Dr Nono Simelela, WHO Assistant Director-General for Strategic Programmatic Priorities: Cervical Cancer Elimination.

At least 70% of women should be screened for cervical cancer via high-performing DNA-based tests to identify the human papillomavirus (HPV), not a visual inspection with acetic acid or a Pap smear, which are more common. 

The HPV DNA test is not only more accurate, but it is also more cost-effective, according to the World Health Organization (WHO), which launched new guidelines on screening and treatment to prevent cervical cancer on Tuesday.

“Effective and accessible cervical screening and treatment programmes in every country are non-negotiable if we are going to end the unimaginable suffering caused by cervical cancer,” said Dr Nono Simelela, WHO Assistant Director-General for Strategic Programmatic Priorities: Cervical Cancer Elimination. 

“This new WHO guideline will guide public health investment in better diagnostic tools, stronger implementation processes and more acceptable options for screening to reach more women –  and save more lives,” she told a webinar to launch the guidelines.

Last year more than half a million women contracted cervical cancer, and about 342 000 women died as a result – most in the poorest countries.

The guidelines recommend important shifts in care, including more access to self-sampling to achieve the goal of having 70% of women aged between 35 and 40 tested by 2030 and at least 90% of people who need treatment to receive it.

“Studies show that women often feel more comfortable taking their own samples, for instance in the comfort of their own home, rather than going to see a provider for screening. However, women need to receive appropriate support to feel confident in managing the process,” WHO said in a statement.

This, said WHO, paired with screening women for HPV and vaccinating girls against HPV, may help prevent more than 62 million deaths from cervical cancer in the next century.

More Research Needed to Combat Cervical Cancer

Several experts also highlighted the need for more research, training of health professionals and destigmatising the disease to combat one of the biggest killers of women, particularly those in poor countries.

They said research into HPV should not only be focused on medical objectives, but should include social and political activism if deaths are to be prevented.

Professor Lynette Denny, a South African gynaecologist and champion of cervical cancer, described cervical cancer as “a disease of poverty, but also a disease of prejudice”.

“It’s a disease of saving some lives over others,” said Denny who called on research to be extended to patients’ history and the social impacts of women post HPV-diagnosis.

“When we talk about research, we have to talk about where are our patients coming from. What are they experiencing on a day-to-day basis and what are we as researchers, and healthcare professionals hearing,” said Denny.

“There have been some studies [that show] that if a woman dies and her child is under the age of 10, the chances that that child will live to 10-years-old are about 25%. And this is what’s happening in many, many countries as well where women are dying, and have young children in communities that often are unable to take care of these children without the support of the mother.”

Responding to the Link Between HPV and HIV

And while experts called for more research into HPV, WHO said more emphasis needs to be made on the link between HPV and HIV, as women with HIV are six times more likely to get HPV than those without HIV.

With HPV being the main driver behind most cervical cancer diagnoses, this cannot be overlooked.  The guidelines state that women with HIV should start cervical cancer screening at an earlier age (25) as opposed to the general population recommendation of 30 years.

“With these new guidelines, we must leverage the platforms already developed for HIV care and treatment to better integrate cervical cancer screening and treatment to meet the health needs and rights of the diverse group of women living with HIV to increase access, improve coverage, and save lives,” said Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes.

WHO recommends that all women who test positive for cervical cancer should receive treatment soon after diagnosis.

“Cost-effectiveness of screening tests is important for scaling up programmes, but other aspects of the public health approach to eliminating cervical cancer are also vital,” said Dr. Nathalie Broutet, WHO Department of Sexual and Reproductive Health and Research and HRP. “What matters most is the coherence of every country’s programme in ensuring the continuum of care: that all women have access to screening, health care providers are informed in a timely manner about the results of the screening test and can in turn share this information with their client, and that women can access appropriate treatment or referral if needed.”

Professor Groesbeck Parham, Director of the CIDRZ Cervical Cancer Prevention Program, professor of gynaecological oncology at UNC-Chapel Hill, agreed with Denny and said that despite technological advances in trying to understand cervical cancer, “we won’t get very far unless we put this disease in the women who have it in the proper social context”

“That’s the only thing that’s going to drive this off the planet as a social movement, because it is a social disease. Women diagnosed with HPV are often stigmatised and live in shame, and this needs to be addressed, said Parham.

Image Credits: WHO.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the ACT-Accelerator Facilitation Council Briefing on Tuesday.

As many high-income countries are relaxing restrictions for the summer months, low- and middle-income countries (LMICs) are witnessing rises in cases, deaths, and overwhelmed hospitals. 

Countries in Europe and the United States are increasingly allowing in travellers, ending mask mandates, and allowing large gatherings including football matches and concerts. 

At the same time, the third wave is intensifying in several countries, with critical oxygen shortages rising in sub-Saharan Africa, Southeast Asia, and parts of Latin America. Some 19 countries are about to run out of oxygen.

“We face a two-track pandemic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, at the ACT-Accelerator Facilitation Council Briefing on Tuesday. “The countries that are now opening up their societies are those that have largely controlled the supply of life-saving personal protective equipment [PPE], tests, oxygen, and especially vaccines.”

“Meanwhile, countries without access to sufficient supplies are facing waves of hospitalizations and deaths,” Tedros said. 

“While some parts of the world go on to enjoy summer vacation in near normality, others brace themselves for overwhelmed hospitals and economies on the brink of collapse,” said Dag-Inge Ulstein, Norway’s Minister of International Development and Co-chair of the ACT-Accelerator Facilitation Council. 

Pandemic is in a ‘Very Dangerous Phase’

After weeks of decline, global COVID-19 cases are now on the rise in five of the six WHO regions. The African region is currently experiencing a fast-surging third wave that could pose a far greater threat to the continent than the second wave. 

“We shouldn’t be in this position 18 months into a global pandemic where all of us are exhausted and with more than 183 million confirmed cases and 3.9 million deaths,” said Maria Van Kerkhove, WHO COVID-19 Technical Lead. 

Over 20 countries globally have an exponential growth in cases and “almost vertical transmission,” said Van Kerkhove. 

The global epidemiological report separated by region, as of 5 July 2021.

This is largely being driven by the Delta variant, first identified in India and classified as a “variant of concern” by WHO in mid-May. It is considered 40-60% more transmissible than the Alpha variant, identified in the United Kingdom. 

More than 96 countries have reported the Delta variant and it is expected to become the dominant virus in the coming months. 

The pandemic “remains in a very dangerous phase,” with the continual emergence of variants, inequitable vaccinations, and overburdened health systems, said Tedros. 

“Most of the world remains susceptible to infection,” due in part to the uneven rollout of vaccines globally and the inconsistent implementation of public health and social measures around the world, said Van Kerkhove. 

“Urgent action is required, not only to redress inequitable access to health care and to vaccines, but to ensure that countries have the capacity to translate vaccines into vaccination, diagnostics into effective surveillance, and therapeutics into treatment,” said Van Kerkhove. 

The WHO identified priority actions for member states, namely to: enhance national, regional, and global surveillance, testing, clinical care, and access to oxygen and therapeutics; maintain focus on public health and social measures to suppress transmission; scale up the research, production of and equitable distribution of vaccines, diagnostics, and therapeutics; and strengthen the capacity and resilience of health systems.

