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.

Rwanda
COVAX made promises of 700 million doses but delivered 30-40 million, says African Union Special Envoy.

The African Union (AU) Special Envoy on COVID-19 has bluntly blamed the WHO co-sponsored COVAX facility for the dire vaccine shortage on the continent, saying that it had failed to disclose its vaccine supply problems early enough.

Strive Masiyiwa, AU Special Envoy and head of the African COVID-19 Vaccine Acquisition Task Team (AVATT) said that had COVAX been honest about its lack of vaccine supplies at the start of the year, the continent might not be facing such a dire shortage of vaccines.

When AVATT met COVAX “back in January”, said Masiyiwa, “we were given a schedule in writing that we would receive vaccines from the end of February, going through to December”.

“But COVAX failed to disclose that they were still trying to get money, that pledges [of $8.2 billion] which had been made by certain donors had not been met,” said Masiyiwa, in his most forthright condemnation of the global vaccine platform yet.

“That’s pretty material information. Had we known that actually this was hope and not reality, we may have acted very differently,” Masiyiwa told the Africa CDC weekly COVID briefing on Thursday, which also disclosed that AVATT had procured 400 million COVID-19 single-dose vaccines from Johnson & Johnson that will start to arrive next month.

Early Indications that Serum Institute of India Could Not Deliver

Strive Masiyiwa, African Union Special Envoy and head of the AU COVID-19 Vaccine Acquisition Task Team (AVATT)

He also questioned the global vaccine programme’s reliance on the Serum Institute of India (SII), revealing that AVATT had met with the SII late in 2020 – well before India’s COVID crisis – and decided not to do business with it because it was clear it would be unable to meet its orders.

“We found ourselves in March, scrambling. Now we are told that is India’s problem. And we think the problems are much deeper than that,” said Masiyiwa.

“We will not solve our problem because of donations. We will solve our problem because we’ve gone out and we have bought our vaccines,” he added, disclosing that all but two African countries had secured loans to pay for the AVATT-acquired vaccines.

“The price we pay for any vaccine is exactly the same price as COVAX. I can tell you on this platform because I’ve heard silly rumours. We purchase the Johnson & Johnson vaccine at $7.50 per dose,” he added, saying that AVATT would be “transparent” about vaccine prices.

Masiyiwa said that the Johnson & Johnson order – to be delivered over the course of a year – would cover half the continent’s people, while donors had undertaken to come up with the other half.

“We are moving hard ahead on our commitment. We always said we would start around about August, and the shipments are being prepared. The countries are being prepared. But we are calling on the donor community to stop making pledges, pay up your money and meet the commitments you’ve made. Because we’ve heard the pledges. We just need to see the vaccines now.”

Meanwhile, Kate Elder, Medecins sans Frontieres policy advisor on vaccines, described COVAX as having been “constructed to work within the current parameters of the pharmaceutical market, where you see how much money you can raise and then see what you can negotiate with industry for it”. 

“COVAX was not set up to succeed,” said Elder, speaking shortly before a recent board meeting of the global vaccine body, Gavi, which manages COVAX. “COVAX was left behind as wealthy governments secured their doses through bilateral deals with an industry that acted as expected: selling doses first to the buyers who could afford to pay the most.”

“COVAX is currently grossly behind on achieving its goals. COVAX had aimed to provide two billion doses by the end of 2021, but so far has only distributed 88 million (the goal by the end of June was to distribute around 337 million),” said MSF.

“Less than half of one percent of total populations of COVAX countries have received at least a first dose of vaccine through COVAX. As the global health community increasingly discusses models to be prepared for future pandemics, MSF cautions that the shortcomings of the COVAX model must not be replicated.”

 

Image Credits: WHO.

