Pfizer’s COVID-19 vaccine during the manufacturing process.

The contribution COVID-19 vaccines can make to beating the pandemic will depend on the extent to which they are produced at scale, priced affordably, and deployed globally, says the first peer reviewed study on equitable access to vaccines, published in The Lancet on Friday. 

The Lancet article comes in the wake of a joint appeal by WHO and UNICEF for governments to share vaccines through the WHO co-sponsored COVAX facility, and for vaccine manufacturers to maximise production and transfer technology to help scale up the global supply of vaccines. 

In The Lancet study, researchers from universities and research centres in the United Kingdom, the United States, Thailand and Singapore evaluated the potential global contributions of each of the 26 leading vaccine candidates, scoring them based on their potential role in achieving global herd immunity.

“Several manufacturers have successfully developed COVID-19 vaccines in under 12 months, an extraordinary achievement. But the stark reality is that the world now needs more doses of COVID-19 vaccines than any other vaccine in history in order to immunise enough people to achieve global vaccine immunity,” said Olivier Wouters, lead author of the study and assistant professor at the London School of Economics and Political Science, in a press release.

“Unless vaccines are distributed more equitably, it could be years before the coronavirus is brought under control at a global level. The questions now are when these vaccines will become available, and at what price,” he added. 

The 26 vaccine candidates, several of which are still in development, were scored using a traffic light system. Some 13 of the 26 vaccine candidates got a green light across at least one of the categories of development and production, affordability, allocation and deployment, including vaccine’s produced or in late stage development by Oxford/AstraZeneca, Novavax, Sinopharm/Beijing Institute, and Gamaleya, which is developing Russia’s Sputnik V vaccine. 

Key characteristics of leading vaccine candidates with traffic-light system signalling potential for achieving global vaccine immunity.

Only five of the vaccines reviewed have already been authorised by a stringent regulatory agency. Just five of the vaccines have a supply agreement with COVAX, the WHO-supported a global initiative to procure and equitably distribute vaccines, and only one vaccine, China’s Sinovac vaccine, was assigned a green light for its ease of cold-storage in low-resourced settings.  

Pricing and Accessibility of Vaccines

The pricing of the 26 vaccine candidates varies from US$5 to US$62 per vaccine course. Advanced deals between pharma companies and high-income countries have limited supplies available to low- and middle-income countries, and potentially caused the prices to rise, the study’s authors found. 

“Securing large quantities of vaccines in this way amounts to countries placing widespread vaccination of their own populations ahead of the vaccination of health-care workers and high-risk populations in poorer countries,” said Mark Jit, co-author and professor at the London School of Hygiene & Tropical Medicine. 

“Based on known deals, governments in high-income countries representing 16% of the global population have secured at least 70% of doses available in 2021 from five leading vaccine candidates,” said Jit. 

The COVAX facility is attempting to combat this uneven access to vaccines by securing low prices to vaccines and developing a diversified portfolio for the 190 participating countries, particularly for the 92 low- and middle-income countries eligible for donor-supported vaccine supplies through the Advanced Market Commitment of GAVI, The Vaccine Alliance, which is a key COVAX partner along with WHO and UNICEF. 

“With additional funding, COVAX could compete better in the global scramble for vaccines,” said Wouters, but the global initiative is facing a US$6.8 billion funding gap that needs to be closed to fulfil the goal of delivering two billion doses by the end of 2021.  There is a total US$ 27 bilion funding gap for all arms of the global Act Accelerator Initiative – including tests, treatments and health systems strengthening as well as vaccine rollout. 

In addition to the challenges of basic vaccine affordability and access, many low- and middle-income countries lack the infrastructure needed for vaccination registries and for the storage, delivery and waste management of the vials and syringes, the study notes. 

This is particularly an issue for COVID-19 vaccines that require ultra-cold chain storage and have multiple doses. Single-dose vaccines that only require regular refrigeration temperatures, such as AstraZeneca/Oxford and Novavax vaccines, will likely be preferable in resource-constrained countries – while the Sinovac vaccine, which can be stored at room temperature, has the most modest requirements of all.

The cold chain storage for the Pfizer/BioNTech vaccine at Pfizer’s warehouse in Kalamazoo, Michigan.

“Both globally and nationally, the availability of diversified sets of vaccine options is likely to be needed to bring the global pandemic under control,” stated the study.

A select few vaccine developers have committed to maintain a low price globally for their vaccines during the pandemic, including Oxford/AstraZeneca, Gamaleya, J&J, Novavax, and Bharat/BioNTech, whose vaccine is still in development. 

However, AstraZeneca’s licensees as well as other vaccine developers in India and elsewhere are also making arrangements to sell a portion of their vaccines production on the private market in countries such as India, Bangladesh, and Brazil, raising concerns that private sales in poor countries could further undermine the aim of equitable access.

According to Wouters, “vaccines developed by Chinese, Indian, and Russian manufacturers may…offer a lifeline for the lowest-income nations if they show good results in phase 3 trials, allowing them to procure abundant doses of vaccines that have not yet been authorised in most high-income countries. Once authorised by WHO, these vaccines could also potentially contribute to the COVAX portfolio.”

The vaccines developed by Chinese manufacturers, however, are among the most expensive, with Sinopharm charging US$62 and Sinovac charging US$21 for both doses. It is currently unclear if the companies intend to reduce their prices for low- and middle-income countries.

Challenge of Scaling up Production

Expanding production capacity is a “monumental challenge” at the moment and disruptions in manufacturing have been announced by AstraZeneca, Pfizer, Moderna, and Johnson & Johnson, all of which have delayed initial deliveries of promised doses in Europe, the United States and elsewhere due to production kinks in the initial rollout phases. 

According to the authors of the study, the more widespread transfer of technology, knowledge and data would provide a solution to the production bottleneck. So far, vaccine knowledge sharing efforts, including through WHO’s COVID-19 Technology Access Pool (C-TAP), which calls on member states and manufacturers to share intellectual property on vaccines, have been limited. 

The significant amount of public funding that has gone towards the development of COVID-19 vaccines enables governments to “insist that, as a condition of getting public funding, companies engage in sufficient licensing to enable widespread global production, and they must set affordable prices,” said Kenneth Shadlen, co-author of the Lancet study, and a professor at the London School of Economics and Political Science. 

WHO/UNICEF Call on Countries to Share Excess Doses and For Pharma To Rapidly Scale Up Production – Pharma Warns Against Unrealistic Expectations

The study follows on the heels of last week’s joint statement UNICEF’s Executive Director, Henrietta Fore and Dr Tedros Adhanom Ghebreyesus, WHO Director General, which criticised the “vaccine nationalism” that has dominated the first phases of global vaccine rollout, with 75% of the total doses administered so far taking place in 10 countries. 

“COVAX participating countries are prepared to receive and use vaccines. Health care workers have been trained, cold chain systems primed. What’s missing is the equitable supply of vaccines,” said the statement. 

In order to achieve the goal of beginning vaccinations in all countries in the first 100 days of 2021 – among which 57 countries have not launched vaccine campaigns at all – Tedros and Fore called on governments and pharma leaders to do the following: 

  • Governments to share vaccine doses obtained through bilateral deals so that healthcare workers and high risk individuals in low- and middle-income countries can get vaccinated; 
  • Donor countries to fill the US$27.2 billion funding gap for the Access to COVID-19 Tools (ACT) Accelerator, the global initiative to ensure equitable access to COVID-19 health products and technology, and its vaccine pillar COVAX; and
  • Vaccine manufacturers to allocate their limited vaccine supplies equitably, step up production, and transfer technology and knowledge to other manufacturers to expand the global supply of vaccines.