Inequities are Decreasing, But Stark Disparities Remain

While a global milestone of administering three billion doses has been reached, only 0.3% of those have gone to low-income countries. Of the 2.6 billion COVID tests performed globally, less than 4% have been administered in Africa, which accounts for 17% of the world’s population.

While vaccine deployment is improving everywhere in the world, there are still stark disparities between the regions in terms of coverage.

No low-income countries have achieved more than 20% vaccination coverage nationally, compared to 80% of high-income countries.

Some 68 WHO member states have reached 20% coverage, the majority from the European region. The African region and Southeast Asian region have the lowest share of countries with coverage over 20%. 

The share of WHO member states with COVID-19 vaccine coverage over 20%.

Vaccine inequity is gradually decreasing, but high-income countries have still administered 63 times more doses per inhabitant than low-income countries. Of the 194 WHO member states, 189 have started vaccinating. 

“These persistent inequalities are translating into countless preventable deaths while the world has the tools to stop this,” said Mmamoloko Kubayi, Acting Minister of Health of South Africa and Co-chair of the ACT-Accelerator Facilitation Council.

Mmamoloko Kubayi, South Africa’s Acting Minister of Health and Co-chair of the ACT-Accelerator Council.

“We need to mobilise resources to fund medical oxygen storage and infrastructure, pay for emergency supplies, and finance the transportation of equipment and other tools needed,” said Kubayi. 

“Our only way out [of the pandemic] is to support countries in the equitable distribution of PPE, tests, treatments, and vaccines,” said Tedros.

“This pandemic is testing our ability to save lives, but also our ability to save the architecture of international cooperation that we spent so many decades building,” added Ulstein. 

Constraints on COVAX Vaccination Progress 

COVAX has shipped 95.9 million doses to 135 countries, including 69 low- and middle-income countries. Some 40 countries began their vaccination campaigns because of COVAX.

“We should have been at a much higher level of distribution by now, perhaps between 300- and 400 million doses, but because of the constraints…we have yet to touch 100 million,” said Soumya Swaminathan, WHO Chief Scientist. 

A global map of the countries that have received doses from COVAX, as of 5 July 2021.

COVAX is currently facing supply shortages primarily due to delays in clinical trials, regulatory approvals, the validation of new manufacturing sites, supply chain bottlenecks, and export controls. 

“In recognition of these risks that we are facing, we’re very much focused on having a diversified portfolio of vaccines…in terms of resilience across different manufacturing sites across the globe and having a very actively managed portfolio,” said Aurelia Nguyen, Managing Director of the COVAX Facility. 

WHO officials expect to have a “very strong increase” in vaccines available to COVAX in the fourth quarter of 2021 with additional vaccines getting WHO emergency use listing (EUL) and scale ups in vaccine manufacturing. 

The hope is also that exports of the AstraZeneca vaccine from the Serum Institute of India (SII), a major source of doses for the COVAX Facility, will resume in late 2021. 

Supplies from the SII manufacturing site were redirected to address the domestic surge in cases and deaths in April, causing delays in COVAX deliveries to low- and middle-income countries. 

Boosting the availability of vaccines immediately will require dose sharing from countries with a surplus of vaccines. Several countries have committed over 530 million doses to COVAX, with the commencement of deliveries from France, New Zealand, and the US. 

Four new manufacturers have signed up with COVAX – Moderna, Novavax, Johnson & Johnson, and Clover, a Chinese biotech firm – committing 1.5 billion doses. 

As a result of the new deal and ongoing negotiations, COVAX expects “substantial volumes” of vaccines through 2021 and early 2022, said Nguyen.

“We are forecasted to have approximately 1.9 billion doses available for delivery by the end of 2021 and of this, the advanced market commitment participants, the 92 lower-income economies, are expected to receive 1.5 billion doses of that,” said Nguyen.

The global supply forecast of the COVAX Facility for 2021 and 2022.

Appeal for Funding for the ACT-Accelerator

As of the end of June, US$17.7 billion was raised for the Access to COVID-19 Tools (ACT) Accelerator – an initiative to speed up the development, production, and access to tests, treatments, and vaccines – but a considerable gap in funding remains, said officials at the Facilitation Council meeting. 

ACT-A has a funding gap of US$16.8 billion, two-thirds of which is needed for the supply diagnostics and PPE. The rest is intended for R&D and manufacturing, the health systems connector pillar of ACT-A, and the supply of therapeutics and oxygen. 

Some 60% of the total supply need for diagnostics and therapeutics is in LMICs. 

Particularly in the context of the current surge in cases, “there is an urgency to ensure that the ACT-Accelerator’s financing needs are met,” said Michaela Pfeiffer, WHO Technical Officer of ACT-A Hub. 

As the world approaches the “sobering juncture” of four million lives lost from COVID-19, funding commitments to ACT-A are critical, said Ulstein.

WHO officials called on the Group of 20 (G-20), an intergovernmental forum for economic collaboration, to not delay financial commitments to the Accelerator. 

“Our appeal for countries to finance ACT-A is not new, but it is ever more relevant,” said Ulstein. 

Dag-Inge Ulstein, Norway’s Minister of International Development and Co-chair of the ACT-Accelerator Facilitation Council.

In addition to financing, countries were also called upon to share vaccines, as at least 250 million doses will be needed to reach 10% vaccine coverage in all countries by September. 

The pharmaceutical industry and manufacturers have a role to play in scaling up production and facilitating technology transfer to improve the global vaccine manufacturing capacity. 

“We need manufacturers to help by sharing know-how and accelerating technology transfer,” said Tedros. 

“The stakes are high and the challenges before us are vast, but not insurmountable,” said Ulstein. “A clear message has been sent that the solutions exist, it is only that we need to have the political will to realize them and ensure that everyone everywhere has access to life saving measures.”

Image Credits: WHO.

The Swiss-based journal Vaccines has retracted a controversial paper linking deaths to COVID-19 vaccines, which prompted the resignation of six members of its editorial board last week.

The paper was titled ‘The Safety of COVID-19 Vaccinations – We Should Rethink the Policy’, and it attracted massive support from anti-vaxxers who question the safety of vaccines.

Prior to its retraction, the journal issued an “expression of concern” flagging that “serious concerns have been raised about misinterpretation of the data and the conclusions” in the paper, particularly that three deaths reported to be linked to vaccinations is “incorrect and distorted”.

The paragraph that attracted the most controversy argued: “The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.”

The  paper based its statistics on adverse effects and deaths on data from Netherlands Pharmacovigilance Center, called Lareb. However, anyone can report an adverse effect or death on the database without independent medical verification. After the paper was published, Lareb’s head of science and research, Eugène van Puijenbroek, wrote to the journal and requested that it retract the paper.

The paper listed as its corresponding author the controversial German psychologist Harald Walach. In 2012, he received the Goldene Brett vorm Kopf  (golden blockhead) ‘prize’ for promoting pseudo-science from the German Society for the Scientific Investigation of Pseudosciences.

Walach and co-authors medical physicist Rainer Klement and data analyst Wouter Aukema, responded to Retraction Watch about the retraction of their paper by saying: “We used imperfect data correctly. We are not responsible for the validity and correctness of the data, but for the correctness of the analysis. We contend that our analysis was correct.”