Dr John Nkengasong, Director, Africa Centres for Disease Control Director

African Union and WHO/African Region officials on Thursday sharply criticized the European Union decision to not grant the Indian version of AstraZeneca’s “Covishield” vaccine, distributed by the global COVAX facility, recognition in the new EU “Digital Green Pass programme” – amidst a growing chorus of global protests over the double standard.

In a related statement, the global COVAX facility, also denounced what it described as  “a two-tier system” of green COVID travel passes, which are “further widening the global vaccine divide and exacerbating the inequalities that we have already seen in the distribution of COVID-19 vaccines.

“Such moves are already undermining confidence in life-saving vaccines that have already been shown to be safe and effective,” said the statement, signed by WHO, UNICEF, GAVI, the Vaccine Alliance, and the Oslo-based CEPI initiative supporting vaccine R&D – without referring specifically to the EU COVID certificate, whose rollout began officially 1 July.  In a separate comment to Health Policy Watch, WHO said that it remains opposed to vaccine passes altogether for international travel until COVID vaccines become “universally available”. Added the WHO spokesperson, “WHO recommends that the same rules should apply for all individuals” who have received any vaccine with a WHO Emergency Use Authorization, “with no difference in restrictions depending on the product.”

Meanwhile, at an African Centres for Disease Control press conference, officials said that the first shipment of some 80 milion US-donated J&J vaccines is just  “days” away from reaching the continent. Africa will pivot even more sharply away from Covishield, the AstraZeneca vaccine produced by the Serum Institute of India (SII), and towards the Johnson & Johnson one-shot alternative in coming months – with a new deal to procure some 400 million J&J doses produced by the South Africa-based Aspen Pharmacare, due to begin deliveries in August.   

Disappointment with COVAX – Hope from J&J Alternative

Strive Masiyiwa, African Union Special Envoy and coordinator of the African Vaccine Acquisition Task Team (AVATT)

Strive Masiyiwa, African Union Special Envoy and coordinator of the African Vaccine Acquisition Task Team (AVATT), told journalists that the pivot away from Covishield is due to the ongoing inability of SII and COVAX to meet the promised timeline for the delivery of the doses. 

“COVAX told us in January that they will deliver 700 million doses by December, at a rate of 14 million doses a month. You don’t need me to tell you that that hasn’t happened. To date, less than 15 million doses have arrived,” he said. (see related Health Policy Watch story)

But the identification of an intra-Africa vaccine production opportunity also has raised hopes.  A recent deal between J&J and the South Africa-based Aspen Pharmacare sets out a roadmap for the expanded manufacture of the single-dose J&J vaccine destined for the African market.

“We have entered into an agreement to purchase 400 million single dose vaccines, just enough to cover 400 million people as they’re not double-dose vaccines. They are manufactured by Johnson and Johnson,” Masiyiwa said.

So far over 50 member countries of the African Union  have joined, and made orders for shares of the 400 million J&J vaccine doses produced by Aspen, due to begin delivery in August.

First Shipments of US Donations Days Away from Getting to Africa 

Meanwhile, in a race against growing infection rates on the continent, the first shipments of US donations of some 80 million vaccines are now only days away from getting to the first African countries, Masiyiwa said.

He commended the new US government for stepping up quickly to the bat.  

“The first US shipments in support of their donations will begin next week to 51 African countries. And they do include Johnson and Johnson and Pfizer vaccines, because these are United States vaccine manufacturers,” he stressed. 

At a separate briefing, Gayle E. Smith, US State Department Coordinator for Global COVID-19 Response and Health Security, said vaccines and the urgency of vaccine delivery is at the top of the US government’s agenda for the continent of Africa. 

“President Biden has announced that we are sharing 80 million vaccine doses from our own supply, and we will be sharing more.  Those vaccines are now in the process of delivery to various countries and will continue to roll out over the coming days and weeks.  The President also announced just prior to the G7 summit that the United States is purchasing and will donate 500 million doses of the Pfizer vaccine,” Smith added.