In response to the WHO/UNICEF statement, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) warned against setting unrealistic goals for vaccine rollout. The IFPMA also said IP rules were enabling innovation that also expands access.  

“Having condensed four or more years of vaccine development into less than a year, through unparalleled partnerships, underpinned by IP, we now have one vaccine that the WHO has approved and others hopefully will be approved shortly,” said Thomas Cueni, Director General of IFPMA. 

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), speaking at the World Health Summit in October.

In response to the calls by UN agencies and civil society for greater technology sharing, IFPMA stated that, “most collaborations – if not all – involved some sort of licensing and transfer of technology, which would not be possible in the absence of a robust global IP system.”

IFPMA noted that there are already 234 manufacturing and production deals arranged for COVID-19 vaccines, representing partnerships that are scaling up to meet the global demands. Examples of deals include those between Johnson & Johnson and Aspen in South Africa; AstraZeneca and the Serum Institute in India; BioNTech and Fosun Pharma in China; and the US-based Novavax and Takeda in Japan. 

“We will continue to do all we can to support [COVAX] delivering the 2 billion doses target for 2021…But understanding the urge for early and equitable vaccine rollout, we warn against setting unrealistic expectations given the inherent risk of vaccine development and the complexity of scaling up manufacturing from scratch,” said Cueni. 

Behind the scenes, there are also some voices in pharma noting that the first port-of-call for WHO and its partners should be at those developed countries that have monpolized markets by purchasing 2-3 times more vaccines than needed to vaccinate everybody – and which could turn the surplus over to COVAX.

IP Waiver Described As Effort to “Erode Intellectual Property Policies”

Meanwhile, the US-based Pharmaceutical Research and Manufacturers of America (PhRMA), called upon the Office of United States Trade Representative (USTR) to oppose a proposal submitted by South Africa and India for a World Trade Organization waiver of IP rules on essential COVID health products – saying that it would undermine the global intellectual property system that fosters pharma innovation. 

The South African and Indian proposal, requesting that the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council temporarily waive certain IP obligations on COVID-19 tests, treatments and vaccines, has become another big bone of contention between developed and developing countries – which see it as a means of gaining faster access to manufacturing capacity.  

The IP waiver proposal by South Africa and India to suspend the protection of IP related to COVID-19 health products is due to be debated again this month in the TRIPS Council, after being shelved late last year, and then being debated again in January – meeting stiff oppositiong from G-20 countries.

In a submission presented on 28 January to the USTR for its “Special 301” report for 2021, which reviews the global state of IP, the US-based PhRMA group also heaped  blame on WHO, the UN Development Programme (UNDP), the UN Conference on Trade and Development (UNCTAD), and Unitaid for supporting the waiver moves behind the scenes and thus – “seeking to undermine and even eliminate intellectual property protections that drive and sustain biopharmaceutical innovation….

“The WHO Director-General even publicly supported an extreme and unnecessary proposal at the WTO TRIPS Council to waive entirely certain international obligations with respect to COVID-19 technologies, even as Member States were still debating this proposal,” said PhRMA’s statement. 

The South African and Indian IP waiver prposal “marks a significant escalation in anti-IP global activism” the PhRMA group added, saying, “Some countries are using the COVID-19 pandemic opportunistically to advance longstanding industrial policies to further erode intellectual property policies.”

But it warned that “The proposal will do nothing to address the production and distribution challenges for making COVID-19 vaccine globally available. If anything the proposal [will] threaten to undermine the ability to respond to another pandemic.”

 

At the most recent WTO meeting in mid-January, opponents to the waiver, which include the US, Australia, Brazil, Canada, the EU, Japan, Norway, Switzerland, and the UK, showed no signs of changing their position on the proposal – which typically would require a consensus agreement by the TRIPS Council, in order to go before the entire membership body of the WTO General Council’s 164 member representatives for approval. 

In a document published on 15 January, proponents of the WTO waiver provided evidence of the disparity in access to COVID-19 health products. The document was supported by Bolivia, India, Kenya, Mongolia, South Africa, and Zimbabwe, among others. 

“Per capita imports of the medical goods essential to mitigate the COVID-19 pandemic have been about 100 times larger in high-income countries in comparison to low-income countries,” stated the document, submitted to the TRIPS Council to respond to questions from several of the waiver’s critics. 

“A solution to this challenge is to diversify and increase production and supply. This requires addressing the legal barrier of IP that prevents diversification and production,” specifically the relevant categories of IP that are implicated are patents, trade secrets, industrial designs, and copyright, said the document. 

The next meeting of the TRIPS Council, on 23 February, will come right on the heels of Monday’s expected election of a new WTO Director General Okonjo Ngozi-Iweala – after the new administration of President Joe Biden removed the US opposition to the candidacy of Iweala which had blocked her election under the tenure of former President Donald Trump.  Iweala, a former high-ranking World Bank official and dual US citizen, was nominated by Nigeria where she both served as a finance minister and economic minister over the past two decades, helping rescue the debt-ridden country from financial ruin.   

As chair of GAVI, and a special WHO envoy on the COVID-19 pandemic, she has spoken up frequently on global health issues, expressing her own deep commitment to ensuring vaccine equity for low- and middle-income countries. In her new WTO role, she will have to steer a delicate course between LMIC’s demands and those of the WTO’s powerful G-20 member states. 

Image Credits: Johnson & Johnson, Pfizer, The Lancet, World Health Summit.

3D rendering of San Francisco based earth imaging company Planet Labs released images of the incident that shows movement of ice before the flash floods in Uttarakhand’s Chamoli district. Image vetted by Climate Data Concierge Project of the Brown Institute for Media and Innovation.

PUNE, INDIA – For Anjal Prakash, a climate scientist based in India, the flash floods in the Himalayan state of Uttarakhand this past week did not come as a surprise. 

“The writing was on the wall,” said Prakash, a research director at the Indian School of Business, Hyderabad, of the 7 February rockslide and avalanche that killed over 32 people with nearly 204 still missing.

The resulting downstream flood washed away a 13.2 MW hydro-electric project on the Rishiganga River and another larger project by the NTPC – India’s largest power utility company that is run by the government. 

The uncertainty about the exact cause of the incident shows the “total lack in the monitoring of these glaciers”, said Prakash.

“We need to have more high-altitude meteorological monitoring to generate data,” said Mohd Farooq Azam, assistant professor of glaciology and hydrology at Indian Institute of Technology (IIT) in Indore. “Currently we have only 12 to 15 glaciers under monitoring.” 

Image released by India’s Indian Space Research Organisation (ISRO) that shows the damage caused downstream due to the flash floods.

The Hindu-Kush Himalayan region is the third largest reservoir of frozen water outside the two poles. Ten of Asia’s largest rivers originate there, providing an estimated 1.3 billion people with water. 

But local and international studies have pointed out that nearly 75% of the glaciers are retreating at an alarming pace due to climate change. 

While scientists are still unpacking the intricate links between glaciers, groundwater and spring systems here, the regional conflicts between India, Pakistan and China also stand in the way of research, data-sharing and mitigation. 

In 2015, Prakash and his colleagues waded through over 7,000 research papers and concluded that climate change was causing drastic changes in the Himalayan region and warned of more extreme events. 

The findings were a part of the special report by the Intergovernmental Panel on Climate Change (IPCC), a UN body formed to assess science related to climate change. 

Infrastructure Projects in a Fragile Ecosystem

As the Indian Himalayas are densely populated, it has been necessary to put in infrastructure for the mountain communities here, including hydropower dams.

“One of the most unfortunate outcomes of the climate policy discourses globally has been a reacceptance of large dams by governments as a viable non-fossil fuel source of energy,” said Manju Menon, senior fellow at the Centre for Policy Research (CPR), a policy think tank.