Editorial board resignations include virologist Florian Krammer, from Icahn School of Medicine at Mount Sinai; Oxford University immunologist Katie Ewer, who helped to develop the Oxford-AstraZeneca COVID-19 vaccine; New Zealand vaccinologist Helen Petousis-Harris; epidemiologist Diane Harper from the University of Michigan; Australian immunologist Paul Licciardi from Murdoch Children’s Research Institute and virologist Andrew Pekosz from the Johns Hopkins University Bloomberg School of Public Health, according to Science magazine.

 

 

 

Image Credits: International Monetary Fund/Ernesto Benavides.

A COVID-19 outreach program in Karnataka state, India.

Despite a series of controversies, Bharat Biotech, which produces Indian homegrown vaccine Covaxin, hopes for World Health Organization (WHO) emergency use listing (EUL) soon, following last week’s publication of its promising Phase 3 results.

The vaccine was given emergency authorisation by the Indian government in early January – even before it had concluded a Phase 3 trial or published its Phase 2 results.  It has since been accused of irregularities during its Phase 3 trial and of being involved in a corrupt deal in Brazil.

However, Bharat finally published a preprint of its Phase 3 trial results via the BMJ’s reputable preprint service last week, which showed that Covaxin had 93.4% protection against severe COVID-19, and 65.2% protection against the Delta variant. 

The trial involved 25,798 people between the ages of 18 to 98 years in 25 sites across India. But trialists at the Bhopal site reported that they had been paid $10 to take part and some had been unable to read the consent form as they were illiterate, according to media reports. 

While these results still have to be peer-reviewed, the company is in the process of submitting “rolling data” to the WHO, according to the WHO EUL status report.

Over the weekend, Bharat company chairperson and managing director Dr Krishna Ella said that that the trial results had established India and developing world countries’ ability to “focus on innovation and novel product development”.

The Indian Council of Medical Research (ICMR) has worked with the company to develop the vaccine, and Balram Bhargava, ICMR Director and India’s Secretary of the Department of Health Research, welcomed the results.

Describing the trial as India’s largest COVID-19 Phase 3 clinical trial, Bhargava said that Covaxin “has consolidated the position of Indian academia and industry in the global arena”.

Corruption Allegations in Brazil

However, the company has also been embroiled in a corruption scandal in Brazil, which resulted in the suspension last week of a 20 million-dose order of the vaccine worth $324-million pending the outcome of investigations. The allegations of irregularities reach as high as President Jair Bolsanaro, according to Quartz.

The issue was raised by India’s opposition Congress Party last Friday, which accused the Modi government of being “conspicuously silent” about the deal with Brazil despite the fact that public money had been used to develop the vaccine.

“Taxpayers’ money was put into this and which is why we have a right to question: what has happened with that money and why is the government conspicuously silent on it?” according to Congress spokesperson Supriya Shrinate, who claimed that the ICMR was to get 5% from the sale of the vaccine.

Part of the Brazilian scandal centres on a company linked to Bharat, which is apparently tried to act as a ‘broker’, selling the vaccines on to the Brazilian government at the vastly inflated price of $15 per dose. This is more expensive than the Pfizer vaccine, which has WHO EUL.

A whistleblower in the Brazilian Health Department told a Senate panel that he was facing pressure from an aide of a close ally of Bolsonaro to sign a contract for the vaccines at a massively inflated price, according to the Guardian

Ministry head of imports Luis Ricardo Miranda, told the panel that he had not approved an import license for the vaccine because an invoice for the first shipment asking for upfront payment had been sent by a company not mentioned in the contract.

Wagner de Campos Rosário, of the federal office of the comptroller general, said in a press briefing reported by CNN Brasil last week that the deal had been suspended “as a simple preventive measure, since there are complaints that could not be explained well by the complainant”. He expected the investigation to take around 10 days.

However, both Bharat and Bolsonaro have denied wrongdoing.

Image Credits: Flickr – Trinity Care Foundation, Flickr – Trinity Care Foundation.

Antibiotics are commonly used in animals to boost their growth and keep them from picking up infections.

Their consensus was inevitable. As the 74th World Health Assembly (WHA) discussed a solution in May to contain the grave and growing threat of antimicrobial resistance (AMR), one mandate emerged: any action must take a multisectoral One Health approach to human, animal, and environmental health. 

Antibiotics are commonly used in animals – often without the input of veterinarians – to boost their growth and keep them from picking up infections. Estimates indicate that more than 70% of the antimicrobials sold globally are used in animals, and in some countries up to 80%, mostly for growth promotion. This indiscriminate antimicrobial use fuels resistance. 

Drug-resistant germs can cross over from animals to humans through direct contact with farm animals or through meat handling or consumption. Inappropriate antimicrobial use in animals is now recognized as a major contributor to drug resistance. 

Some 700,000 people already die due to antimicrobial resistance each year, and that may increase to millions per year if we don’t do more to stop inappropriate use of antibiotics. Meanwhile, rising incomes and growing urban populations throughout the world have increased the demand for meat, which means more livestock farming.

Many countries are eager to contain AMR. According to a WHA-related report, 144 countries now have a national action plan to do so. However, sectors differ in the amount of progress they’ve made. While there is general awareness and progress in the human health sector, work in the animal sector is lagging, and work in the environmental sector has only begun.

As the WHA affirmed, six years after it launched a Global Action Plan on AMR, we need collaborative, multisectoral coordination to address public health threats at the intersection of humans, animals, and the environment. It’s the only way to effectively address this widespread issue. 

The global health nonprofit I work for is supporting Global Health Security Agenda (GHSA) activities aimed at improving multisectoral coordination on AMR as part of the USAID Medicines, Technologies, and Pharmaceutical Services Program. We’ve worked in multiple countries, using WHO-recommended benchmarks to improve their capacity to detect, assess, report, and respond to public health events per International Health Regulations.

As my colleagues and I explained in a paper, “Strengthening multisectoral coordination on antimicrobial resistance: a landscape analysis of efforts in 11 countries,” it’s critical to help countries establish national multisectoral task forces and ensure that they function effectively. They must include high-level governmental officials and other stakeholders from both human and animal health, along with the agricultural, environmental, and food sectors.

Multi-sectoral Collaboration Needed to Tackle AMR

In some countries, these coordinating bodies lacked adequate political support and the authority to act. Ethiopia had weak coordination among its AMR stakeholders, no monitoring and evaluation capability to measure progress, no central reporting mechanism on AMR-related activities, and no functional technical working groups in line with One Health to actually implement activities against AMR. We convened national stakeholders to address these issues and improve overall functionality of the multisectoral coordination body on AMR and its technical working groups.

Countries need enabling environments such as administrative and financial support, adequate human resources, and practical know-how on the process and parameters of how these multi sectoral bodies operate. They also need ways to gather, analyze, and monitor data.

Support pays off: with our collaboration, the human, animal, agriculture, and environmental sectors in Cameroon collaborated on a plan to execute the country’s national action plan on AMR. Bangladesh and Kenya developed multisectoral monitoring and evaluation frameworks to track their action plans.

In Uganda, the Ministry of Agriculture, Animal Industry and Fisheries released its first-ever guidelines in February for antimicrobial use in animals.

Previous efforts by stakeholders to address AMR have largely been siloed. To get diverse sectors and disciplines to the table at the central level and to form mutual trust, frank discussions about why collaboration is critical, explaining the science, and finding common ground among sectors are needed.

The private sector has a stake in outcomes, too, especially as they relate to maintaining the effectiveness of medicines or protecting livestock.