Those donations are being financed through a US$4-billion donation from the US government, and will be channeled through COVAX for distribution in the second half of 2021 and beginning of 2022.  

EU Policy – ‘Not Based on Science or Data’  

The European digital green pass

The European Union (EU) on the other hand, was coming under fire for both failing to share vaccines as well as failing to recognize Covishield, the most widely-used COVID-19 vaccine in Africa, in the EU-wide COVID digital pass programme, which began rollout 1 July.  

In a statement, Africa CDC “noted with concern recent communications regarding the applicability of the EU Digital COVID Certificate “Green Pass” to different COVID-19 vaccines….

“The current applicability guidelines put at risk the equitable treatment of persons having received their vaccines in countries profiting from the EU-supported COVAX Facility, including the majority of the African Union (AU) Member States,” added the Africa CDC statement: 

“These developments are concerning given that the Covidshield vaccine has been the backbone of the EU-supported COVAX contributions to the AU Member States’ vaccination programmes.” 

At Thursday’s Africa CDC briefing, Director Dr John Nkengasong stressed that the EU’s decision on Covishield was ‘not based on science or data’, noting that the AstraZeneca Covishield vaccine produces very high neutralizing antibodies – and in any case is also a biosimilar of the Vaxzevria version of the vaccine, produced by AstraZeneca in Europe.  

“If they were producing less quality neutralizing antibodies, they’ll probably argue based on that, the vaccine was not fit to be recognized,” he added, wryly.

WHO representative in Ghana, Francis Kasolo, on left, with UNICEF’s representative, Anne-Claire Dufay as first COVAX vaccine doses to reach Africa arrive on 24 February in Accra, Ghana,  While the deliveries were met with much diplomatic hoopla – formal recognition of the vaccines in Europe has not followed suit.

He enjoined the EU to reverse policy actions that could also sow doubts in the minds of Africans about the validity of vaccines they receive, worsening vaccine hesitancy on the continent.

“We are really calling on the European Union to stay away from such policies that will undermine efforts and make it difficult for us to fight this pandemic, which is a serious pandemic,” he said.

“I was at the airport, together with the head of the European delegation at the African Union, receiving the [first] COVAX vaccines from India that fateful morning, very early in the morning at 6 a.m,” Nkengasong recalled. “So for them to turn around and say they will not recognize the vaccine is very troublesome, and we hope they will reverse that condition very quickly,” (See related Health Policy Watch update on EU Policy).

Europe Faces a Choice: Watching Football without Masks – or Sell & Share Vaccine Doses with Africa

Beyond the bottlenecks created by the vaccine passport, Masiyiwa also accused the EU of not playing a sufficiently active role in supporting Africa in the continent’s COVID-19 vaccination plans, with vaccine doses.

“The EU has vaccine factories and vaccine production centers across Europe. Not a single dose, not one vial, has left a European factory for Africa. We’ve gone to talk to them and they told us that they are completely maxed out,” Masiyiwa revealed.

He noted that while countries in the EU have vaccinated sufficient numbers of people so that venues like football stadiums are now reopening to people without even wearing masks, Africa still lacks vaccines even for the highest priority risk groups.  

“Europe has to decide. You can’t say you support us while less than 1% of our population has been vaccinated but they can now watch football without masks. That is just the facts,” he said.

“Now is the time for Europe to open up its production facilities so that we can buy vaccines. We are not asking for donations. The fact is that we have money to buy vaccines. Vaccines are not expensive. When it comes to the minds of our people, the poorest of the poor African countries have all stepped forward and paved the way for us to buy vaccines. But we need those European factories in the Netherlands, Belgium, Italy; they must open them up and sell vaccines. We don’t even ask anyone for donations.”

Reassuring Evidence that Vaccine Mix & Match Boosts Immunity

Richard Mihigo, Immunisation and Vaccines Development Programme Coordinator at WHO’s Regional Office for Africa.