“This reacceptance is ironic because climate change has also made hydrological flows in the Himalayas erratic and unpredictable, in terms of the impacts on glaciers and monsoon patterns.” 

Menon added that experts have been warning about the impact of engineering on Himalayan rivers for decades; now more than ever, development and environment policies need to be designed so as not to put people at a greater risk than they already are in due to climate change.

“The construction of the dams generates local pollution and black carbon [tiny particles of soot] which settles on the glaciers. But in the long run they reduce carbon emissions and are helping save the environment at the global scale,” said Azam.

But black carbon also is a climate-changer, speeding up the rate of melting of ice, and Azam said it was time to reconsider the siting of such dams to minimize the damage. 

India was ranked as the seventh most vulnerable country in the world for extreme weather events in 2019 by Bonn-based think tank Climate Watch.

The country urgently needs more investment in primary healthcare including at address the health impact of climate change. But India’s health sector has seen little real increase this year, according to the data journalism initiative IndiaSpend. 

Following the flash floods India’s Prime Minister Narendra Modi spoke to the authorities in the state and promised all possible support to the affected in Uttarakhand. The United Nations has offered to contribute to the ongoing rescue and assistance efforts if necessary. A team of scientists from India’s defence research organisation DRDO-SASE were flown in to survey the area.

It will be another few days – or even weeks -before the government scientists present their official assessment of the incident.

Image Credits: Planet Labs.

Dr Peter Ben Embarek, head of the WHO investigative team and food safety expert.

None of the hypotheses about the origins of the SARS-CoV2 virus have been discarded and the World Health Organization (WHO) origins mission might be expanded to include other experts to take forward new areas of research, WHO Director General Dr Tedros Adhanom Ghebreyesus told the body’s bi-weekly media briefing on Friday.

“I wish to confirm that all hypotheses remain open and require further analysis and studies, some of that work may lie outside the remit and scope of this mission,” said Tedros about the mission which returned earlier this week from a month-long investigation in China.  

Before leaving China on Tuesday, the expert team told a media briefing that it had identified four hypotheses about the origin of SARS-CoV2, including that it originated in a laboratory, which they deemed “unlikely.”

The most likely cause was that the virus was transmitted from bats by an intermediary animal source, while bats as the direct source of the virus or it being transmitted by frozen food were the two other theories.

Team leader and WHO food safety expert Dr Peter Ben Embarek told the briefing that he regarded the mission as a success as it “came to a better understanding of the early days of the pandemic in Wuhan and identified areas for further analysis and research.”

Reacting sharply to a question about whether it could have found more evidence had it gone to Wuhan earlier, Ben Embarek said it was “not a mission to go and chase an animal in the market or chase a patient somewhere.”

“In February, it would have been impossible to be in Wuhan because Wuhan was in total lockdown in the middle of fighting the disease, and that took a few months before the city was reopened and the business returned to normal,” said Ben Embarek.

“Many of these studies have involved thousands of people and researchers in China to conduct. And if we had gone much much earlier we wouldn’t have had the same material to look at,” he added.

Over 97,000 Patient Records Assessed

The team found no evidence of the virus in Wuhan before December. Elaborating on this, Professor Marion Koopmans, team member and head of the department of Viroscience at the University of Rotterdam, said that the team had examined mortality statistics to see whether they could identify any unusual death patterns, as well as reports of influenza.

They assessed 97,000 patients’ records and narrowed down 92 cases of COVID-like symptoms in Hubei Hospital – but none of the patients that they could trace tested positive for the virus, although a few could not be traced or had died.

“All the potential cases were tested for COVID-19 and were negative, the one question that is out there is, can you still rule that out, a year after an infection, the serology is negative then,” said Koopmans, who added that there were ongoing discussions with China about the team getting access to blood banks to test samples.

Ben Embarek said that the mission had been “successful in many ways,” and had provided evidence that there was “no widespread and no large cluster of the disease in Wuhan, or elsewhere, around Wuhan, in the months prior to December 2019.”

Professor Marion Koopmans, member of the WHO investigative team and Head of the Department of Viroscience at the University of Rotterdam. 

“We have been able to demonstrate that there was substantial circulation of the virus in Wuhan in December 2019, we’ve been able to link genetic sequences of different patients across the city in December with their physical location in and outside the market across the time, from early December to end of December,” said Ben Embarek.

“We have a much better understanding of what happened in the market, the role of the market, we have also been able to trace back all the suppliers of different wild animal products into the market as a potential clue for further studies,” he added.

The team’s findings from their mission and the studies that were conducted will be written in a summary report, due to be published next week, with the full report following in the coming weeks, said Tedros.

Vaccines Likely to Protect Against Severe Disease – Even With Variants

In response to a question about whether the AstraZeneca vaccine would still be effective against variants in the light of the small South African study that showed it had little effect against the 501.V2 variant, WHO Chief Scientist, Dr Soumya Swaminathan, said the body still had hope that the vaccine could prevent “severe infection and death.”

“The trials that have been done so far in South Africa, as well as in Brazil with different candidates have shown complete protection against severe disease and hospitalisation,” said Swaminathan. 

“Our goal in the first wave of vaccinating people is to protect those at highest risk from severe disease, hospitalisation and death. So vaccines are protecting against getting severely ill, even though they may not protect completely against getting infected or mild disease,” she added.

She also urged people who have been vaccinated to “take precautions, to wear a mask, to wash hands, to maintain the physical distancing, to really reduce the risk” as it is still unclear whether they can pass on the virus to others.

However, Dr Bruce Aylward, WHO Expert Adviser, said confirmatory studies would have to come from countries that had these variants.

Vaccines to be Airlifted to Ebola Outbreak in DRC 

Two of the three people infected with Ebola in the Democratic Republic of Congo died, but the source of the outbreak has not been identified, Dr Michael Ryan, WHO Executive Director of the Health Emergencies Programme, said. 

Extensive contact tracing of the three has already taken place, and “over half of those contacts were vaccinated in the previous Ebola outbreak, most of those are actually health workers who were previously vaccinated,” said Ryan, who added that 16,000 vaccines would be airlifted to the affected area from Kinshasha over the weekend and there were 400 doses of monoclonal antibodies to treat those who might get infected.

Image Credits: CGTN.

(DoD photo by Lisa Ferdinando, Flickr)
  • Weak medicine regulators in Africa mean the continent is vulnerable to falsified COVID vaccines being circulated.
  • Sources at international anti-crime agencies argue that Africa’s strong trade routes with China and India are going to allow criminals to introduce shipments of falsified vaccines into supply chains.
  • The World Health Organisation says the global market for substandard or falsified medicines could be worth up to 15% of the total pharmaceutical market.
  • In November 2020, two people were arrested after a consignment of falsified COVID vaccines were discovered in a warehouse in Germiston, South Africa. 

JOHANNESBURG, – On Friday, 6 March 2020, a day after South Africa recorded its first-confirmed case of COVID-19, and a few weeks after Egypt had on 14 February become the first African country to register an infection, Ugandan police arrested a traditional healer and his daughter in a village 120km east of Kampala.

Police spokesperson, Fred Enanga, told Uganda’s New Vision newspaper: “They visited a number of families … telling them that they had discovered a vaccine for the coronavirus disease … The unknowing subjects purchased the said vaccine at a fee that was negotiated with the seller before it would be administered.”

On 19 November, 2020, a far more sinister incident unfolded in a warehouse in Germiston, according to Mlungisi Wondo, acting manager of the South African Health Products Regulatory Authority’s (Sahpra) regulatory compliance unit.