Increasing drug resistance in E. coli, Salmonella, and other bacteria prompted Côte d’Ivoire to embark on an ambitious multi sectoral antimicrobial stewardship plan. Health and vet facilities began to monitor drug prescribing and  infection prevention and control procedures, while another committee looked into the sale of medicines without prescriptions and the sale of fake or substandard drugs. Greater attention to hygiene and prescribing also helped health facilities deal with the COVID-19 pandemic.

Every country needs the same inclusive approach. It is a big undertaking, and many lower-income countries are just beginning to achieve liftoff in implementing their national AMR plans. However, as we struggle to contain the COVID-19 pandemic, we cannot take our eyes off of the creeping global problem of AMR, which threatens to claim even more lives.

Dr Mohan P. Joshi

Mohan P. Joshi is a physician and senior principal technical advisor at the global health nonprofit Management Sciences for Health, where he is the technical lead for issues related to antimicrobial resistance and global health security.

Image Credits: Commons Wikimedia.

Gaston Browne, Prime Minister and Minister for Finance and Corporate Governance of Antigua and Barbuda, has called on wealthier countries to assist SIDS with a multitude of challenges, including on issues of climate change and COVID-19 vaccine sharing.

Small island states need more help to deal with the effects of climate change as well as the new challenges brought on by the COVID-19 pandemic, the first World Health Organization (WHO) Small Island Developing States (SIDS) Summit concluded this week.

Following a two day virtual SIDS Summit: For a healthy and resilient future in Small Island Developing States, heads of state, ministers of health, and other stakeholders released an outcome statement prioritising actions that would help them deal with the “acute and existential health and development threats” that they face.

The 25-point statement focuses on needed measures to battle COVID as well as other longstanding health threats, promote sustainable environments, as well as addressing the social and economic impacts of the pandemic – including the critical need to revive island state economies, often built around international tourism as well as trade.

The action plan also calls for more robust emergency preparedness, as well as healthy and sustainable food systems for the island nations beset by more extreme weather, rising sea levels, and related to that, the loss of beaches and mangroves rich in aquatic resources, cultivable land, as well as fresh water resources.

Addressing a WHO briefing on Friday to unpack the outcome statement, Gaston Browne, Prime Minister and Finance Minister of Antigua and Barbuda, said SIDS have been confronting climate challenges with limited resources, now exacerbated by the COVID pandemic.

“While we can list a few accomplishments, the world sometimes turns its back on us. This is happening perhaps a little too often and the pandemic is a typical example as to how the international community has failed to assist SIDS in equal ways…” said Browne.  

“This outcome statement requires action by all, and hinges on urgent interventions in addressing the unique vulnerability of SIDS and the inequalities that stand as obstacles to development.”

Vaccine Equity Paramount to Help Defeat the COVID-19 Pandemic

Browne took a swipe at the United States government which was recently asked to clarify whether sanctions against Cuba extend to collaborations on COVID-19 vaccine R&D – as the island nation develops two promising vaccine candidates, Abdala and Soberana 2. 

He applauded Cuba as a “small state that continues as a leader in healthcare and medicines”. Cuba, like many other SIDS, “are promoting the concept of universal health care with significant success despite the fiscal constraints,” he added.  

Browne also raised concerns about COVAX, the global vaccine-sharing facility, saying that small island states can’t get access: “Despite the good efforts of the COVAX facility, development partners are not doing enough,” he said. “Seems like we still have a problem with vaccine nationalization.”

“And that’s compounded by the fact that travel and trade have been curtailed, thereby inflicting red wounds on our economies. So, we now run the risk of disintegrating into what I consider to be economic sclerosis, eroding decades of hard won gains, and that should not be allowed to happen.Our tourism industry is all but at a standstill, said Brown, referring to the tourism trade which has long been a mainstay of many island states. 

“Our economies are shattered and there’s much anxiety among SIDS of the possibility of a protracted pandemic which means that we are left in lockstep with each other in global solidarity in order to effectively defeat this pandemic.”

The outcome statement notes that SIDS are vaccinating at lower rates than the global average and called on the G20 and others to share vaccine doses, testing equipment and other medical tools.

“The COVID-19 pandemic is not over. SIDS must not be left behind in the race to administer vaccines; support to date has been essential, but SIDS need wealthier countries to share more vaccine doses now ideally through COVAX,” reads the statement.

Less Words, More Action Backed by Financial Resources

WHO Director-General Dr Tedros Adhanom Ghebreyesus

WHO Director-General Dr Tedros Adhanom Ghebreyesus echoed Brown’s sentiments on countries working together on issues of climate change and further highlighted concerns around vaccine equity.

“Their (SIDS) very existence is at risk as (Brown) noted. The same is true for vaccine equity. In many respects many small island developing states have succeeded in preventing widespread transmission of COVID-19 in their communities.”

“We’re in a very dangerous period of this pandemic in those countries with low vaccination coverage, terrible scenes of hospitals overflowing are again becoming the norm, but no country on Earth is out of the woods yet,” said Dr Tedros.

He said the pandemic has “hit you hard in other ways”, in referring to declining revenues from tourism, significantly compounded by more transmissible variants like the Delta variant.

Tedros said “the time for lofty words is over” and called for “concerted action, backed by financial resources to mitigate the consequences of climate change, while we work to keep temperatures down and scale green innovations in terms of the small islands.”

SIDS Challenges to be Advocated at Global Meetings

The SIDS outcome statement also calls for:

  • SIDS health to be  addressed fully in the climate change movement – “One-Point-Five-to-Stay-Alive” – referring to the aspiration to keep average global temperatures below 1.5 C 
  • Healthy, sustainable and resilient food systems that focus on the preservation of biodiversity and deliver healthy diets are essential in SIDS;
  • Better access to COVID vaccines and others pandemic tools; and beyond the pandemic, support for fighting deepseated issues in maternal and child health, communicable and non-communicable diseases (NCDs);
  • More access to digital health technology and other tools for rapid data collection and analytic capacity; and
  • Access to development finance, including finance for the prevention and control of NCDs and climate change action.

Brown  however stressed the need for bolder action to achieve those objectives: 

“Recognizing the interconnectedness of human health and sustainable development requires tackling the social determinants of health while promoting economic resilience,” he said. 

With regards to COVID-19, the outcome statement also highlighted the impact the pandemic has had on mental health, including increased harmful use of alcohol, substance abuse, and gender-based violence, which increases needs for treatment services, social support and rehabilitation. 

To address these issues, the SIDS recommend the advancement of the updated Comprehensive Mental Health Action Plan 2013-2030 and expanded community-based mental health care.

The statement looks forward to upcoming global gatherings, including the UN Food Systems Summit, planned for September, the UN Framework Convention on Climate Change, Conference of Parties (COP26), in Glasgow 31 October-12 November,  and the Nutrition for Growth Summit, planned for December as venues where their agenda can be taken up more directly. Along with that, there is a planned SIDS high-level and ministerial meetings on NCDS in 2022 is another forum where countries will be able to advocate for more awareness and action. 

Image Credits: WHO.

India’s Stelis Biopharma manufacturing site, where the Russian Sputnik V vaccine will be produced

Despite the emergence of new WHO concerns over quality control at Sputnik V’s domestic production facilities, the Russian Direct Investment Fund (RDIF) is pushing ahead with a massive international “open-license” manufacturing effort for its Sputnik V vaccine – which breaks the traditional model of vaccine production and leverages existing capacity in poorer countries, desperate for doses.