The AU shift to the J&J vaccine comes against the background of reassuring new evidence that mixing Astrazeneca and Pfizer vaccines could boost immunity, both African CDC and WHO officials also added.

“It really produces a very strong reaction, a positive immunological reaction so yes, you can definitely do that,” Nkengasong told Health Policy Watch. “So I think with a shortage, studies now conducted in laboratories and clinical trials have shown that we can do that as well.”

He described this as a solution to the second dose dilemma faced by most African countries (except Nigeria) where the government decided to use shipments of the Astrazeneca vaccine to provide as many people as possible with one dose – rather than holding supplies for two doses of fewer people. 

So when the J&J vaccines become available, “Those in short supply of the AstraZeneca vaccine can always get the J&J as their second dose,” he added.

His comments were echoed by Richard Mihigo, Immunisation and Vaccines Development Programme Coordinator at WHO’s Regional Office for Africa: “These are rather good news that are starting to emerge, and potentially alleviate the issue we are seeing now with delays in the shipment of the second goes of AstraZeneca vaccines and allowing people to complete their vaccination doses,” Mihigo said.

Vaccine Desperation Replacing Hesitancy as Third Wave Accelerates

Professor Jean-Jacques Muyembe, Director-General of DRC’s National Institute for Biomedical Research

Meanwhile, there were signs that vaccine desperation might be gradually overcoming vaccine hesitation in a couple of key countries, such as the Democratic Republic of Congo (DRC) and Tanzania.

At Thursday’s WHO Afro Region briefing, Professor Jean-Jacques Muyembe, Director-General of DRC’s National Institute for Biomedical Research, said that new pressures on the country’s health system exerted by the third wave of the pandemic is also accelerating interest among DRC health professionals and the public in getting vaccinated – after widespread vaccine hesitancy thwarted the initial phase of the DRC’s vaccine rollout – prompting the country to return about 1.3 million doses it had received in April.  

Now, with COVID-19 cases, hospitalisation and deaths surging across the country, Muyembe said more people are now asking for the vaccines – although tragically doses are virtually unavailable even as the third COVID wave, driven by the Delta variant that was first identified in India, sweeps over the country.

“As we speak today, this Indian (Delta) variant represents 84% of the variants that are circulating in DRC,” Muyembe said.

In Tanzania, as well, the new government has recently expressed interest in joining the WHO COVAX facility, as well as reportedly budgeting some US$ 470 million to purchase COVID-19 vaccines.  For the first time in over a year, Tanzania this week also reported data on new COVID infections – more regular reporting of COVID data had been stated as an International Monetary Fund condition for consideration of a a US$ 574 mllion loan request by the country to finance its belated COVID response.

 

 

Image Credits: Algorithm Watch.

In Portugal, where all illicit drugs are decriminalized, drug disorders claim the lives of just 0.8 in 100,000 people, a figure that pales in comparison to Brazil, the Philippines – or even the US where the death toll stands at a staggering 18.75 in 100,000 people, or 23 times higher than Portugal.

High death tolls, experts say, are largely preventable through policies rooted in robust evidence and human-rights, yet their adoption remains lackluster from north to south.

Carl Hart, Professor of Psychology at Columbia University and drug advocate

“Drug policy can be done better if we had a desire,” said Carl Hart, Professor of Psychology at Columbia University. “There are great models around the world, if only we cared enough to observe those models and learn from those models.”

“Portugal has decriminalized all drugs. They’re not arresting people for what they put in their bodies. People are allowed a 10-day supply of drugs without fearing criminal prosecution.” 

He was speaking last week on the eve of International Day Against Drug Abuse and Illicit Trafficking, at a panel hosted by the Graduate Institute’s Global Health Centre on the global day of action for the grassroots Support Don’t Punish campaign.

“I am advocating for the legal regulation of drugs,” stressed Hart. “If we legally regulate those drugs, we increase the safety of that activity.” 