The police, he says, tracked “suspicious freight” from Johannesburg’s OR Tambo Airport to the building east of the city. After opening a “lot of boxes”, an officer called Sahpra for assistance.

“Our inspectors got there and then they saw prefilled syringes, and they [had labels that] were written in Chinese … The two people who were at the site, the owner of the warehouse and the Chinese owner of the consignment were arrested,” says Wondo.

“There were clear indications that the contents of the boxes were going to be sold as genuine COVID-19 vaccines.”

According to Interpol, the “vaccines” had been advertised for sale on a Chinese social media app, WeChat, and had been imported from Singapore as “cosmetic injections”.

Wondo says the police, in cooperation with Sahpra, are “still trying to trace if there were units released into the country. The risk now is, if people are injected with those [fake] vaccines; we don’t know what is in them because we are still doing the tests at the National Control Laboratory in Bloemfontein.”  

Nigeria’s Food & Drug Administration Also Spots Fake Vaccines in Country

On 15 January, Nigeria’s National Agency for Food and Drug Administration and Control (Nafdac) said it was aware of fake vaccines circulating in the country. The agency’s director-general, Mojisola Adeyeye, told a press conference: “Nafdac is pleading with the public to beware. No COVID vaccines have been approved by Nafdac. Fake vaccines … could kill.” 

And on 31 January, a “Dr H. Losho from Lagos”, who also advertises sex toys, clothes and shoes, posted the following tweet: “If you’re interested in 2 shots of Covid Vaccine at 50k each, contact @ad_de_moles. AstraZeneca. Arrives in 2 weeks. You get a card.”

Africa Is Fertile Ground For Distribution Of Falsified Medicines & Stolen Vaccines

These cases show that Africa is fertile ground for distribution of falsified and stolen vaccines. And with the emergence of new SARS-CoV-2 virus variants, such as the  B.1.351. variant (carrying a mutation called 501Y.V2) that was first identified in South Africa, COVID vaccines will become an even more sought-after commodity — because, at least so far, those variants have proven to be more infectious than the original form of the virus. Some are also able to escape the immunity that current vaccines induce, leading to more fear — and desperation — to be protected from such variants by adjusted, newly developed vaccines specific to those variants.

The statistics also show the continent is extremely vulnerable to vaccine crime: A 2018 report by the World Health Organisation  said between 2013 and 2017, almost half of all substandard and falsified medicines found were in sub-Saharan Africa, where regulations are weak, borders porous and the distribution of fake pharmaceutical products is often not even considered a crime, despite the harm they do.

“We’ve found very toxic substances in falsified medicines. First, you are not cured, and then you have seen cases of people who are dying because of the product they were taking,” says Cyntia Genolet, the associate director of Africa engagement at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The organisation represents the world’s major pharmaceutical firms, including most of those making COVID-19 vaccines.

The WHO report estimates that fake malaria drugs alone cause up to 158 000 deaths every year in sub-Saharan Africa, and that the global market for substandard or falsified medicines could be worth $US 200 billion, or 10-15% of the total pharmaceutical market.

Most African countries are unprepared for the potential onslaught of vaccine theft and falsification

In South Africa, one of the African countries worst-affected by the pandemic, the Health Department says at least 67% of the population of about 60-million must be vaccinated to achieve the herd immunity that would effectively end its epidemic.

South Africa’s vaccine roll-out, that would have started with the AstraZeneca vaccine, was temporarily suspended this week, after new, early data showed that the jab only provides 10% protection against mild to severe COVID-19 caused by the new 501Y.V2 variant.

The Health Department announced that the country will now, instead, launch an implementation study that will compare how well three jabs — Johnson & Johnson, Pfizer and possibly AstraZeneca — protect against severe COVID-19 disease caused by the new variant. Severe COVID leads to hospitalisations and death, and protection against it is therefore an important function of vaccines during pandemics.

And, once the country’s roll-out finally takes off, it will be massive and fraught with challenges.

“This roll-out will be unprecedented in scale, importance and complexity. Will there be crime around that? Probably. But I think we have bigger problems, like how are we going to get the vaccine into the arms of millions of people?” says Salim Abdool Karim, an epidemiologist and co-chair of South Africa’s scientific ministerial advisory committee on COVID-19.

Abdool Karim, who also heads up the HIV research organisation, the Centre for the Aids Programme of Research, Caprisa, adds: “The system that’s going to regulate the vaccines seems pretty strong; they say security around the vaccines will be strong.”

But nowhere close to as strong as in Europe and the United States, where almost every entity involved in distributing the jabs, from airports to transport firms to manufacturers, has formed task teams to keep them safe.

New York National Guard troops support state efforts to administer COVID-19 vaccines. (U.S. Army National Guard photo by Sgt. Sebastian Rothwyn, Flickr)

In high income countries, companies have done background checks on staff; GPS trackers are inside every box of vaccines, which are being stored in secret locations; some vials contain black light verification technology (markings that are only visible using equipment that emits ultraviolet rays) to prevent falsification; some firms are using bogus shipments to throw criminals off-track.

But most African authorities, entangled in negotiations to secure vaccines and preparing for the logistical nightmare of getting them to people across vast territories where transport routes are poor and sometimes non-existent, are nowhere near ready to safeguard the vaccines, according to numerous sources interviewed by Bhekisisa, including law enforcement, crime intelligence, customs and border officials, government representatives and crime analysts.

Africa has almost 1.4-billion inhabitants, according to the latest Worldometers population recording mechanism.

In an analysis in late November last year, the WHO warned that “Africa is far from ready for what will be the continent’s largest ever immunisation drive”.

The analysis found that, based on self-reports by all countries, Africa had an average score of 33% readiness for a COVID-19 vaccine roll-out, far below the WHO’s desired benchmark of 80%.

The organisation said less than half of Africa had identified “priority populations” for vaccination, and had plans in place to reach them; only 44% had “coordination structures” in place.

According to the WHO report, only 24% had “adequate plans for resources and funding”; a mere 17% had data collection and monitoring tools ready; and just 12% had plans to communicate with communities “to build trust and drive demand for immunisation.”

Maurice Ogbonnaya, a crime analyst and former security analyst at the National Institute for Legislative and Democratic Studies at Nigeria’s National Assembly in Abuja, says it’s precisely such inadequacies, “gaps” and disorganisation that could allow organised crime groups (OCGs) to insert falsified vaccines into supply chains, and to steal vaccines.

Why is Africa ripe for a COVID vaccine black market?

Inspired by a brother addicted to illegally trafficked codeine in Nigeria, Ruona Meyer spent more than a year infiltrating gangs dealing in illicit pharmaceuticals in West Africa.

She went undercover as a buyer, her contribution to a Emmy Award-winning documentary in 2018, Sweet Codeine, resulting in several arrests and convictions, including that of a pharmaceutical company executive.

[WATCH] Sweet Codeine

“In Africa, you have all the elements necessary to allow a black market in vaccines to flourish,” says Meyer. “Lack of resources, logistics and technical capacity means it’s going to take incredibly long for the roll-outs to happen. That gives organised crime the time and space needed to strategise, adapt to security measures and to insert their products into supply chains. The poverty and official corruption that’s unfortunately prevalent throughout Africa makes their job much easier.”

In its July 2020 research brief analysing the impact of the COVID-19 pandemic on organised crime infiltration in the legal economy and illegal governance, the United Nations Office on Drugs and Crimes (UNODC) says: “Although no country is completely immune from fraud, countries with a high level of corruption are at a much greater risk of being affected.”

Meyer adds: “It also doesn’t help that healthcare workers in Africa, many who are going to be in charge of vaccine supplies, are very poorly paid … Of course criminals will take advantage of this.”