As such, RDIF has “broken the model of closed intellectual property” and adopted a vaccine scale-up model that is “fundamentally different” to most vaccine developers, Leena Menghaney, Global IP Advisor for MSF’s Access Campaign, told Health Policy Watch in an interview.

But at the same time, a recent WHO review of manufacturing practices at one of the vaccine’s nine Russian plants identified a number of substandard manufacturing practices – illustrating how challenging quality control may be for the wider Russian model. 

The WHO review is not the only one to have found issues. 

Earlier this year, Brazil’s medicines regulator rejected Sputnik V’s request for approval, due to the contamination of some batches of the adenovirus vector, among other issues. 

Meanwhile, Slovakia’s regulator also has voiced concerns that the batches of Sputnik V it received did “not have the same characteristics and properties” as the version of Sputnik V reviewed in a Lancet study, which published favourable Phase III trial results for the vaccine earlier in February – with an efficacy of 91 % against symptomatic COVID-19 disease and 100% against severe COVID.

And the European Medicines Agency (EMA) has delayed Sputnik V’s approval following the RDIF’s failure to submit additional clinical trial data by a deadline that was initially set for early June.

At the same time, low- and middle-income countries, desperate for vaccines, have largely ignored such concerns. Since Russia’s own approval last August, almost seventy, mostly low- and middle-income countries have greenlighted the vaccine, which features a low price and easy storage requirements – and is even more attractive after India’s Serum Institute halted its AstraZeneca vaccine exports via the Global COVAX facility in March.

Even more significantly, a number of countries, including India, Serbia, Argentina, and Iran, have already begun their own mass production of Sputnik V vaccines. That includes half a dozen manufacturers in India, which are set to produce 65%-70% of Sputnik V’s global supply, or about 850 million doses or more a year, according to RDIF projections. 

Should those aims indeed be reached, the RDIF and its partners could potentially produce nearly 10% of the world’s total vaccines for 2021.


Non-Exclusive Deals With Multiple Manufacturers 

“The RDIF did what most vaccine developers and global health actors like the Bill and Melinda Gates Foundation should have done, which is to adopt a non-exclusive and open approach to vaccine manufacturing,” said Menghaney.

Instead of sealing exclusive licenses with a handful of manufacturers, the RDIF has shared its vaccine technology and know-how with some 27 manufacturers, predominantly based in India or upper middle income countries, according to the Geneva Graduate Institute’s COVID Vaccine Manufacturing Tracker.

That sets the RDIF apart from most other major pharma vaccine developers, which are primarily manufacturing, as well as distributing, vaccines in high-income countries – according to the Geneva Graduate Institute’s COVID Vaccine Manufacturing Tracker.

Pfizer and Moderna, for instance, have signed a total of 6 and 9 agreements, respectively, with manufacturers. All are based in high-income countries like France, Switzerland, or Germany – except for one deal between Pfizer/BioNTech and China’s Shanghai Fosun Pharmaceutical Group. Even Johnson & Johnson, which recently struck an expanded manufacturing deal with Aspen Pharmacare in South Africa, is primarily producing vaccines in the US and Europe.  And in the case of AstraZeneca, which has been the most aggressive in licensing production in low- or middle-income countries, including the Serum Institute of India, those licenses are exclusive.  

“The RDIF did not limit itself to one manufacturer,” added Menghaney. “If anyone wants [to produce] Sputnik V, they can go to RDIF and get it.”

The RDIF has sealed deals with manufacturers from upper middle income countries, in contrast to the rest of Western vaccine developers, which are primarily manufacturing, as well as distributing vaccines in high-income countries

Sharing Regulatory Dossiers within Countries

Another aspect of RDIF’s approach, also evidenced in India, has involved the sharing of the same vaccine “regulatory dossier” with multiple manufacturers. In India, those companies include: Dr. Reddy’s; Panacea Biotech; Stelis Pharma (Strides arm); Hetero; Gland Pharma; Virchow; and the Serum Institute of India, said Menghaney.

Sharing of dossiers is rarely done, due to trade secret and non-disclosure issues, Menghaney noted: “Instead of making manufacturers compete with each other, the RDIF encouraged them to produce the same common technical dossier and to work together to improve the yield of the vaccine.” 

The use of a common dossier not only hastened India’s regulatory approval of multiple new manufacturing facilities, but it has also allowed manufacturers to work together to optimise the yield of Sputnik V and to address quality control issues, such as contamination, which are common bottlenecks in the mass-production of adenovirus-based vaccines like Sputnik V. 

“The RDIF took a collaborative approach to manufacture the vaccine but also to scale it up,” said Menghaney, adding that no other company has adopted such a collaborative regulatory process for a COVID vaccine to date.

She contrasts that with AstraZeneca, which signed about a dozen exclusive deals with manufacturers, including the Republic of Korea and the Serum Institute of India, effectively blocking other manufacturers in the same country from bidding to produce the vaccine. 

The problems around such exclusivity, became more evident last spring, when the Serum Institute of India halted its exports of the AstraZeneca “Covishield” vaccine to over 100 low-income countries in Africa and elsewhere participating in the WHO co-sponsored COVAX vaccine facility after Indian COVID cases began to skyrocket. That, in turn, set off a domino effect, stalling vaccine campaigns that had only just begun in LMICs around the world, and leaving them more dependent than ever on vaccine donations from rich countries, or alternatively vaccines from China or Russia.

“The Serum Institute has an exclusive deal with AstraZeneca, and not just for India,” she said. “This probably means that these countries won’t be receiving any doses of the Oxford vaccine from other sources unless the agreement between AZ and SII is reviewed.”

The RDIF’s approach, she said, is all the more welcome to access advocates against the backdrop of still limited vaccine sharing pledges to the global COVAX facility and continuing reluctance by the big mRNA pharma firms, like Pfizer and Moderna to freely share their vaccine know-how.

RDIF Refuses To Reply On Manufacturing Quality Control Issues 

Despite that bright assessment, the preliminary WHO report, published last week, unearthed a number of concerning contamination issues at the Russian “Ufa Vitamin Plant” which manages the domestic Sputnik vaccine’s “fill and finish” process – where vaccine active ingredient is transformed into an injectible product.

WHO voiced six concerns with the plant, including: “integrity of data and test results”; potential “cross-contamination” of the batches; and poor hygiene standards. The report followed a WHO-led inspection between the 31st of May and the 4th of June. 

The Ufa Vitamin Plant asserted in a statement on June 23 that the WHO concerns were addressed “within 48 hours”. 

“Following the receipt of the comments from WHO, Ufa VITA responded to all the questions and concerns raised within 48 hours,” the firm announced last week. “We invite WHO for another inspection. We remain fully transparent and will continue with the WHO prequalification process.”

RDIF, however, has so far remained mum on the quality control issues raised by WHO – including non-response to queries by Health Policy Watch. 

And the WHO-reported concerns still remain outstanding, according to the public WHO dossier on the vaccine. 

WHO’s prequalification team flagged six concerns following its inspection of the Russian Ufa Vitamin Plant – a “fill-and-finish” facility

Sputnik V Approval Process: “Additional Data Required”

In response to a Health Policy Watch’s query, WHO declined to provide further clarifications, pointing only to its latest EUL update, dated 29 June, which continues to state, with respect to Sputnik V: 

“Additional data (Non-CLIN, CLIN, CMC) Required. Following up on inspection observations; Anticipated date [of approval] will be set once all data is submitted and followup of inspection observations completed.”