“We as a society should invest in people, and not investigate what substance people are ingesting. That isn’t our business.”

His comments come on the heels of a shocking US CDC report that reveals overdose-related deaths in the US increased by nearly 30% between November 2019 and 2020 with over 90,000 deaths during this period, almost double the death toll in 2015.

Aside from the millions of lives that drugs claim every year, drug-related health issues account for 5.5 % of all Disability Adjusted Life Years (DALYs). That equates to 131 million healthy years of life lost due to ill-health and lifelong disability.

Drug overdose deaths in the US rose by nearly 30% between November 2019 and 2020

Drug Problems Relate to Prohibitive, Stigmatizing Policies 

Rather than drugs themselves, prohibitive and stigmatizing drug policies result in unnecessary incarcerations, murder, and the arrest of one American every 25 seconds, or 1.5 million Americans a year.

“Most of the problems related to drugs are related to prohibition,” stressed Hart. “All of these people in jail, all of this murder, all of these horrible things that are often promulgated by the state itself – reverse these policies and then you will deal with a lot of that carnage.”

If drugs were regulated rather than prohibited, a million Americans a year wouldn’t go to jail, he added.

If countries decide to opt for legalization, regulation, and other smart drug policies, thousands of potentially lethal overdoses and accidents could be avoided, said Hart, mainly due to illicit drugs that are more potent than users think and can be spiked with potentially lethal contaminants.

“If we legally regulate those drugs, we increase the safety of that activity, we make sure that those drugs are not tainted with potentially harmful substances and we can control who is allowed to purchase those substances.”

About a fifth of illicit drugs are laced with contaminants that users did not intend to take, surveys from New Zealand and England have found, sometimes with potentially deadly heavy metals, bath salts, or even horse tranquilizers. 

Studies, mainly from New Zealand and England, indicate that cheap policies, like drug-testing programmes at parties and festivals, could prevent drug users from taking contaminated drugs bought on the illicit market.

According to one study of a drug-testing programme at a four-day festival in the UK, drug-related hospitalizations dropped by 95% the year it was introduced. One-fifth of festival attendees used the free testing service, and one-fifth of drugs were contaminated. Strikingly, two thirds of attendees’ whose drugs were contaminated disposed of these drugs. These results suggest that screening programmes have potential to prevent drug users from taking contaminated drugs bought on the illicit market – and to reduce drug-related injuries, deaths, and drug consumption as a result.

Legalizing drugs could also reduce the appetite for synthetics like fentanyl, an opiate that is 50-100 times more potent than morphine, whose rising consumption has been fuelled by the pharmaceutical industry, regulatory failures, but also scarce access to heroin, said Hart.

“There is not a real need for illicit fentanyl,” he said, emphasizing that fentanyl consumption could be reduced if drug users had access to heroin – an opiate they prefer.

“Most heroin users would much prefer heroin to fentanyl, for a number of reasons: the euphoria, in my view, is better with heroin…Heroin is relatively short-acting [and] the hangover effects are minimized.”

In the US, 36 out of 50 states have legalized cannabis products for medical conditions from severe forms of epilepsy, back pain, to nausea and vomiting during chemotherapy. 

And a wealth of studies have revealed that US states who legalized cannabis saw sharp drops in violent crime, fatal traffic accidents, opioid use and opioid overdoses – without leading to a spike in teenage cannabis consumption. 

Last December, the UN Office on Narcotic Drugs recommended that countries remove cannabis from the “most dangerous” list. 

Switzerland’s Forward-Looking Policies to Address Illegal Drug Trafficking

Should drugs be legalized, policies will need to target low-income groups and young people, especially those who face mental health issues or violence, as they are most at risk from harm as a result of taking drugs, Thomas Zeltner, Chair of the Swiss Research Institute for Public Health and Addiction, told Health Policy Watch in an interview.