Organized Crime Groups “Ideally Placed” For Trade in Fake or Stolen Vaccines

Interpol East Africa crime intelligence analyst, John-Patrick Broome, says OCGs are “ideally placed”, having “well-developed networks and methodologies” to smuggle falsified, substandard and stolen vaccines.

“Illicit medications are primarily entering the market in eastern Africa through three key areas. There’s the avoidance of regulations, there’s violence-based criminality and there’s corruption … at a number of different levels,” explains the former British Isles border policing officer.

“The organisations in eastern Africa that have responsibility for regulating the legislation and enforcement activities around this form of criminality have been seen to lack some of the autonomy and powers that they require to deal with the illegal trade.”

Meyer says rising infections and deaths and third and even fourth waves of COVID-19, could cause increasing fear, thus driving demand for vaccines up even further.

“At certain stages supplies will be low. This is the gap that the criminals will fill. We’ve seen it happen already with personal protective equipment (PPE) and chloroquine, when the crime groups got their fakes into global supply chains quite easily.”

Chloroquine & PPE Provide Sorry Precedents

Demand for chloroquine, a medication used to treat rheumatoid arthritis, the autoimmune disease lupus erythematosus, and also malaria, rocketed after a French microbiologist claimed in March 2020 it was “efficient” at combating COVID-19.

Former US President Donald Trump also began touting a form of chloroquine, hydroxychloroquine, as a potential cure, even though there was no evidence to prove that the drug could either treat or prevent COVID-19.

[WATCH] Should doctors prescribe chloroquine to COVID-19 patients?

In the months that followed, Voice of America reports, authorities throughout West and Central Africa seized large quantities of falsified and substandard chloroquine. Many of the tablets were compressed chalk. Police in Cameroon raided and shut down several pharmaceutical manufacturers who were producing fake chloroquine.

There’s currently also immense international demand for the anti-parasitic drug, Ivermectin, which is being promoted by some voices in the medical community as prevention of and treatment for COVID-19, although there remains a dearth of clinical trial evidence. Nevertheless, seizures of illicit Ivermectin are occurring around the world, including in South Africa.

Mafia groups are moving illicit vaccines throughout Europe — and cooperate with criminal enterprises in Africa

Lawyers Marius Schneider and Nora Ho Tu Nam, who advise some of the world’s major pharmaceutical companies on intellectual property issues, warned of the probability of the distribution of fake COVID-19 vaccines on the continent in a report published in the Journal of Intellectual Property Law & Practice in May 2020.

“Why are we going to have an issue with the vaccines? Well, it’s very easy: Because the demand will be high, access will be limited, everybody will want to have his shot, and in that kind of situation this vaccine is liquid gold, as it has been called by some, for these criminal syndicates. They will exploit the situation by either stealing the vaccine, or by counterfeiting it,” argues Schneider, a former chairman of the anti-counterfeiting committee of the European Community Trademark Association.

The advocate, originally from Belgium, founded the IPVocate Africa law firm in Mauritius in 2012 to focus on the “severely neglected” areas of protection, management and enforcement of intellectual property rights in Africa.

Schneider’s practice sometimes coordinates anti-counterfeiting raids with law enforcement agencies and represents pharmaceutical multinationals in legal cases.

“We have seen instances where non-governmental organisations (NGOs) have been engaged in the distribution of these [falsified] vaccines. These NGOs had as a mission to distribute real vaccines to the people. Employees on the ground in African countries were implicated in vaccine trafficking,” he says.

The IQVIA Institute for Human Data Science calculates global spending on pharmaceuticals in 2019 at $1.25-trillion (almost R18.7-trillion). It projects that the global pharmaceutical market will exceed $1.5-trillion (almost R22.4-trillion) by 2023.

Big Money Equals Big Crime

Big money equals big crime, says Ho Tu Nam.

In September 2015, a UK court jailed two former United Nations (UN) consultants for rigging a contract for life-saving drugs between a Danish pharmaceutical firm and government officials in the Democratic Republic of Congo. Guido Bakker and Sijbrandus Scheffer took a bribe of £650 000 (about R13.2-million) to secure a £66-million (about R1.3-billion) tender.

“OCGs have always been interested in pharmaceuticals because of the high profit margins and low risks involved,” says Mark Micallef, North Africa and the Sahel Observatory director of the Global Initiative against Transnational Organised Crime. “They move wherever the greatest profits are to be made at a specific time, therefore it is quite obvious they will get involved in whatever ways they can in the vaccine supply.”

Much of Schneider’s career has focused on organised crime. He participated in the famous “Gomorra” investigation in the 2000s that exposed the sale of counterfeit power tools in Europe, which resulted in the downfall of several figures in the Naples-based Camorra mafia.

“The Camorra had set up production of the tools in China,” Schneider recalls.

Three-Quarters Of Falsified & Substandard Medicines Originate in China  -Africa’s Biggest Trading Partner – and India

The UN estimates in a 2019 report that 75% of falsified and substandard medicines in the world originate from China, Africa’s biggest trade partner, and India, with which the continent also has close relations. The world’s largest vaccine producer, the Serum Institute of India, is already manufacturing COVID vaccines for the drug company AstraZeneca and China has at least three vaccine candidates, two of which are already in distribution.

The UNODC says Italian and Sicilian mafia have for decades trafficked in falsified, substandard and stolen pharmaceutical products, mostly sourced in Asia. 

A senior police investigator in the UK, who asked not to be named because he’s not authorised to give information to the media, told Bhekisisa in early December: “The mafia are moving illicit vaccines in locations throughout Europe.”

He confirmed links had been established between these mafia groups and “criminal gangs in Nigeria, Morocco, Egypt and Ivory Coast”. The Camorra mafia, for example, have also been active in South Africa. In 2014, five Italian nationals linked to it were arrested near Port Elizabeth and charged with trying to sell counterfeit power tools worth millions of rands, IOL reports.

Well-established Routes for Trade in The Opoid, Tramadol, “Waiting to be Fuelled” with Fake Vaccines

Sources at international anti-crime agencies argue that Africa’s strong trade routes with China and India are going to allow criminals to introduce shipments of falsified vaccines into supply chains.

The 1-million AstraZeneca vaccines that arrived in South Africa on 1 February, came via India from the country’s Serum Institute.

On Sunday, the health department also announced that South Africa is in talks with a Chinese company, Sinopharm, with regards to their COVID jab.

Bhekisisa has spoken with a former trafficker of illegal pharmaceuticals in West Africa, who now assists authorities there with investigations.

He says OCGs are “simply waiting for chaos, desperation and no organisation” in vaccine roll-outs before distributing falsified vaccines, or stealing the genuine product.

“Their networks are activated. They will use the same networks, the same corrupt officials that they are using (for other illegal products). They have the printers and the packaging they need.”

Says Meyer: “There have been cases in which employees of pharmaceutical manufacturers sell genuine medicine packaging to criminal groups.”

The ex-trafficker speaks of a “well-established route for [illegal] tramadol [an opioid pain reliever]” between Nigeria and India “that is waiting to be fueled with (fake) vaccine”.

He says links exist between “front companies in Nigeria and their partners in India so they will try to replace tramadol with COVID vaccines because the money to be made is much more. We talk here of one 1000% plus profit on a vaccine”.

Doing the ‘tramadol dance’: What this latest music craze says about Africa’s pill addiction.
(Pic credit: Nyani Quarmyne, Mosaic)

He scoffs: “I’m sure in some cases the police and soldiers are going to be protecting bad [falsified or stolen] vaccines.”

Micallef collects his information about trafficking of falsified medicines in North Africa from a network of 160 field monitors in Algeria, Chad, Libya, Morocco, Niger, Sudan and Tunisia.

