timesofindia — Alicia Nicholls (@LicyLaw) June 17, 2021 European Union – More ‘Targeted’ Approach The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by: Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license; Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license; Reducing now complex requirements around detailed notification to the WTO of products being exported and where – which can delay their implementation; The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic – precluding the need for a blanket IP waiver. Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. South African and Indian Delegations – Discuss Scope of Waiver and Products Covered At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed. Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic. The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said. READ: 3 reasons why the EU´s #TRIPSWaiver counter-proposal is an insufficient solution in a pandemic #COVID19 💊🔬💉⬇️ https://t.co/4yO2zv6Imt pic.twitter.com/o4kQC55fCL — MSF Access Campaign (@MSF_access) June 18, 2021 And despite the streamlining of compulsory license rules that the EU has proposed, MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” “Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.” United States: Focus On Common Objectives The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached. US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus. The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests. The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal. The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods? Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry. “The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. “Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” Image Credits: Shutterstock. Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WHO Formally Declares End of Guinea’s Second Ebola Outbreak 22/06/2021 Editorial team The World Health Organization formally declared an end to Guinea’s second Ebola outbreak. The Ebola outbreak in Guinea which claimed 12 lives and infected 12 people has officially been declared over, more than four months after the deadly virus broke out in the West African country. Guinean health authorities declared the outbreak on 14 February 2021 after three cases were detected in Gouecke, a rural community in the southern N’zerekore prefecture, the same region where the 2014–2016 outbreak first emerged before spreading into neighbouring Liberia and Sierra Leone and beyond. “I commend the affected communities, the government and people of Guinea, health workers, partners and everyone else whose dedicated efforts made it possible to contain this Ebola outbreak,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General on Saturday. “Based on the lessons learned from the 2014–16 outbreak and through rapid, coordinated response efforts, community engagement, effective public health measures and the equitable use of vaccines, Guinea managed to control the outbreak and prevent its spread beyond its borders. Our work in Guinea continues, including supporting survivors to access post-illness care.” A total of 16 confirmed and seven probable cases were reported in Guinea’s latest outbreak in which 11 patients survived and 12 lives lost. Shortly after the infections were detected, national health authorities, with support from WHO and partners, mounted a swift response, tapping into the expertise gained in fighting recent outbreaks both in Guinea and in the Democratic Republic of the Congo. Read more here… Image Credits: WHO AFRO. Forty New Medicines & 16 New Indications Under Consideration For WHO Essential Medicines List 21/06/2021 Elaine Ruth Fletcher Six new cancer treatments for children are among the draft recommendations for this year’s update of the WHO Essential Medicines List. Proposals to incorporate some 40 new medications in WHO’s Essential Medicines List – from complex cancer treatments to new medicines for hepatitis C and rabies – will be examined over the coming two weeks by the EML Expert Committee. The Committee, which kicked off its deliberations on Monday with a public hearing, also will consider revised or amended recommendations on some 16 treatment indications. Those include recommendations to incorporate new childhood medicines for treatment of cancer, antibiotics for use in neonatal meningitis and intra-abdominal infections. But there is also a recommendation against the use of antibiotics in most cases of acute bronchitis among healthy people – one of a number measures under consideration as part of the progressive WHO drive to make more rational use of antibiotics and fight antimicrobial resistance. Strikingly, COVID drugs are one issue not on the EML agenda, said Benedikt Huttner, Secretary of the Expert Committee, at the outset of the public session. Rather, a separate WHO process is being devoted to the consideration of guidelines on essential COVID treatments – although certain COVID diagnostics are being considered by the EML expert group for inclusion in a related Essential Diagnostics List (EDL). Monday’s wide-ranging public session saw detailed presentations by two dozen experts and civil society groups on issues ranging from the highly technical to the politics of medicines access – with the two often deeply intertwined. The EML is used as a baseline reference point for national governments and insurance providers in considering medicines to prioritize in health systems and services. Final recommendations from the Committee for 2021 updates to the EML are expected in August. Expanding Antibiotic Use – while Fighting Antibiotic Resistance Mike Sharland, chair of the EML Working Group on Antibiotics, presents vision on fighting AMR while expanding essential medicines use Mike Sharland, chair of the EML Working Group on Antibiotics focused on the delicate choices facing the committee in terms of ensuring access to essential antibiotics – while rationalizing use to stem the tide of drug resistant pathogens – also known as antimicrobial resistance (AMR). A key WHO aim is to ensure wider access to the most basic life-saving antibiotics in parts of the world where vital drugs may not be widely available – while reserving certain classes of antibiotics for treating more resistant bacterial infections, said Mike Sharland, Chair of the EML Antibiotics Working Group, and a professor at St. George’s University of London. Those more sensitive drugs are typically “broad spectrum” antibiotics that are on special WHO “Watch” and “Reserve” lists, which indicates that they should be used in only specific, limited indications or when all other treatments have failed. In contrast, antibiotics listed on the WHO’s “Access” list can and should be used more widely for common bacterial infections. The three-tiered system, known as “AWaRe” was developed by WHO in 2017. Said Sharland, the group’s draft recommendations would fine-tune EML guidance so that “for most common primary fare infections, sore throats, ear infections, sinusitis, simple infections…can be treated by ‘Access’ antibiotics.:” This is in contrast to the global trends towards use of stronger antibiotics in the primary health care sector, he said noting a “a doubling in the use of broad spectrum or “Watch” antibiotics in the primary care sector, in recent years. While inappropriate antibiotic use cuts across high- and low- or middle-income countries, it tends to be more prevalent in LMICS, he noted. There is indiscriminate use of antibiotics in both high- and low-income settings – although use of non-recommended antbiotics to inappropriately treat certain conditions is higher in LMICs as compared to HICs. This year’s recommendations include provisions that the Essential Medicines List recommendations can be used to discourage inappropriate antibiotic use for many forms of “milder” illness among patients who are “not ill with underlying disease”, he added. This, in line with the WHO goal that some 60% of antibiotics used at country level by 2023 should belong to the WHO “Access” group. One new draft EML recommendation under consideration would nix the use of antibiotics at all for acute bronchitis among otherwise healthy children – unless there is “clear evidence for, or a strong suspicion of a secondary bacterial infection.” This, as Sharland said, comes as part of a wider effort by the EML to “think about… whether it’s clinically appropriate” to recommend antibiotics at all for some conditions. The Dilemma of Cancer Medicines – Effective but Expensive Elisabeth de Vries presents on the higher rates of mortality in low- and middle income countries due to lack of access to treatment – at the WHO Essential Medicines List committee’s public session Monday, 21 June. This year’s EML expert group had received proposals for the inclusion of 16 new cancer drugs as well as 6 new indications in the EML basket, said Elisabeth de Vries, chair of the WHO EML Working Group on Cancer Medicines, Notably, six of the 23 submissions were for children’s cancer drugs. A key concern of the committee in this year’s expert reviews has been the affordability of many of the new cancer treatments – in which newer