“Subject to certain requirements being met, WHO will continue to assess Sputnik V vaccines from different manufacturing sites and will publish decisions on their EUL status when all the data are available and the review is concluded,” WHO’s latest news update on Sputnik also stated.

Contamination Is a Common Concern 

Contamination is a common challenge faced by manufacturers of adenovirus-based vaccines, Ian Jones, Professor of Virology at the University of Reading in the UK, told Health Policy Watch. Potentially such contamination can make the adenovirus, which is supposed to remain non-infective, “replication-competent.” 

“The Sputnik V vaccine technology is basically just growing a virus,” he said. “However, it is not as trustworthy as the RNA as it is a biological, as opposed to chemical process. There are issues with yields, the risk of contamination and, for the adenovirus vectors [which deliver the vaccine], the need to measure the levels of ‘real’ adenovirus, a small amount of which is generated as part of the process. So, in many ways the older technology is a less good technology than mRNA technology.”

Ensuring high hygiene standards in all vaccine production facilities, including fill-and-finish facilities, remains “very important”, emphasized Jones, to avoid contamination of batches with other pathogens as well.

“High hygiene is very important in all such facilities to avoid bacterial contamination. The material will be injected, so passes the skin that normally acts as a barrier to pathogen entry,” he observed.

Contamination is a common issue in the scale-up of adenovirus-based vaccines

Pharma Manufacturers Say RDIF Issues Illustrate Challenges They Face 

Pharma leaders have repeatedly asserted that quality control issues, such as the ones identified by WHO at the RDIF plant, are illustrative of the challenges that they would face were they to issue open licenses as a means of scaling up vaccine production – as per the RDIF model.   

“It’s a very complex sector, with complicated science, very complicated manufacturing processes, we have to be very careful to whom we transfer the know-how, in particular because of the imperative of safety and quality,” said Bharat Biotech’s Executive Director of Quality Operations Sai Prasad, who is also President of the Developing Countries Vaccine Manufacturers’ Network (DCVMN), at an IFPMA-hosted webinar in late April. Bharat Biotech developed India’s first indigenous COVID vaccine – although that, too, has yet to gain WHO approval.  

“…. Don’t underestimate the requirements of standardized, manufacturing, quality control, and quality assurance,” Thomas Cueni, Director General of the International Federation of Pharmaceutical Producers (IFPMA), told Health Policy Watch in a recent interview.  

Stephane Bancel, CEO of Moderna

Speaking at an April 2021 event, Moderna’s Stephane Bancel noted that technology transfers are a “matter of trust – trust between the partners but also patient trust: 70% of vaccine manufacturing is about quality control and quality assurance.” 

“That is why we should not get lost into thinking that intellectual property is the bottleneck. The limiting step is manufacturing know-how and capacity, ability to find skilled workers who can take part in the complex manufacturing process, as well as the raw materials.”

“Basically companies have the responsibility for the quality of their products….Companies really need to have the ability to pick their partners on the basis of checklists, which is really about quality, quality, quality…”

RDIF’s Has Little To Lose from Open Approach 

The Sputnik V vaccine uses twenty-year-old adenovirus technology, which lacks substantial intellectual property protections

In fact, the RDIF has significant built-in incentives to try the open license approach – which western manufacturers may often lack, Knowledge Ecology International’s Director James Love told Health Policy Watch.

“The RDIF lacks significant manufacturing capacity, does not think it is protecting a highly proprietary manufacturing platform, and sees a political benefit if having its vaccine being used,” emphasized Love.

That is in contrast to companies such as Pfizer, Moderna, and other vaccine front runners, which already have significant manufacturing capacity – as well as novel technologies that they wish to protect, he said.  

And RDIF’s open license approach clearly has its limits as well. For example, the company has not shared its vaccine recipe to the WHO-backed COVID-19 Technology Access Pool (C-TAP), Love noted. Even though C-TAP was launched over a year ago, it remains empty to date of vaccine recipes from pharma developers in east or west, north or south.

The RDIF also has given no signal, to date, about whether it would join the WHO co-sponsored global COVAX facility should its vaccine finally be approved by the WHO.  

“I don’t think the RDIF has suddenly become cuddly and philanthropic,” added Jones. “They want the hard currency the sales will bring…I think they also want to demonstrate that they can be a world player in the vaccine business [to become] a more permanent global supplier.”

“Had they [Russia] invented a novel technology, it is not clear to me their current stance would have been taken.”

-Elaine Ruth Fletcher contributed to this story.

Image Credits: RDIF, Stelis BioSource, Wikimedia Commons.

WHO Director-General Dr Tedros Adhanom Ghebreyesus

In his most explicit appeal to date, WHO’s Director General Dr Tedros Adhanom Ghebreyesus called upon the global leaders in COVID mRNA vaccine manufacturing – Pfizer/BioNTech and Moderna to “share their know-how” in vaccine manufacturing with more manufacturers, particularly in low- and middle-income countries. 

The WHO DG also called upon countries that are beginning to issue COVID passports for travel, to recognize any WHO-approved vaccine – a thinly veiled jab at the brand new European Union COVID digital pass, which has been widely criticized for only recognizing vaccines approved by the European Medicines Agency – and not WHO-approved vaccines produced in India, China, or Korea.   

“New manufacturing hubs – including for mRNA vaccines – are being developed,” said the WHO Director General, in a clear reference to a recently-announced WHO mRNA manufacturing hub initiative, to be anchored in South Africa.  “but this could be accelerated by companies openly sharing technology and know-how.   

“In particular, I urge those companies – BioNTech, Pfizer and Moderna – to share their know how so that we can speed up the development of new production.

“The sooner we start building more vaccine hubs and upping global vaccine capacity, the sooner we can diminish deadly surges,” he said, saying that the world is in a “very dangerous period of this pandemic” – and “no country is out of the woods yet.”   

Dangerous Delta Variant Continuing to Evolve 

His appeal came as the Delta variant continues to spread across the globe, detected in at least 98 countries so far, according to WHO. 

Africa, which had escaped more easily from previous pandemic waves is now facing a  sharp increase in new cases, with infection rates climbing faster than previous waves, and “new, and and faster spreading variants fuelling the continents surging third wave,” in the words of a WHO African region briefing on Thursday.  For the first time since the beginning of the pandemic, infection rates in African countries are well outpacing those of India, Latin America or higher income Americas or Europe – where the virus had rampaged last year. 

“In those countries with low vaccination coverage, terrible scenes of hospitals overflowing are again becoming the norm,” said Tedros at Friday’s global update.  “But no country is out of the woods yet. 

“The Delta variant is dangerous and is continuing to evolve and mutate, which requires constant evaluation and careful adjustment of the public health response.”

The WHO also called out rich countries for failing to share enough vaccines – saying that sharing so far has been  “still only a trickle, which is being outpaced by variants. 

And he urged global leaders to ensure that at least 10% of people in every country are vaccinated by the end of September – building up to 70% of the world’s population by the same time next year. 

“By the end of this September, we’re calling on leaders to vaccinate at least 10% of people in all countries,” he said. “This would protect health workers and those at most risk, effectively ending the acute stage of the pandemic and saving a lot of lives.

“It is within the collective power of a few countries to step up and ensure that vaccines are shared, manufacturing is increased and that the funds are in place to purchase the tools needed.”