“Fake vaccines; I think there’s a big danger of that,” says the analyst. “In the Maghreb itself, so unregulated territories in Libya, definitely. But also in Tunisia and maybe border areas of Egypt, less so in Algeria, perhaps, but especially in the northern Sahel.”

Micallef says OCGs dealing in falsified vaccines exploit gaps in health services and this will be especially true of COVID-19 shots, which is going to make the crime very difficult to control.

“This form of trafficking … is tapping an actual health sector need. And the fear is that in the case of the vaccines a similar scenario might unfold where there are shortages, especially in the (Sahel) border areas, that are preyed upon by criminal enterprise trying to fill that gap.”

In West Africa, vaccine roll-out is set to happen at a time when regional governments, especially Nigeria’s, have been cracking down on tramadol trafficking. Between 1 and 19 June last year, the Nigerian Drug Law Enforcement Agency and the National Agency for Food and Drug Administration and Control seized illegally imported containers of the drug worth more than 300-million naira ($US 786,988), reports Enact, an organisation that works to combat organised crime in Africa.

According to the former trafficker, the tramadol crackdown is providing an additional incentive to OCGs in the region to turn their attention to dealing in falsified COVID-19 vaccines.

A senior security official in Nigeria, who requested anonymity, says criminals in India have been “rebranding and renaming” tramadol to import into the country “as something harmless … The concern is they will do similarly with COVID vaccines”.

Ogbonnaya says many parallels can be drawn between tramadol trafficking in West Africa and the “likely” illicit trade in falsified and stolen coronavirus vaccines.

“It boils down to weak regulation by state regulatory agencies; it boils down to corruption by those who are saddled with the responsibility of ensuring that the regulations are put in place. It also boils down to a complete absence of a continent-wide regulatory framework.”

Many African countries don’t have medicine regulators, making it easier for criminals to operate

The IFPMA supports “regulatory harmonisation” in Africa, in particular via the Africa Medicines Agency (AMA). According to a press release issued by the African Union in February last year, the AMA is “a proposed specialised agency of the African Union intended to facilitate the harmonisation of medical regulation throughout the African Union”.

The treaty establishing the AMA was unanimously adopted by the assembly of the African Union in 2019, but only a minority of nations have so far ratified it.

“There are so many elements that will make Africa more vulnerable during this time of the vaccines being distributed,” says Genolet. “The weak regulatory system is also something that’s been identified by the WHO.”

In the Battle against Fake COVID Vaccines & Medicines – Africa Isn’t Alone

Africa isn’t alone in this.

According to a 2017 WHO global report on medicines surveillance and monitoring systems, only three out of ten countries worldwide have medicine regulators that function “according to acceptable standards.”

On the African continent, there are 54 national regulatory authorities for medical products (NMRAs) on the African continent, but there are “varying degrees of capacity among them” according to a WHO fact file.

However, many African countries don’t have well-functioning regulatory systems, such as South Africa’s SAHPRA (South African Health Products Regulatory Agency) at all. Says one expert: “That’s very important to make sure that medicine that enters a country is safe, and that you can also control what happens after the medicines enter a country.”

Only one NMRA in sub-Saharan Africa — Tanzania’s — has been formally assessed by the WHO. In 2018 it gave the East African country’s regulator a maturity level 3, the second highest on the WHO’s scale.

Andy Gray, senior lecturer in pharmacological discipline at the University of KwaZulu-Natal’s school of health sciences, says previous WHO reports have not identified which African NMRAs “were acceptable and which were not, due to political sensitivity, and the assessment has not been updated. The more mature are certainly the South African, Zimbabwean, Kenyan, Tanzanian, Ghanaian, and Nigerian agencies”.

Gray, who’s also part of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice, adds: “There is some capacity in Uganda, Botswana, Namibia and Zambia. I’m less sure of the Francophone countries, but would expect some capacity in Senegal and Morocco, and perhaps Cameroon; but the ties with France are tighter, and so is reliance on their approved products.”

Gray says it “does not sound far from the mark” to say that only 10% of African medicine regulators have “moderately developed capacity”, with 90% having “little to no capacity”.

Void in Medicine Regulation Leaves the African Continent Exposed

This void in medicine regulation, says the WHO, leaves most of the continent exposed to unsafe medical products and “facilitates the proliferation of substandard, spurious, falsely labelled, falsified and counterfeit medical products.”

Genolet says the frequent absence of regulation means medicine supply chains in Africa are “very porous. This means there’s limited control of the supply chain. When you have a lot of middlemen involved, and borders that don’t always have controls, it makes it easy to move counterfeit medicines into and out of countries.

“South Africa has one of the better [medicine] regulatory systems in Africa, but even it has thousands of kilometres of unregulated borders.”

But Sahpra’s Mlungisi Wondo emphasises: “Vaccines that are substandard or falsified will be blocked by our processes at the points of entry. Our controls are very strong.”

He says inoculations could come into the country through four points of entry, depending on their origins: Durban, Cape Town, Port Elizabeth (all by sea and air) and Johannesburg (air).

“Medicines can’t come into the country [legally] without going through one of those points. At those points we have customs and port health officials that have been trained to assess medicines coming in,” Wondo explains.

This assessment is, however, based on the particular consignment’s appearance, in terms of labeling, relevant registration numbers and attached documentation.

“If the registration certificate of the product is in order, it is released to the pharmaceutical company for eventual release onto the market. Those that do not fulfill registration requirements, the officials refer to Sahpra for further investigation,” says Wondo.

He acknowledges that fake and substandard pharmaceutical products do sometimes “slip through” the checks.

“It will be your smuggling, where people are false declaring, saying it’s clothes, then maybe in the middle of the container they’ll put those boxes of medicines. Those then may go through, because of the false declaration.

“But, with the help of the regulatory compliance inspectors and the South Africa Police Services, we do pick the fakes up inside the country, eventually.”

Vaccine Theft, Rather than Falsified Jabs, could be South Africa’s Challenge

Gray says South Africa’s reputation is one of having a secure medicine supply chain.

But he adds that because Sahpra doesn’t proactively sample the market, relying on good manufacturing practices by pharmaceutical companies and the “vigilance” of their forensic units, it could be missing “problems”.

“If our medicines go across into neighbouring countries, is somebody slipping falsified versions into those countries? We don’t know. Are some of the importers’ medicines that are arriving on our shelves not the ones that we expect to find? We haven’t detected any, but it’s not impossible that they are happening,” says Gray.

Many of South Africa’s vaccines are expected to be made at the Serum Institute of India (SII), which is contracted by the COVAX facility to manufacture vaccines for developing countries.

“The Serum Institute is approved by the WHO to manufacture the vaccines, so we know it will manufacture good quality products,” says Wondo.

The SII is acknowledged around the world as a safe and secure pharmaceutical production facility. But, as Ho Tu Nam points out: “Medicines emerging from every manufacturer in the world have been falsified; no one’s immune.”

Wondo responds: “Each batch of vaccines that comes into South Africa will be tested. Either by us, or by our trusted partner countries. [Falsified] vaccines will not get past our systems. We will keep our people safe.”

Although Gray believes South Africa’s “vulnerable in some ways” to falsified vaccines, and “bypassing of normal actors” in the supply chain represents a “very ripe opportunity to bring a totally falsified product into the market”, like Abdool Karim he’s convinced the country will have “much bigger problems” to deal with, such as the transportation and distribution of shots.

He does, however, think that vaccines are at risk of being stolen in South Africa.

“I think we are far more vulnerable than we even know,” says Gray. “We’ve certainly had theft from the provincial depots and we have a lot of theft happening from hospitals. In fact, we’ve had problems with theft on demand, where people just phone in to a member of staff and a box gets packed up for them.”