and more effective treatments are often be far beyond the range of many low- and middle-income countries to pay, said De Vries, who also chairs the cancer medicines committee of the European Society of Medical Oncology. This, she noted, comes against a landscape in which the number of new cancer patients is expected to increase from 19.3 million to some 30 million by 2040 – and cancer mortality remains significantly higher in low- and middle-income countries of the world. Cancer cases are expected to increase from some 19.3 million annually in 2020 to 30.2 million in 2040. She called out monoclonal antibodies in particular – for which there are now 41 US-FDA approved treatments for cancer indications – as “difficult to produce and they’re very expensive.” “There are many good cancer medicines, and there are more good cancer medicines to come. But unequal access to cancer medicines and high prices of cancer medicines make them currently, often unaffordable,” she said. An increasing number of monoclonal antibodies are being used to treat cancers – despite their high expense Access Advocates Call for New EML Category – ‘Essential but Expensive’ The challenges faced by the EML in recommending new cancer treatments are symptomatic of a broader dilemma, stressed civil society groups in a series of follow-up presentations. And in light of those challenges of efficacy versus cost, the WHO Essential Medicines List, first conceived in the 1970s as a guidance for national governments, needs to be “completely re-evaluated”, contended Knowledge Ecology International’s Kavian Kulasabanathan. “Today the EML often plays a negative role in debates over access to medicines,” said Kulasabanathan. “The low number of patented medications on the EML is frequently cited as demonstrative that patents are not a barrier to global access to essential medicines. It is not surprising that many patients and patient advocates chafe at the paucity of newer drugs on the EML as a result of this policy tension. He called for the creation of a list for drugs that are “medically essential, but face challenges regarding affordability,” reviving a proposal pitched in past years to the EML expert committee, which last met in 2019. “KEI’s position is that the earlier framework for the EML needs to be completely re-evaluated, to take into account changes in the health infrastructure worldwide, the disparity of resources between developing countries, scientific progress, and new global norms to “promote access to medicines for all….. “”The WHO Expert Committee has been asked, several times, to create a category in the EML for products that would be essential, if available at affordable prices. A pathway for affordable antineoplastics would expand treatment options for patients, including the inclusion of second-line treatments…. “If drugs are medically effective, but expensive, they should be placed in an EML category for drugs that are medically essential but face challenges regarding affordability. Governments and patients would take this as a signal to implement policies to make these medically effective therapies affordable. A system of WHO guidance that consistently ignores or excludes new drugs for cancer needs to be reformed, and new options for dealing with affordability and access are needed if we are serious about achieving equality of health outcomes.” Identify Promising Treatments Earlier On – MPP Another way tht the EML could use its leverage would be to identify promising new treatments earlier on – and then demanding more detailed data on costs and access which can help drive voluntary deals with manufacturers, added Esteban Burrone, head of policy and advocacy at the Medicines Patents Pool, which negotiates voluntary licenses with industry for the manufacture of vital drugs in low- and middle-income countries. “Over the years, I have repeatedly heard the frustration from members of this Committee or other stakeholders: a medicine gets listed on the WHO EML, but access to that drug continues to be limited in LMICs, causing unacceptable morbidity or mortality. I would like to state that it doesn’t have to be that way. We can plan for future access now,” Burrone said. “If the Committee decides not to list them [a promising drug] for now and asks for further data, will it also make an ask on cost? Will it recommend what needs to happen so that these clinically important medicines can become widely available and cost-effective in LMICs?” he asked, citing the case of the HIV drug dolutegravir – in which MPP, supported by WHO, negotiated a manufacturing license for a generic version only a year after the patented drug was first approved by the FDA. “Will it be forward looking, as WHO was in the case of dolutegravir? If you would like to see affordable generic versions being developed for use in LMICs, you can contribute to making that happen. “You can ask for it and give a mandate to WHO and other stakeholders to make that happen,” he said, adding that MPP stands ready to support such efforts through its voluntary license model – and demonstrated track record with opening up access to lifesaving hepatitis and HIV medicines for millions of people in the developing world. 🎙️MPP's @eburrone is addressing the @WHO Expert Committee on Selection&Use of #EssentialMedicines:✅important to plan for access NOW through early identification of promising new treatments✅MPP is ready to support future access to promising new meds through our licensing model pic.twitter.com/Ml3EzsPTm5 — MedicinesPatentPool (@MedsPatentPool) June 21, 2021 IFPMA Asks EML Experts to Recognize Countries’ Right to Choose On the other side of the fence, Sara Amini of the International Federation for Pharmaceutical Manufacturers and Associations (IFPMA), argued that while the WHO Essential Medicines List can be a “useful tool” guiding drug choices by countries and procurement agencies – it should not be portrayed as the final word on treatment choices by health-care providers. “IFPMA recognizes EML’s value as a foundational list of medicines that meets the priority healthcare needs of health systems and their populations,” Amini stated, “However, such decisions, while guided by EML, should also reflect each nation’s unique health landscape, taking into account national disease burden, health system capacities, and socio-cultural characteristics of the population. “As such, the EML should not be used as an impediment for governments, healthcare professionals or patients to adopt other treatment options, which may not be listed on the EML, but are deemed appropriate at a national level.” Defining Biologically Similar Drugs & Quality Assurance Another issue of concern for industry, Amini added, remains the WHO’s recommendations for the use of “biosimilar” versions of patented biological medicine treatments – often seen in the cancer arena as well as in other noncommunicable disease treatments. She said that the EML expert group should develop more refined terms of reference to such drugs in the EML context, including more precise definitions of what constitutes biologically equivalent drug formulations of certain biologically-based medications. EML recommendations for leading anti-cancer drugs, or their biosimilars, such as rituximab (RituxanⓇ) and trastuzumab (HerceptinⓇ) should also contain better definitions as to what constitutes a “quality-assured biosimilar”, she contended. Those definitions, Amini said, would be made in line with “WHO’s commitment to supporting globally acceptable principles for licensing biological products that are claimed to be similar to biological products of assured quality, safety, and efficacy on the basis of proven similarity.” Image Credits: WHO, Mike Sharland , Presentation by Mike Sharland, chair of the EML Working Group on Antibiotics . Ugandan Drug Authority Urges Maker of Popular COVID-19 Herbal Remedy to Conduct Clinical Trial 21/06/2021 Esther Nakkazi KAMPALA – As Uganda battles its worst COVID-19 outbreak, the government has called on a researcher who is selling a herbal remedy to treat COVID-19 to provide clinical proof that it works. Professor Patrick Engeu Ogwang is a renowned researcher in herbal medicines, head of pharmacy at Mbarara University of Science and Technology (MUST) and a former executive member of the Pharmaceutical Society of Uganda. He is also the founder of the herbal remedy which is being marketed as Covidex, a COVID-19 treatment although there is no proof that it works. The government has said it is willing to provide financial support to Ogwang to enable Covidex to go through proper clinical trials but that he should present scientific evidence of its efficacy and safety before marketing it as a treatment for the virus. “He is a very good researcher. We know him very well but he did this particular work alone. He has not shared it with anyone,” said Dr Monica Musenero, the Presidential Advisor on Epidemics and COVID-19. “We want to work with him and we are waiting for him to bring evidence. We are even willing to provide him with funding and even patients so that other people other than him tell us if the drug works and is safe,” she added. With the current second wave of the