Calls on Countries to Accept All WHO Approved Vaccines for Travel Certificates 

In a thinly-veiled reference to the new European Union COVID digital pass, the Director General also called upon all countries to recognize all vaccines that have been approved by WHO for their digital certificate programmes. 

The EU pass has been widely criticized in Africa and other developing regions for failing to recognize AstraZeneca vaccines produced by the Serum Institute of India as part of its digital pass programme. 

“Some countries, regions, have launched so called vaccine certificates and I want to make it very clear that it is important that these do not lead to discrimination against those people and countries that have either a lack of vaccines or certain type of vaccine,” Tedros said. .

“As you know WHO issues Emergency Use Listings for vaccines based on a stringent assessment of safety and efficacy and we expect all countries to recognise and accept those vaccines that WHO has approved.”

The EU COVID pass automatically recognizes EMA approved vaccines, which include those by Pfizer, Moderna, Johnson&Johnson, and the European-manufactured version of the AstraZeneca vaccine, known as  Vaxzevria.  But the COVID pass programme excludes two other WHO-approved versions of the same AstraZeneca vaccine manufactured in Korea and India, which has been the main vaccine distributed by the WHO Co-sponsored global COVAX facility, along with the WHO approved Chinese vaccines produced by Sinopharm and Sinovac. Altogether, those vaccines constitute the main options available in developing countries today. 

Travelers “Not a Priority” for COVID Testing. 

Joachim Hombach, Head of the WHO SAGE Secretariat, which provides expert advise on vaccines and realted policies at Friday’s briefing.

In new guidance on COVID-related travel policies, also issued Friday, WHO, however, maintained its previous staunch overall opposition to requiring proof of vaccination at all as a condition for international travel.

“WHO recommends that Member States: not require proof of COVD-19 vaccination as a mandatory condition for entry to or exit from a country,” said the policy brief.

The WHO brief also stated that international travelers should not be treated  “as a priority group for SARS-CoV-2 testing, as they are not suspected COVID-19 cases by default.” 

Even so, the brief recommended that countries consider lifting their testing and quarantine requirements for international travelers who are fully vaccinated with a WHO-approved vaccine or have recovered from COVID-19 within the previous six months, and are no longer infectious.  

And for people that have been vaccinated, countries should “consider recording proof of COVID-19 vaccination in the International Certificate of Vaccination or Prophylaxis (ICVP),” which is recognized globally under International Health Regulations. 

WHO’s Longtime Opposition to Travel Restrictions

Despite the almost universal implementation of COVID related-travel restrictions since the pandemic’s early days of the pandemic, as a means of controlling infection spread, and more recently the spread of variants, WHO has maintained a highly negative stance against any travel limits at all. 

An earlier, December 2020, WHO recommendation advised countries that wish to create travel restrictions, to consider limiting the entry of travelers only in cases where infection rates in the originating countries were significantly higher than at the country of arrival. 

And even that measure might not be necessary if travel volumes are not very high, the brief stated.  

“In most countries, arriving travellers represent a small proportion of the population at any given time,” the brief stated. “Consequently, even if travellers from some countries present a significantly higher infection risk than the domestic population, the overall level of transmission will be elevated only slightly if high incidence is already present in the arrival country.” 

The advice has contrasted sharply with infection models that reflect how international air travel became a key vector for the spread of the SARS-CoV2 virus, from the early days of its emergence.  

Asked by Health Policy Watch what is the logic of discouraging travel-related COVID testing, particularly in low-resourced settings that have widely adopted the procedure, specifically to control the dangerous importation of cases or variants, WHO did not respond. 

 

 

cuba biden
The Biden administration has been asked to clarify its sanctions policy vis a vis Cuba, with respect to COVID vaccines.

The Biden administration has been asked to clarify that sanctions against Cuba would not extend to collaborations in the development, manufacturing, distribution and sale of COVID-19 vaccines that the island nation is in the process of developing.

A memorandum, sent by Knowledge Ecology International (KEI) on 28 June to the White House, asks the US government to “clear the air” regarding its economic sanctions policies – and thus ensure that private companies and other organizations can work with Cuba on its vaccine programme. 

“Over the past year and a half, U.S. sanctions against Cuba have cast a cloud over the ability of companies and non-profit organizations to work with Cuba on its vaccine program. The Biden administration needs to clear the air and reassure the WHO, suppliers of inputs, and others that none of the U.S. sanctions against Cuba extend to activities to make, sell or distribute its vaccines,” said KEI Director James Love in his memo.  

The ongoing economic blockade of Cuba during the pandemic was described by Argentina’s President Alberto Fernandez, as “obscene” in his closing remarks to the 74th World Health Assembly (WHA) in May. He called for it to be lifted – alongside the removal of patent protections for COVID vaccines. 

Cuba scientists are facing challenges in the development and scale-up of the manufacture of their vaccine candidates, which have been reported to have significant potential, due to restrictions imposed by the longtime US economic sanctions against the communist island state. 

Cuba’s Vaccines in Late Stages of R&D; Abdala Vaccine 92% Effective Against Coronavirus 

Cuba’s COVID-19 vaccines are seen as Latin America’s hope.

Despite ongoing challenges, Cuba is in its late stages of research and development with two out of five of its indigenous COVID-19 vaccines – Abdala and Soberana 2.  

On 21 June, Cuba announced that its three dose Abdala vaccine against COVID-19 was 92% effective. Earlier, it said that its Soberana 2 vaccine was 62% effective with two doses, with its efficacy expected to rise with administration of the third dose.  

“This is excellent news and fills us with optimism in the region, where there is still a great deficit of vaccines,” said Jose Moya, WHO Pan American Health Organization (PAHO) representative in Cuba as quoted by El Pais. 

Once trial data is published, Cuba will then file for regulatory approval with its national medicines authority.  Health officials meanwhile aim to have 70% of the island’s inhabitants vaccinated by this fall.  

The Cuban government is also in the process of engaging the WHO in the evaluation of its vaccine candidates, for WHo regulatory approval.

“If all goes well, the Cuban vaccines will be able to join the eight already prequalified in the world before the end of the year,” Moya added.

Cuban Vaccines – Potential Importance to Latin America

These announcements could mean good news for neigehboring Latin American states, which have been unable to access sufficient vaccines from big suppliers in the US, Europe, India, China, or Russia – even as Latin America has been the global epicenter of the pandemic in recent weeks.

PAHO has meanwhile called for urgent donations of vaccines in light of the growing spread of COVID in Latin America and the Caribbean, also uging G7 nations to expedite delivery of promised donations, especially since vaccine rollouts have progressed more slowly than hoped-for in Latin America.   At a recent meeting in the United Kingdom, the Group of Seven (G7) pledged one billion COVID vaccine doses to countries around the world,

Calls on US to Support Evaluation and Registration of Cuba’s Vaccines 

The KEI letter also asked that the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), and other federal agencies directly engage with Cuban research institutes to fund expanded or additional clinical trials, and support them in achieving global regulatory approval.  

Love cites a 13 June 2016 Memorandum of Understanding between the US Department of Health and Human Services and the Ministry of Public Health of Cuba, which called for deepening public health cooperation on communicable diseases – understandings put in place during the administration of former US President Barack Obama  – but frozen during the term of US President Donald Trump. 