Vaccine Distribution Sites May Be The Most Vulnerable Points For  Vaccine Theft 

In South Africa, like in many other countries on the continent, inoculations will happen at public and private hospitals and clinics, pharmacies, mobile centres and places of work. There might also be larger venues where a big number of people can be vaccinated in a relatively short space of time.

Gray believes these vaccine administration sites will be the most vulnerable points along the distribution chain, because they’ll be under much less scrutiny than vaccine shipments.

Meyer says this will be true continent-wide, but he adds:

“I’ve got confidence in the African Union getting verified, real vaccines into Africa. After a few initial issues with fake PPE, it did a great job coordinating PPE supplies.

“Where we’re going to have the problem in Africa is with the distributors; in this case, the ministries of health, the little primary healthcare centres that get it from the ministry of health, and further down the line.

“That’s where we are going to have problems with secure storage; there are not these super-secure storage facilities in most of Africa. That’s where we might have people who steal vaccines, or who might break the content of the vaccine. The same way somebody would take pure kilos of cocaine and they’ll mix it with all sorts of things so they can make more profit.”

In East Africa, Interpol’s Broome says the pandemic has already led to an increase in criminal attacks on medical professionals: “due to the perception that they have access to medications of which there’s a large demand of across the region. Doctors have been robbed at gunpoint in the belief that they have this access. Organised crime groups have sought to exploit corrupt medical professionals also.”

Abdool Karim is sure there will be “some” theft related to the vaccine roll-out in South Africa. But he adds: “I can’t see how people are going to really steal vaccines and sell them in the black market. If they do, it’ll be a very small, niche population of the very wealthy who will want to jump the queue. Because everybody’s going to get the vaccine; the government is giving it to everybody for free.”

To Stop Vaccine Crime – We’re Going To Have To Boost Supply 

But free or not, says Meyer, if vaccines are in short supply and infections and deaths are continuing, demand will “skyrocket” and “the door will be open” to theft and the insertion of falsified and substandard vaccines into the supply chain.

“To stop narcotics crime, you cut the supply. It’s going to be the opposite way with vaccines: to stop vaccine crime we are going to have to boost supply. The more legitimate vaccines on the market, the less space that criminals are going to have, the less demand there will be for their fake or stolen products.”

Gray agrees, referring to the beginning of the pandemic when South Africans were encouraged to get flu vaccinations. The state had, however, bought most of the jabs to give to “high-risk” employees in the public sector.

“The private sector was battling to get hold of stock; many patients were phoning around pharmacies; there were allegations that some of the chains tended to get preferential access and independent pharmacies couldn’t get access; everyone was trying to buy something somewhere.”

It’s not hard to imagine this scenario being repeated at some stage during the vaccine roll-out, he says.

“That is a perfect breeding ground for a criminal to step in and say, ‘I’ve got some stock which I can get you, which fell off the back of a truck.’”

This article was produced by the  Bhekisisa Centre for Health Journalism, as part of a series on Covid-19 and organised crime. This investigation was made possible with a grant from the Global Initiative Against Transnational Organised Crime (GI-TOC). Sign up for Bhekisisa’s newsletter here.

Image Credits: Lisa Ferdinando/Flickr, Bhekisisa, Sgt. Sebastian Rothwyn/Flickr, Nyani Quarmyne/Mosaic.

People wear face masks to prevent the spread of coronavirus as they commute inside a metro station amid the COVID-19 pandemic.

New York City – Echoing a message issued by WHO’s Geneva office today, WHO officials in the Agency’s Americas Regional Office stressed that stronger public health measures are desperately needed, alongside vaccines, to reduce transmission and the risk of even more variants emerging. 

“The vaccine is not a silver bullet. The vaccine will not stop transmission next week,” said  Jarbas Barbosa, Assistant Director of the Pan American Health Organization (PAHO), in a briefing in Washington, DC.

Dr Carissa F Etienne, PAHO Director

“Vaccines are not going to solve our problems immediately,” said PAHO regional director Carissa Etienne. She pleaded with policymakers and the public to continue observing social distancing, masking and hygiene measures to reduce virus transmission..

“We have to do everything that we can to reduce the circulation of the virus. And to do that we have to use the proven public health measures,” she said, adding, “Please do not let your guard down as we await vaccines, and even when we get the vaccines. We will simultaneously reinforce all public health measures [in doing this].” The WHO appeal coincided with an announcement by the United States Centers for Disease Control of new recommendations for “tight fit” or “double masks” to improve their virus filtration. 

In Geneva, WHO’s Kate O”Brien issued a similar message – during an announcement of a WHO expert recommendation to approve use of the AstraZeneca COVID vaccine. 

“The issue of whether or not a person who has been vaccinated can take their foot off the pedal and stop using a mask, stop all the interventions we’ve been communication for the whole pandemic – those interventions need to continue for individuals who have been vaccinated and for communities of people as the vaccine is rolling out,” she said. 

Reaching Migrants and Other Marginalized Groups With Vaccines Also Critical  
Dr Ciro Ugarte, Director of Health Emergencies, PAHO

The WHO has set the initial goal of providing vaccines for at least 20% of the population for countries that are part of the COVAX agreement. In the PAHO region, 37 countries are participating in COVAX.  But that coverage will fall far short of what is ultimately needed to really make a dent in transmission, officials said. 

Latin America and the Caribbean will need to immunize approximately 500 million people to be able to control the pandemic, said Etienne, PAHO Regional Director. The PAHO region itself has more than 934 million people. 

Dr Ciro Ugarte, Director of Health Emergencies at PAHO, also pointed to issues of inequity that have plagued the COVID-19 pandemic and the subsequent vaccine rollout, especially among migrant groups in the Americas region. 

Migrants need to become “regularized” in regards to their legal status in countries, which would allow them to access health services and the COVID vaccine, Ugarte said. 

Fortunately, many of the migrants working in the health sector are likely to be included in the first phase of the vaccine. However, others work in informal sectors, preventing them from receiving the vaccine or even being incorporated for future vaccine rollout as many of them remain (and would like to remain) unidentified. 

These issues of vaccine exclusivity that may prevent migrants from receiving the vaccines could even act as a barrier to controlling the pandemic in many of these countries. 

Getting Vaccines Approved Through National Regulatory Mechanisms & Stepping Up Variant Surveillance Also Critical
WHO PAHO
Dr Jarbas Barbosa, Assistant Director, PAHO

 PAHO officials emphasised the need for national health authorities to actively monitor the pandemic trends in their countries, including the emergence and spread of variants. The three variants of greatest concern, which were first identified in the United Kingdom, South Africa and Brazil, have already been detected in twenty countries in the Americas. 

The WHO has already called attention to the potential reduction in vaccine efficacy against variants of the SARS-CoV-2 virus, particularly against the South African strain. Real-time data collection as vaccine campaigns get underway will allow researchers to understand the real effect of these new variants on vaccine efficacy. 

Countries in the Americas are already uploading and publishing locally-identified genome variants in GISAID, a global platform for genomic data of influenza viruses and SARS-CoV-2. This information will contribute towards improved genomic surveillance. 

PAHO is providing countries with equipment for genome sequencing and technical guidance in the identification of variants.  But officials also called upon national authorities to also step in with more funding for their own laboratory networks. 

Ensuring that new vaccines receive rapid regulatory approval at national level is another key PAHO concern. PAHO has already asked countries to send their plans for regulatory review to the Agency, in order to identify needs and gaps. Thirty-one countries in the Americas region, which includes North America and Latin America and the Caribbean, have already shared their information, while twenty countries have yet to send in their plans for review. 