pandemic and a steep rise in COVID-19 cases, the government says people are desperate and they have a duty to protect the public. “All we see is information on social media of pictures of people lining up to buy the drug. We are not saying that the vaccine is bad or it does not work or is harmful. We just need evidence. Science is designed in a way that no single individual can claim that something works without convincing a panel of other people,” said Musenero. “The drug has not gone through clinical trials and as a person working with the World Health Organisation (WHO) I cannot make any more comments about it,” said WHO vaccines medical officer Dr Phiona Atuhebwe. “We all know what happened in Madagascar and Tanzania.” Dr Ambrose Talisuna, WHO Africa’s team leader on emergency preparedness, said that the remedy must undergo rigorous testing before being rolled out on the market. “People are gullible in a situation like this where there is a pandemic. My recommendation is for the Professor to take his drug through rigorous testing,” said Talisuna. Meanwhile, the Pharmaceutical Society of Uganda (PSU) has applauded Ogwang’s efforts to develop Covidex “considering that no proven cure for the pandemic has yet been established globally”. The PSU says it will stand by Ogwang and has already put in place a taskforce to provide him with technical support to develop Covidex in compliance with the established guidelines for research and development of herbal medicines. The PSU also said that it is engaging with Uganda’s drug regulatory body, the National Drug Authority (NDA), to ensure support for Ogwang. No Approval Given for Covidex, says NDA However, the NDA warned the public against using Covidex: “Uganda Drug Authority (NDA) has learnt with concern the promotion and sale of Covidex manufactured by Jena Herbals (U) Ltd that claims to prevent and treat COVID-19.” “NDA informs the public that it has not undertaken any assessment or approved Covidex, nor has it received any application from the innovator of the Covidex as required by National Drug Policy and Act cap 206,” said the NDA’s public relations manager, Abiaz Rwamwiri. The NDA has authorized a number of products from Jena Herbals, including an anti-malaria product, and notes that the company is aware of the process required for clinical trials, authorization, drug promotion and licensing before production and sale of herbal medicine. The NDA confirmed that it had met a team from Jena Herbals led by Ogwang and it had agreed to follow these necessary processes. After the meeting, Ogwang issued a statement saying that more proof was needed that Covidex worked to relieve the symptoms of COVID-19, and that the agency had advised him ti change the product;s name so it could not be associated with COVID-19. Ogwang told Health Policy Watch that his team was busy writing the clinical trial protocol which will be presented to the government. Earlier in this week there was a rush to buy Covidex and social media exchanges heightened after the statements from the government said it wanted scientific evidence. Covidex costs about UGX3,000 ($0.8) a unit pack, while a seven-day supply is UGX 21,000 ($6). South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub – WHO Asks Big Pharma to Support Scaleup 21/06/2021 Kerry Cullinan Afrigen is the lead partner in the South African mRNA hub Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday. But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan. WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed. If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday. South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity. “We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing. The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control. Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus. “In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros. Timelines Depend on Big Pharma Support WHO Chief Scientist Soumya Swaminathan If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. “The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan. “There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.” Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. French Welcome Hub to ‘Respond to Variants’ The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”. The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions. However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”. The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. “Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO. “Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.” WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears World Trade Organization Director-General Ngozi Okonjo-Iweala Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”. Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. “We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala. “At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added. She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda. “Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added. “In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.” The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient, shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.” South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. “Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi. He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians – and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production. Image Credits: Afrigen. Technical Fixes or Sweeping Reform? Europe and Developing Countries Face Uphill Battle to Etch Consensus on IP Waiver 18/06/2021 Elaine Ruth Fletcher Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines. Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”. But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June. That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks. #TRIPS Council of #WTO to hold series of meetings till July-end on patent waiver proposal #TRIPSwaiver https://t.co/ImqkiTd4dU via @timesofindia — Alicia Nicholls (@LicyLaw) June 17, 2021 European Union – More ‘Targeted’ Approach The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by: Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license; Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license; Reducing now complex requirements around detailed notification to the WTO of products being exported and where – which can delay their implementation; The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic – precluding the need for a blanket IP waiver. Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. South African and Indian Delegations – Discuss Scope of Waiver and Products Covered At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed. Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic. The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said. READ: 3 reasons why the EU´s #TRIPSWaiver counter-proposal is an insufficient solution in a pandemic #COVID19 💊🔬💉⬇️ https://t.co/4yO2zv6Imt pic.twitter.com/o4kQC55fCL — MSF Access Campaign (@MSF_access) June 18, 2021 And despite the streamlining of compulsory license rules that the EU has proposed, MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” “Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.” United States: Focus On Common Objectives The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached. US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus. The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests. The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal. The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods? Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry. “The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. “Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” Image Credits: Shutterstock. Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Forty New Medicines & 16 New Indications Under Consideration For WHO Essential Medicines List 21/06/2021 Elaine Ruth Fletcher Six new cancer treatments for children are among the draft recommendations for this year’s update of the WHO Essential Medicines List. Proposals to incorporate some 40 new medications in WHO’s Essential Medicines List – from complex cancer treatments to new medicines for hepatitis C and rabies – will be examined over the coming two weeks by the EML Expert Committee. The Committee, which kicked off its deliberations on Monday with a public hearing, also will consider revised or amended recommendations on some 16 treatment indications. Those include recommendations to incorporate new childhood medicines for treatment of cancer, antibiotics for use in neonatal meningitis and intra-abdominal infections. But there is also a recommendation against the use of antibiotics in most cases of acute bronchitis among healthy people – one of a number measures under consideration as part of the progressive WHO drive to make more rational use of antibiotics and fight antimicrobial resistance. Strikingly, COVID drugs are one issue not on the EML agenda, said Benedikt Huttner, Secretary of the Expert Committee, at the outset of the public session. Rather, a separate WHO process is being devoted to the consideration of guidelines on essential COVID treatments – although certain COVID diagnostics are being considered by the EML expert group for inclusion in a related Essential Diagnostics List (EDL). Monday’s wide-ranging public session saw detailed presentations by two dozen experts and civil society groups on issues ranging from the highly technical to the politics of medicines access – with the two often deeply intertwined. The EML is used as a baseline reference point for national governments and insurance providers in considering medicines to prioritize in health systems and services. Final recommendations from the Committee for 2021 updates to the EML are expected in August. Expanding Antibiotic Use – while Fighting Antibiotic Resistance Mike Sharland, chair of the EML Working Group on Antibiotics, presents vision on fighting AMR while expanding essential medicines use Mike Sharland, chair of the EML Working Group on Antibiotics focused on the delicate choices facing the committee in terms of ensuring access to essential antibiotics – while rationalizing use to stem the tide of drug resistant pathogens – also known as antimicrobial resistance (AMR). A key WHO aim is to ensure wider access to the most basic life-saving antibiotics in parts of the world where vital drugs may not be widely available – while reserving certain classes of antibiotics for treating more resistant bacterial infections, said Mike Sharland, Chair of the EML Antibiotics Working Group, and a professor at St. George’s University of London. Those more sensitive drugs are typically “broad spectrum” antibiotics that are on special WHO “Watch” and “Reserve” lists, which indicates that they should be used in only specific, limited indications or when all other treatments have failed. In contrast, antibiotics listed on the WHO’s “Access” list can and should be used more widely for common bacterial infections. The three-tiered system, known as “AWaRe” was developed by WHO in 2017. Said Sharland, the group’s draft recommendations would fine-tune EML guidance so that “for most common primary fare infections, sore throats, ear infections, sinusitis, simple infections…can be treated by ‘Access’ antibiotics.:” This is in contrast to the global trends towards use of stronger antibiotics in the primary health care sector, he said noting a “a doubling in the use of broad spectrum or “Watch” antibiotics in the primary care sector, in recent years. While inappropriate antibiotic use cuts across high- and low- or middle-income countries, it tends to be more prevalent in LMICS, he noted. There is indiscriminate use of antibiotics in both high- and low-income settings – although use of non-recommended antbiotics to inappropriately treat certain conditions is higher in LMICs as compared to HICs. This year’s recommendations include provisions that the Essential Medicines List recommendations can be used to discourage inappropriate antibiotic use for many forms of “milder” illness among patients who are “not ill with underlying disease”, he added. This, in line with the WHO goal that some 60% of antibiotics used at country level by 2023 should belong to the WHO “Access” group. One new draft EML recommendation under consideration would nix the use of antibiotics at all for acute bronchitis among otherwise healthy children – unless there is “clear evidence for, or a strong suspicion of a secondary bacterial infection.” This, as Sharland said, comes as part of a wider effort by the EML to “think about… whether it’s clinically appropriate” to recommend antibiotics at all for some conditions. The Dilemma of Cancer Medicines – Effective but Expensive Elisabeth de Vries presents on the higher rates of mortality in low- and middle income countries due to lack of access to treatment – at the WHO Essential Medicines List committee’s public session Monday, 21 June. This year’s EML expert group had received proposals for the inclusion of 16 new cancer drugs as well as 6 new indications in the EML basket, said Elisabeth de Vries, chair of the WHO EML Working Group on Cancer Medicines, Notably, six of the 23 submissions were for children’s cancer drugs. A key concern of the committee in this year’s expert reviews has been the affordability of many of the new cancer treatments – in which newer and more effective treatments are often be far beyond the range of many low- and middle-income countries to pay, said De Vries, who also chairs the cancer medicines committee of the European Society of Medical Oncology. This, she noted, comes against a landscape in which the number of new cancer patients is expected to increase from 19.3 million to some 30 million by 2040 – and cancer mortality remains significantly higher in low- and middle-income countries of the world. Cancer cases are expected to increase from some 19.3 million annually in 2020 to 30.2 million in 2040. She called out monoclonal antibodies in particular – for which there are now 41 US-FDA approved treatments for cancer indications – as “difficult to produce and they’re very expensive.” “There are many good cancer medicines, and there are more good cancer medicines to come. But unequal access to cancer medicines and high prices of cancer medicines make them currently, often unaffordable,” she said. An increasing number of monoclonal antibodies are being used to treat cancers – despite their high expense Access Advocates Call for New EML Category – ‘Essential but Expensive’ The challenges faced by the EML in recommending new cancer treatments are symptomatic of a broader dilemma, stressed civil society groups in a series of follow-up presentations. And in light of those challenges of efficacy versus cost, the WHO Essential Medicines List, first conceived in the 1970s as a guidance for national governments, needs to be “completely re-evaluated”, contended Knowledge Ecology International’s Kavian Kulasabanathan. “Today the EML often plays a negative role in debates over access to medicines,” said Kulasabanathan. “The low number of patented medications on the EML is frequently cited as demonstrative that patents are not a barrier to global access to essential medicines. It is not surprising that many patients and patient advocates chafe at the paucity of newer drugs on the EML as a result of this policy tension. He called for the creation of a list for drugs that are “medically essential, but face challenges regarding affordability,” reviving a proposal pitched in past years to the EML expert committee, which last met in 2019. “KEI’s position is that the earlier framework for the EML needs to be completely re-evaluated, to take into account changes in the health infrastructure worldwide, the disparity of resources between developing countries, scientific progress, and new global norms to “promote access to medicines for all….. “”The WHO Expert Committee has been asked, several times, to create a category in the EML for products that would be essential, if available at affordable prices. A pathway for affordable antineoplastics would expand treatment options for patients, including the inclusion of second-line treatments…. “If drugs are medically effective, but expensive, they should be placed in an EML category for drugs that are medically essential but face challenges regarding affordability. Governments and patients would take this as a signal to implement policies to make these medically effective therapies affordable. A system of WHO guidance that consistently ignores or excludes new drugs for cancer needs to be reformed, and new options for dealing with affordability and access are needed if we are serious about achieving equality of health outcomes.” Identify Promising Treatments Earlier On – MPP Another way tht the EML could use its leverage would be to identify promising new treatments earlier on – and then demanding more detailed data on costs and access which can help drive voluntary deals with manufacturers, added Esteban Burrone, head of policy and advocacy at the Medicines Patents Pool, which negotiates voluntary licenses with industry for the manufacture of vital drugs in low- and middle-income countries. “Over the years, I have repeatedly heard the frustration from members of this Committee or other stakeholders: a medicine gets listed on the WHO EML, but access to that drug continues to be limited in LMICs, causing unacceptable morbidity or mortality. I would like to state that it doesn’t have to be that way. We can plan for future access now,” Burrone said. “If the Committee decides not to list them [a promising drug] for now and asks for further data, will it also make an ask on cost? Will it recommend what needs to happen so that these clinically important medicines can become widely available and cost-effective in LMICs?” he asked, citing the case of the HIV drug dolutegravir – in which MPP, supported by WHO, negotiated a manufacturing license for a generic version only a year after the patented drug was first approved by the FDA. “Will it be forward looking, as WHO was in the case of dolutegravir? If you would like to see affordable generic versions being developed for use in LMICs, you can contribute to making that happen. “You can ask for it and give a mandate to WHO and other stakeholders to make that happen,” he said, adding that MPP stands ready to support such efforts through its voluntary license model – and demonstrated track record with opening up access to lifesaving hepatitis and HIV medicines for millions of people in the developing world. 