Thomas Zeltner, Chair of the Swiss Research Institute for Public Health and Addiction

One way to do that, he explained, is through targeted screening programmes in those groups – instead of screening whole populations.

“Only 1 in 20 kids or young people who use drugs will develop drug issues. And many of those who develop issues are children from divorced single mothers, children who have difficulties in school reading difficulties, and children with pre-existing mental health problems,” he said, adding that the consumption of drugs like cocaine tends to lead to few problems in rich people, at least in Switzerland.

“We’ve done quite a number of studies and shown that giving vulnerable kids intensive support is much smarter than to spend the money on targeting all the kids in a class.”

Once upon a time, Switzerland’s approach on drugs used to be “amazingly open” and evidence-based, emphasized Zeltner.

In the late 90’s, the sale and cultivation of the cannabis plant was legal in the Alpine nation, including plants with the so-called “Tetrahydrocannabinol” (THC) compound that is known to trigger a “high”. That policy, he says, helped cut illegal drug trafficking as well as criminal and social problems.

“In the 80’s and 90’s, 100% of the cannabis market was in the hands of North Africans. Many of them were here illegally, and many of them had no other opportunity than to deal with cannabis. And so we had a lot of criminal and social problems.” 

“But after the Swiss authorities allowed shops to sell cannabis and to grow their own plants to satisfy their needs, what happened was that the cannabis market moved from North Africans to Switzerland, criminality went down and social problems went down.”

Switzerland, added Zeltner, is also well known to have spearheaded research that was ahead of its time, leading to substantial benefits in drug users who did not respond to methadone – an oral drug that is still commonly used for opioid dependence.

“We saw that there were many drug users in the 80’s and 90’s,” emphasized Zeltner. “We could not offer a treatment with methadone, which is the standard treatment for drug-using persons who want to get into treatment but cannot abstain from taking substances, because there were people who actually needed to inject drugs.”

In the mid-90’s, Swiss researchers designed a landmark double-blind trial to address that. Strikingly, the Zurich-based trial revealed that addicts could distinguish between heroin and morphine – and that small doses of heroin were more effective than morphine in treating addicts.

“The results from the double-blind clinical trial in Zurich were clear,” he said. “Drug users could feel the difference between heroin and morphine, even though pharmacologists will tell you ‘that’s not possible’, which was a very interesting finding.”

Those results, said Zeltner, led to a groundbreaking shift in Swiss policy that would eventually position heroin as a standard treatment option for drug users in the country. Today, almost 10% of people with opioid dependence are prescribed heroin in Switzerland –  a unique policy that has only been adopted in a few countries to date, despite robust evidence that it works.

“Heroin is actually a standard treatment in Switzerland,” said Zeltner. “We are one of the very few countries where heroin prescription for drug users is legally allowed and is part of our legal drug policy.”

“At least in the 90s, there was an amazing openness to try evidence-based policies to say – listen, if we want to make a further step forward, we just need to pilot new ideas.” 

Growing Conservatism has Reversed Evidence-Based Policy

In Switzerland, cannabis is considered illegal if its THC content is above 1%

In past decades, however, conservative political winds have reversed Switzerland’s open and evidence-based approach to drug policy, warned Zeltner.

“It used to be possible in Switzerland to have scientific-driven discussions, but this has not been the case in the country,” he said.

He was referring to Switzerland’s current cannabis policy, which considers any cannabis product illegal if its THC content is above 1%.

While that drug policy is progressive in some ways, it has failed to resolve illicit cannabis trade, and reflects increasingly rigid views on drugs that have hampered progress in drug rehabilitation programs, Zeltner said. Cannabis, according to the Federal Office of Public Health, is still the most commonly used illicit drug in the country.

“It’s evident that a large number of people in Switzerland are still buying and smoking illict cannabis with a high THC content,” he said. “These days, it is very hard to get through and we should really get back to evidence-based policy.”

Image Credits: Felix Brönnimann, Wikipedia, US CDC.