The KEI letter also refers  to a January White House memorandum published in January, just after President Joe Biden took office, outlining COVID-related sanctions relief measures that it would take. That memorandum states: 

“The Secretary of State, the Secretary of the Treasury, and the Secretary of Commerce, in consultation with the Secretary of HHS and the Administrator of USAID, shall promptly review existing United States and multilateral financial and economic sanctions to evaluate whether they are unduly hindering responses to the COVID-19 pandemic, and provide recommendations to the President, through the APNSA and the COVID-19 Response Coordinator, for any changes in approach.”

Despite this statement, Biden’s campaign promises to “go back” to the Obama policy of engagement with Cuba remains unfulfilled, with the US currently focused on its own interests, a senior administration official was recently quoted as saying by the Washington Post.

“We have an entire world and a region in disarray,” the official said, speaking on the condition of anonymity. “We are combating a pandemic and dealing with a breaking down of democracy in a whole host of countries. That is the environment we are in. When it comes down to Cuba, we’ll do what’s in the national security interest of the United States.”

Image Credits: News Prensa Latina/Twitter, C-Span.

Before the world was hit by the COVID-19 pandemic, humanity’s deadliest infectious disease was a different respiratory illness, one that we have lived with for millennia: tuberculosis (TB). Vaccines developed and rolled out in record time are already driving a reduction in deaths due to COVID-19. Meanwhile, the outlook for TB remains dark: 4,000 people continue to die of the disease every day, including 700 children. And that curve isn’t budging. Good news in the world of TB has been in short supply this year. In fact, recent research has shown that the countries that bear the biggest TB burdens saw a drastic decrease in TB diagnosis and treatment after COVID-19 hit in late 2019. In just 18 months, the Covid pandemic and the measures taken to address it erased some 12 years of significant and measurable progress against TB. This is bad news for us all. 

Last month though, the adoption at the United Nations General Assembly High-Level Meeting (UNHLM) on AIDS of an ambitious declaration to end HIV by 2030, gave me a glimmer of hope. TB, which is the primary cause of death for people living with HIV, featured prominently in the declaration, which called for expanding access to the latest technologies for TB prevention, screening, diagnosis, treatment, and vaccination. Member States also agreed to ensure that 90% of people living with HIV receive preventive treatment for TB, and they vowed to reduce AIDS-related TB deaths by 80% by 2025. If these targets are met, and I believe they can, we’ll be moving closer to the commitments made at the 2018 UNHLM on TB. Importantly, in the political declaration member states also renewed their commitment to host a second UNHLM on TB in 2023. 

COVID-19 and the Perspective of Ending TB and HIV by 2030

HIV and TB patients face significant new barriers to access care in the COVID pandemic era.

TB and HIV are tragically interlinked, especially in the African region. The risk of developing TB is estimated to be up to 27 times greater for people living with HIV than among those without an HIV infection. In 2019, roughly 9% of all TB cases worldwide occurred among people living with HIV. Nearly half of people affected by TB were neither diagnosed nor treated, which is one of the reasons why, according to the World Health Organization (WHO), roughly one third of all AIDS deaths are caused by TB. 

Even before COVID-19 hit, the world was not on track to meet either our HIV or TB commitments and targets. Last year, UNAIDS announced that missed targets had resulted in 3.5 million more HIV infections and 820,000 more AIDS-related deaths since 2015 than would have been the case had targets been met. Similarly, a WHO report issued in September 2020 found that despite progress in the fight against TB, ‘urgent and more ambitious investments and actions are required to put the world on track to reach targets.’ In 2018-19, for example, 14.1 million people were treated for TB, against a target of 40 million between 2018-2022. 

With COVID-19, the public health challenges grew more complicated than ever. Neither TB nor HIV went anywhere when the pandemic hit, yet the attention they receive decreased. Doctors and nurses were redirected, public health officials’ attention was diverted, and many health systems soon became overwhelmed. Meanwhile, people with active TB infections have remained more vulnerable to COVID-19 and other illnesses because their lungs are already damaged. In addition, people affected by TB also run a greater risk of developing complications from COVID-19. 

How COVID-19 Can Help TB and HIV Responses  

National TB Centre, Abovian, Armenia. Dr Shahidul Islam, an MSF TB doctor, examines a patient on the DR TB ward in the national TB centre.

To be sure, we still have a long way to go on COVID-19. We need to ensure equitable and affordable access to vaccines, diagnosis, and treatment, recover from the pandemic, prepare for the next airborne pandemic and, at the same time, win back lost progress against TB and other diseases, including the lost ground on protecting the right to health. The good news is that the important lessons that we have learned in the fight to end TB can inform our response to COVID-19—and vice versa. Indeed, carefully thought out and forward-looking interventions for prevention and care of airborne respiratory infections will benefit the fight against both COVID-19 and TB, as well as any future pandemic arising from an airborne infectious disease. 

We already know what the most effective policies look like. They include massive community and primary health-care level screening and contact tracing. People with a cough and fever should be tested for both TB and COVID-19, using the latest laboratory tests and imaging techniques. For this to happen at scale, all primary health care units will need to be equipped with diagnostic tools and mobile vans that can visit communities directly. Community workers—who are properly equipped, trained, and remunerated—should also conduct contact tracing and actively screen vulnerable populations in at-risk and hard-to-reach communities. 

We also need to take steps to control the spread of airborne infections in healthcare facilities and in any other places that people gather. These include measures like ventilation, ultraviolet irradiation, personal protective equipment, and more. And we need to combine real-time surveillance data with early warning systems so that public health officials have the tools they need to make agile, data-driven decisions as they respond to outbreaks. The experience and expertise of TB programs in all of these areas will be of great benefit in countering COVID-19, and all airborne infectious diseases.

I’m convinced that such efforts will succeed if they are backed by proper resources and political leadership, and if we continue to insist that COVID-19 outreach and prevention efforts include TB work, instead of replacing it. The global health community must also remember that those groups of people who are vulnerable to TB are in many instances also among the world’s most marginalized. TB is therefore a social challenge that demands an unwavering commitment to principles of social justice. As TB affected communities reminded us last year, there is a deadly divide between TB commitments and TB realities, but today we have a significant opportunity to leverage investments in COVID-19 to end TB.

The UNHLM on AIDS declaration is ambitious, and it sets out a clear path for a coordinated response to HIV/AIDS and TB, within the context of COVID-19. It also represents a strong message from world leaders that people living with HIV/AIDS and TB will not be left behind as the world continues to focus on the COVID-19 response. The past year has shown us what can be achieved with the right political will and resources, and I’m optimistic that we can do the same for TB and HIV.

Dr Lucica Ditiu

But a declaration is one thing, action is quite another. That’s why we at the Stop TB Partnership are calling on Member States to follow through on their promises. And we stand ready to work in partnership with them to fulfil their commitments, and to fight to end HIV/AIDS and TB by 2030. 

Looking ahead to 2023, I look forward to fully engaging in the preparation and organization of the next UNHLM on TB, when we will review our progress in eliminating this disease. In the meantime, we will continue to fight for people everywhere who are affected by TB, including people living with HIV—by ensuring they get the care and support they need, and by making their voices heard at the highest levels.

 

Dr Lucica Ditiu, Executive Director of the Stop TB Partnership, a UN-hosted entity based in Geneva that’s committed to ending TB by 2030, is an accomplished professional and leader in the global fight against tuberculosis (TB) and other communicable diseases. 

Image Credits: Nick Youngson, End TB.