🎙️MPP's @eburrone is addressing the @WHO Expert Committee on Selection&Use of #EssentialMedicines:✅important to plan for access NOW through early identification of promising new treatments✅MPP is ready to support future access to promising new meds through our licensing model pic.twitter.com/Ml3EzsPTm5 — MedicinesPatentPool (@MedsPatentPool) June 21, 2021 IFPMA Asks EML Experts to Recognize Countries’ Right to Choose On the other side of the fence, Sara Amini of the International Federation for Pharmaceutical Manufacturers and Associations (IFPMA), argued that while the WHO Essential Medicines List can be a “useful tool” guiding drug choices by countries and procurement agencies – it should not be portrayed as the final word on treatment choices by health-care providers. “IFPMA recognizes EML’s value as a foundational list of medicines that meets the priority healthcare needs of health systems and their populations,” Amini stated, “However, such decisions, while guided by EML, should also reflect each nation’s unique health landscape, taking into account national disease burden, health system capacities, and socio-cultural characteristics of the population. “As such, the EML should not be used as an impediment for governments, healthcare professionals or patients to adopt other treatment options, which may not be listed on the EML, but are deemed appropriate at a national level.” Defining Biologically Similar Drugs & Quality Assurance Another issue of concern for industry, Amini added, remains the WHO’s recommendations for the use of “biosimilar” versions of patented biological medicine treatments – often seen in the cancer arena as well as in other noncommunicable disease treatments. She said that the EML expert group should develop more refined terms of reference to such drugs in the EML context, including more precise definitions of what constitutes biologically equivalent drug formulations of certain biologically-based medications. EML recommendations for leading anti-cancer drugs, or their biosimilars, such as rituximab (RituxanⓇ) and trastuzumab (HerceptinⓇ) should also contain better definitions as to what constitutes a “quality-assured biosimilar”, she contended. Those definitions, Amini said, would be made in line with “WHO’s commitment to supporting globally acceptable principles for licensing biological products that are claimed to be similar to biological products of assured quality, safety, and efficacy on the basis of proven similarity.” Image Credits: WHO, Mike Sharland , Presentation by Mike Sharland, chair of the EML Working Group on Antibiotics . Ugandan Drug Authority Urges Maker of Popular COVID-19 Herbal Remedy to Conduct Clinical Trial 21/06/2021 Esther Nakkazi KAMPALA – As Uganda battles its worst COVID-19 outbreak, the government has called on a researcher who is selling a herbal remedy to treat COVID-19 to provide clinical proof that it works. Professor Patrick Engeu Ogwang is a renowned researcher in herbal medicines, head of pharmacy at Mbarara University of Science and Technology (MUST) and a former executive member of the Pharmaceutical Society of Uganda. He is also the founder of the herbal remedy which is being marketed as Covidex, a COVID-19 treatment although there is no proof that it works. The government has said it is willing to provide financial support to Ogwang to enable Covidex to go through proper clinical trials but that he should present scientific evidence of its efficacy and safety before marketing it as a treatment for the virus. “He is a very good researcher. We know him very well but he did this particular work alone. He has not shared it with anyone,” said Dr Monica Musenero, the Presidential Advisor on Epidemics and COVID-19. “We want to work with him and we are waiting for him to bring evidence. We are even willing to provide him with funding and even patients so that other people other than him tell us if the drug works and is safe,” she added. With the current second wave of the pandemic and a steep rise in COVID-19 cases, the government says people are desperate and they have a duty to protect the public. “All we see is information on social media of pictures of people lining up to buy the drug. We are not saying that the vaccine is bad or it does not work or is harmful. We just need evidence. Science is designed in a way that no single individual can claim that something works without convincing a panel of other people,” said Musenero. “The drug has not gone through clinical trials and as a person working with the World Health Organisation (WHO) I cannot make any more comments about it,” said WHO vaccines medical officer Dr Phiona Atuhebwe. “We all know what happened in Madagascar and Tanzania.” Dr Ambrose Talisuna, WHO Africa’s team leader on emergency preparedness, said that the remedy must undergo rigorous testing before being rolled out on the market. “People are gullible in a situation like this where there is a pandemic. My recommendation is for the Professor to take his drug through rigorous testing,” said Talisuna. Meanwhile, the Pharmaceutical Society of Uganda (PSU) has applauded Ogwang’s efforts to develop Covidex “considering that no proven cure for the pandemic has yet been established globally”. The PSU says it will stand by Ogwang and has already put in place a taskforce to provide him with technical support to develop Covidex in compliance with the established guidelines for research and development of herbal medicines. The PSU also said that it is engaging with Uganda’s drug regulatory body, the National Drug Authority (NDA), to ensure support for Ogwang. No Approval Given for Covidex, says NDA However, the NDA warned the public against using Covidex: “Uganda Drug Authority (NDA) has learnt with concern the promotion and sale of Covidex manufactured by Jena Herbals (U) Ltd that claims to prevent and treat COVID-19.” “NDA informs the public that it has not undertaken any assessment or approved Covidex, nor has it received any application from the innovator of the Covidex as required by National Drug Policy and Act cap 206,” said the NDA’s public relations manager, Abiaz Rwamwiri. The NDA has authorized a number of products from Jena Herbals, including an anti-malaria product, and notes that the company is aware of the process required for clinical trials, authorization, drug promotion and licensing before production and sale of herbal medicine. The NDA confirmed that it had met a team from Jena Herbals led by Ogwang and it had agreed to follow these necessary processes. After the meeting, Ogwang issued a statement saying that more proof was needed that Covidex worked to relieve the symptoms of COVID-19, and that the agency had advised him ti change the product;s name so it could not be associated with COVID-19. Ogwang told Health Policy Watch that his team was busy writing the clinical trial protocol which will be presented to the government. Earlier in this week there was a rush to buy Covidex and social media exchanges heightened after the statements from the government said it wanted scientific evidence. Covidex costs about UGX3,000 ($0.8) a unit pack, while a seven-day supply is UGX 21,000 ($6). South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub – WHO Asks Big Pharma to Support Scaleup 21/06/2021 Kerry Cullinan Afrigen is the lead partner in the South African mRNA hub Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday. But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan. WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed. If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday. South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity. “We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing. The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control. Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus. “In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros. Timelines Depend on Big Pharma Support WHO Chief Scientist Soumya Swaminathan If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. “The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan. “There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.” Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. French Welcome Hub to ‘Respond to Variants’ The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”. The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions. However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”. The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. “Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO. “Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.” WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears World Trade Organization Director-General Ngozi Okonjo-Iweala Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”. Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. “We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala. “At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added. She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda. “Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added. “In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.” The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient, shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.” South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. “Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi. He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians – and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production. Image Credits: Afrigen. Technical Fixes or Sweeping Reform? Europe and Developing Countries Face Uphill Battle to Etch Consensus on IP Waiver 18/06/2021 Elaine Ruth Fletcher Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines. Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”. But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June. That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks. #TRIPS Council of #WTO to hold series of meetings till July-end on patent waiver proposal #TRIPSwaiver https://t.co/ImqkiTd4dU via @timesofindia — Alicia Nicholls (@LicyLaw) June 17, 2021 European Union – More ‘Targeted’ Approach The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by: Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license; Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license; Reducing now complex requirements around detailed notification to the WTO of products being exported and where – which can delay their implementation; The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic – precluding the need for a blanket IP waiver. Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. South African and Indian Delegations – Discuss Scope of Waiver and Products Covered At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed. Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic. The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said. READ: 3 reasons why the EU´s #TRIPSWaiver counter-proposal is an insufficient solution in a pandemic #COVID19 💊🔬💉⬇️ https://t.co/4yO2zv6Imt pic.twitter.com/o4kQC55fCL — MSF Access Campaign (@MSF_access) June 18, 2021 And despite the streamlining of compulsory license rules that the EU has proposed, MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” “Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.” United States: Focus On Common Objectives The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached. US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus. The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests. The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal. The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods? Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry. “The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. “Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” Image Credits: Shutterstock. Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Ugandan Drug Authority Urges Maker of Popular COVID-19 Herbal Remedy to Conduct Clinical Trial 21/06/2021 Esther Nakkazi KAMPALA – As Uganda battles its worst COVID-19 outbreak, the government has called on a researcher who is selling a herbal remedy to treat COVID-19 to provide clinical proof that it works. Professor Patrick Engeu Ogwang is a renowned researcher in herbal medicines, head of pharmacy at Mbarara University of Science and Technology (MUST) and a former executive member of the Pharmaceutical Society of Uganda. He is also the founder of the herbal remedy which is being marketed as Covidex, a COVID-19 treatment although there is no proof that it works. The government has said it is willing to provide financial support to Ogwang to enable Covidex to go through proper clinical trials but that he should present scientific evidence of its efficacy and safety before marketing it as a treatment for the virus. “He is a very good researcher. We know him very well but he did this particular work alone. He has not shared it with anyone,” said Dr Monica Musenero, the Presidential Advisor on Epidemics and COVID-19. “We want to work with him and we are waiting for him to bring evidence. We are even willing to provide him with funding and even patients so that other people other than him tell us if the drug works and is safe,” she added. With the current second wave of the pandemic and a steep rise in COVID-19 cases, the government says people are desperate and they have a duty to protect the public. “All we see is information on social media of pictures of people lining up to buy the drug. We are not saying that the vaccine is bad or it does not work or is harmful. We just need evidence. Science is designed in a way that no single individual can claim that something works without convincing a panel of other people,” said Musenero. “The drug has not gone through clinical trials and as a person working with the World Health Organisation (WHO) I cannot make any more comments about it,” said WHO vaccines medical officer Dr Phiona Atuhebwe. “We all know what happened in Madagascar and Tanzania.” Dr Ambrose Talisuna, WHO Africa’s team leader on emergency preparedness, said that the remedy must undergo rigorous testing before being rolled out on the market. “People are gullible in a situation like this where there is a pandemic. My recommendation is for the Professor to take his drug through rigorous testing,” said Talisuna. Meanwhile, the Pharmaceutical Society of Uganda (PSU) has applauded Ogwang’s efforts to develop Covidex “considering that no proven cure for the pandemic has yet been established globally”. The PSU says it will stand by Ogwang and has already put in place a taskforce to provide him with technical support to develop Covidex in compliance with the established guidelines for research and development of herbal medicines. The PSU also said that it is engaging with Uganda’s drug regulatory body, the National Drug Authority (NDA), to ensure support for Ogwang. No Approval Given for Covidex, says NDA However, the NDA warned the public against using Covidex: “Uganda Drug Authority (NDA) has learnt with concern the promotion and sale of Covidex manufactured by Jena Herbals (U) Ltd that claims to prevent and treat COVID-19.” “NDA informs the public that it has not undertaken any assessment or approved Covidex, nor has it received any application from the innovator of the Covidex as required by National Drug Policy and Act cap 206,” said the NDA’s public relations manager, Abiaz Rwamwiri. The NDA has authorized a number of products from Jena Herbals, including an anti-malaria product, and notes that the company is aware of the process required for clinical trials, authorization, drug promotion and licensing before production and sale of herbal medicine. The NDA confirmed that it had met a team from Jena Herbals led by Ogwang and it had agreed to follow these necessary processes. After the meeting, Ogwang issued a statement saying that more proof was needed that Covidex worked to relieve the symptoms of COVID-19, and that the agency had advised him ti change the product;s name so it could not be associated with COVID-19. Ogwang told Health Policy Watch that his team was busy writing the clinical trial protocol which will be presented to the government. Earlier in this week there was a rush to buy Covidex and social media exchanges heightened after the statements from the government said it wanted scientific evidence. Covidex costs about UGX3,000 ($0.8) a unit pack, while a seven-day supply is UGX 21,000 ($6). South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub – WHO Asks Big Pharma to Support Scaleup 21/06/2021 Kerry Cullinan Afrigen is the lead partner in the South African mRNA hub Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday. But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan. WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed. If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday. South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity. “We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing. The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control. Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus. “In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros. Timelines Depend on Big Pharma Support WHO Chief Scientist Soumya Swaminathan If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. “The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan. “There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.” Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. French Welcome Hub to ‘Respond to Variants’ The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”. The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions. However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”. The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. “Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO. “Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.” WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears World Trade Organization Director-General Ngozi Okonjo-Iweala Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”. Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. “We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala. “At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added. She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda. “Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added. “In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.” The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient, shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.” South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. “Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi. He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians – and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production. Image Credits: Afrigen. Technical Fixes or Sweeping Reform? Europe and Developing Countries Face Uphill Battle to Etch Consensus on IP Waiver 18/06/2021 Elaine Ruth Fletcher Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines. Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”. But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June. That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks. #TRIPS Council of #WTO to hold series of meetings till July-end on patent waiver proposal #TRIPSwaiver https://t.co/ImqkiTd4dU via @timesofindia — Alicia Nicholls (@LicyLaw) June 17, 2021 European Union – More ‘Targeted’ Approach The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by: Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license; Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license; Reducing now complex requirements around detailed notification to the WTO of products being exported and where – which can delay their implementation; The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic – precluding the need for a blanket IP waiver. Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. South African and Indian Delegations – Discuss Scope of Waiver and Products Covered At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed. Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic. The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said. READ: 3 reasons why the EU´s #TRIPSWaiver counter-proposal is an insufficient solution in a pandemic #COVID19 💊🔬💉⬇️ https://t.co/4yO2zv6Imt pic.twitter.com/o4kQC55fCL — MSF Access Campaign (@MSF_access) June 18, 2021 And despite the streamlining of compulsory license rules that the EU has proposed, MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” “Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.” United States: Focus On Common Objectives The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached. US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus. The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests. The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal. The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods? Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry. “The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. “Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” Image Credits: Shutterstock. Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub – WHO Asks Big Pharma to Support Scaleup 21/06/2021 Kerry Cullinan Afrigen is the lead partner in the South African mRNA hub Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday. But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan. WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed. If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday. South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity. “We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing. The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control. Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus. “In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros. Timelines Depend on Big Pharma Support WHO Chief Scientist Soumya Swaminathan If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. “The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan. “There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.” Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. French Welcome Hub to ‘Respond to Variants’ The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”. The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions. However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”. The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. “Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO. “Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.” WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears World Trade Organization Director-General Ngozi Okonjo-Iweala Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”. Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. “We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala. “At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added. She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda. “Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added. “In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.” The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient, shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.” South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. “Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi. He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians – and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production. Image Credits: Afrigen. Technical Fixes or Sweeping Reform? Europe and Developing Countries Face Uphill Battle to Etch Consensus on IP Waiver 18/06/2021 Elaine Ruth Fletcher Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines. Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”. But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June. That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks. #TRIPS Council of #WTO to hold series of meetings till July-end on patent waiver proposal #TRIPSwaiver https://t.co/ImqkiTd4dU via @timesofindia — Alicia Nicholls (@LicyLaw) June 17, 2021 European Union – More ‘Targeted’ Approach The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by: Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license; Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license; Reducing now complex requirements around detailed notification to the WTO of products being exported and where – which can delay their implementation; The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic – precluding the need for a blanket IP waiver. Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. South African and Indian Delegations – Discuss Scope of Waiver and Products Covered At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed. Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic. The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said. READ: 3 reasons why the EU´s #TRIPSWaiver counter-proposal is an insufficient solution in a pandemic #COVID19 💊🔬💉⬇️ https://t.co/4yO2zv6Imt pic.twitter.com/o4kQC55fCL — MSF Access Campaign (@MSF_access) June 18, 2021 And despite the streamlining of compulsory license rules that the EU has proposed, MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” “Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.” United States: Focus On Common Objectives The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached. US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus. The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests. The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal. The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods? Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry. “The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. “Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” Image Credits: Shutterstock. Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Technical Fixes or Sweeping Reform? Europe and Developing Countries Face Uphill Battle to Etch Consensus on IP Waiver 18/06/2021 Elaine Ruth Fletcher Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines. Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”. But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June. That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks. #TRIPS Council of #WTO to hold series of meetings till July-end on patent waiver proposal #TRIPSwaiver https://t.co/ImqkiTd4dU via @timesofindia — Alicia Nicholls (@LicyLaw) June 17, 2021 European Union – More ‘Targeted’ Approach The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by: Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license; Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license; Reducing now complex requirements around detailed notification to the WTO of products being exported and where – which can delay their implementation; The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic – precluding the need for a blanket IP waiver. Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. South African and Indian Delegations – Discuss Scope of Waiver and Products Covered At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed. Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic. The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said. READ: 3 reasons why the EU´s #TRIPSWaiver counter-proposal is an insufficient solution in a pandemic #COVID19 💊🔬💉⬇️ https://t.co/4yO2zv6Imt pic.twitter.com/o4kQC55fCL — MSF Access Campaign (@MSF_access) June 18, 2021 And despite the streamlining of compulsory license rules that the EU has proposed, MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” “Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.” United States: Focus On Common Objectives The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached. US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus. The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests. The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal. The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods? Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry. “The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. “Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” Image Credits: Shutterstock. Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Are Chinese COVID Vaccines Underperforming? A Dearth of Real-Life Studies Leaves Unanswered Questions 18/06/2021 Svĕt Lustig Vijay From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2. At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels. “We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday. WHO Chief Scientist Soumya Swaminathan She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far. Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister. Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far. Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region Vaccine Efficacy Ratings For Sinovac And Sinopharm According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials. The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing. In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs. The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent. One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population. The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day. Complex Factors At Work The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts – to respond anecdotally. Dr Bruce Aylward, Senior Advisor to the WHO Director General For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission. “There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. “But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.” Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play: “In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch: “That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.” Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2. WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent. “If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?” said Swaminathan. “I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.” Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited” People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science. WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease. Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil. The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases. Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing. If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. China has already delivered 272 million doses to at least 40 countries ‘Literally Everyone Needs to be Vaccinated’ Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch. She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission. If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. “As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.” -Elaine Ruth Fletcher contributed to this story. Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput. Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Indian Bar Association Rebukes WHO Chief Scientist Over Ivermectin Guidelines for COVID Treatment 18/06/2021 Raisa Santos & Elaine Ruth Fletcher WHO Chief Scientist Soumya Swaminathan The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy. The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.” The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” “The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. “WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence. WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment Anti-parasitic drug Ivermectin The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use. It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.” Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments. Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” Evidence based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians. Should be translated and disseminated in all Indian languages.Can be updated as and when new evidence becomes available @drharshvardhan @WHOSEARO https://t.co/xNX0Ngj35y — Soumya Swaminathan (@doctorsoumya) June 6, 2021 Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Africa’s COVID-19 Surge is Expected to Worsen, Warns WHO 18/06/2021 Kerry Cullinan Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021. The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus. “Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing. “Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added. Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages. “The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme. Ryan added that this was “the consequence of the current unfair distribution of vaccines”. “If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan. Negotiations with AstraZeneca WHO’s COVAX lead, Bruce Aylward Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India. “We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward. He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence. “It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.” In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. “We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems. Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace. “Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.” Vaccine Inequity is ‘Fuelling Two-track Pandemic’ WHO Director General Dr Tedros Adhanom Ghebreyesus “The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros. “More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros. This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated. Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases. Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. “We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.” Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa. Image Credits: EAC, Western Cape government, WHO. Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
Stricter Laws Needed to Fight Child Labour on Tobacco Farms 18/06/2021 Geoffrey Kamadi Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains. With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms. Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse. “This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC. Child Labour Increases For the First Time in Two Decades The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms. It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19. According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo. She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor. According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world. These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia. Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control. In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming. Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe. “What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita. In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments. “Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi. Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school. Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. “Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.” Poverty is the Driver of Child Labour Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members. And that is why, explained Marquizo, sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. “This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025. She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda. Partners in Development The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT). Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019. “I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added. Mechanism Developed to Help the Transition of Tobacco Farmers. One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of WHO FCTC Article 17 and 18. The sections of the FCTC recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and calls for the protection of the environment and the health of those involved in the cultivation and manufacture of tobacco. The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago. “We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP. A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton. This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming. But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness. Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton. Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia. Image Credits: Unfairtobacco.org, WHO FCTC. Posts navigation Older postsNewer posts