“It is not sufficient to have a vaccine, all the countries need to have all the regulatory mechanisms [in place] as well as licenses for importation,” said Barbosa. 

Image Credits: Flickr: IMF Photo/Joaquin Sarmiento, PAHO.

Ngozi Okonjo-Iweala – poised for election next week as Director General of WTO.

In her first major public statement since the United States signaled that it would approve her candidacy for Director-General of the World Trade Organization (WTO), Ngozi Okonjo-Iweala highlighted the need for rich countries to step up their financial contributions to ensure equitable access to COVID-19 tools.

Okonjo-Iweala was the keynote speaker on Tuesday at the fourth meeting of the Access to COVID-19 Tools (ACT) Accelerator Facilitation Council, where a new burden sharing agreement to recruit more funds from donor countries to fill a $27 billion funding gap was announced. The Council needs the money to rollout key components of the ACT’s flagship project, COVAX, the global vaccine distribution facility, as well as parallel initiatives to ensure global access to COVID-19 tests and treatments.  

Okonjo-Iweala’s appointment as the first woman and first African DG of the WTO is likely to be confirmed next week; WTO members are now set to reconvene Monday – following the shift in the US position, which had been the sole outstanding obstacle to her election last December. 

As she takes over the helm of the WTO, Okonjo-Iweala will have to negotiate a thorny course in a heated COVID-related debate among trade delegates. Low- and middle-income countries, led by South Africa and India, are seeking WTO approval for an “IP waiver” on all COVID-related health products, for the duration of the pandemic – while rich countries that have opposed the move. 

In her comments before the council, Okonjo-Iweala, steered a middle course during the meeting, calling for greater equity in vaccine distribution and more donor funding to support the global COVAX facility and other ACT Accelerator initiatives co-sponsored by WHO and a range of other UN agencies and public-private partnerships. Okonjo-Iweala is currently the WHO Special Envoy for the ACT Accelerator, which was established in April 2020.

Echoing the message conveyed by Dr Tedros Adhanom Ghebreyesus, WHO Director General, in his opening remarks, Okonjo-Iweala emphasised the current inequity in the global vaccine rollout, with people in over 60% of high-income countries being vaccinated, while only a handful of low-income countries have received doses so far. 

The COVID-19 vaccination doses administered globally per 100 people, as of 8 February 2021.

“If we want to stop this pandemic from spreading and mutating, we need to change the way this map looks as fast as we can,” Okonjo-Iweala said, referring to the map of the administered COVID-19 vaccines per 100 people in the population.

We Cannot Delay The Rollout Of Tools

“We cannot delay the rollout of tools around the world. Equitable access to COVID-19 tools is not just a moral imperative, as Dr. Tedros said, it is a strategic and economic one as well. Global solidarity is the fastest, most effective way to defeat the pandemic,” declared Okonjo-Iweala. 

She praised the the ambitious ACT Accelerator initiative as the “fastest, most coordinated and successful global effort in history to develop these tools to fight the disease.”

However, the initiative is plagued by “persistent underinvestment in global solutions and increasing bilateral action,” which undermines the ability of the COVAX facility to procure vaccines for participating countries, including the world’s poorest countries, at an affordable price, she noted. 

“Governments everywhere are under immense pressure to secure doses for all of their citizens. Many cannot afford the bilateral deals, others are still seeking them, and some have secured more doses than their populations require. Solving these problems requires all of us to come together to find solutions,” Okonjo-Iweala said.

“Given the contraction in available official development assistance, many more countries will have to bite the bullet and find sustainable ways to finance and co-finance COVID-19 tools, including through multilateral development banks,” she added.

Countries participating in COVAX are prepared to begin receiving doses and COVAX is prepared to start distributing the vaccines, having already released an interim distribution forecast for the first and second quarter of 2021, however, adequate supplies of the vaccines may not be available to meet the needs of countries. 

“The ACT Accelerator’s COVAX vaccines facility is poised for the fast track distribution of two plus billion doses of internationally recognised safe, effective, and quality assured vaccines across 109 participating countries and economies. And countries are ready…However, there are challenges,” said Okonjo-Iweala. 

“Countries, manufacturers, regulators, civil society, and actors in the multilateral system all have a role to play to ensure that vaccines reach people in all countries, prevent infection and end this pandemic everywhere….This is why we’re here today,” Okonjo-Iweala added. 

Pharmaceutical Companies Dedicated to Ensuring Equitable Access to Vaccines

Meanwhile, the CEO of AstraZeneca, Pascal Soriot, also appearing at the meeting, said he believed the company’s vaccine can remain a critical anchor of the global COVAX effort to roll out vaccines in low- and middle-income countries – despite the poor initial showing the AstraZeneca vaccine has made in stopping mild and moderate disease from a SARS-CoV2 virus variant that first emerged in South Africa.

“Our commitment as a company to supply COVAX, together with our collaboration with the Serum Institute of India, who are developing the vaccine together with us, means that over 300 million doses of the vaccine could be made available to 145 countries in the first half of this year, subject to regulatory approval,” said Soriot. The AstraZeneca vaccine is one of the backbones of the global initiative, with the largest commitment of vaccine volumes to COVAX so far. 

Pascal Soriot, CEO of AstraZeneca, at the ACT Accelerator Facilitation Council meeting on Tuesday.

“Our supply to COVAX means that on average 3% of people in these countries will receive the vaccine. And I’m really proud to say that 61% of our projected supply for COVAX during this period of time is due to go to low and middle income countries,” said Soriot.

On Sunday, however, the vaccine’s image in Africa suffered a major blow as South Africa announced that it was putting the rollout of the Oxford/AstraZeneca vaccine on hold due to data showing low efficacy against the B.1.351 variant that has been spreading in the country.

Soriot stressed, however, that the vaccine still should be able to protect against severe disease. A recent study in Great Britain has also been encouraging, suggesting that the AstraZeneca vaccine may not only prevent disease in those who are immunised, but also reduce virus transmission to others by as much as two-thirds. 

“Right now it is essential that vaccines continue to be administered to as many people as possible,” as the benefits of vaccines far outweigh the risks of their potential lower efficacy against the new variants, said Soriot. 

“We will never fully stop COVID-19 until everyone everywhere has access to an effective vaccine. The need to bring COVID-19 vaccines to the world equitably has become even more pressing in recent weeks as we see more infectious strains of the virus emerge in multiple countries and spread rapidly across the world,” said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, who also appeared at the meeting.  

While pausing the rollout of AstraZeneca, South Africa is accelerating its plan to vaccinate people with the J&J vaccine, which showed reasonable efficacy against the B.1.351 variant in recently reported Phase 3 trial results.

“Since day one of our program we have been committed to bringing an affordable COVID-19 vaccine on not-for-profit basis for emergency pandemic use,” said Stoffels. 

Paul Stoffels, Chief Scientific Officer at Johnson & Johnson.

As part of the Johnson and Johnson commitment, the company has pledged to provide up to 500 million doses of its single-dose vaccine to low income countries through COVAX in an agreement signed with GAVI, The Vaccine Alliance, in December of last year. 

“Beating COVID-19 will require constant surveillance, continued innovation, including potential boosters development, and all the new vaccine strategies and close partnerships between government and vaccine makers. Only through innovative collaboration fueling new ideas, well planned implementation of equitable approaches, as well as constant vigilance and a sense of urgency will the world beat COVID-19,” said Stoffels. 

Council Discusses New “Burden Sharing” Arrangement To Prod Donors To Fund Budget Gap 

Meanwhile, the Council discussed the refined financing framework, which included a burden sharing mechanism, and the updated priorities and strategies for the ACT Accelerator for 2021. 

In light of the successes in the development of vaccines, diagnostics, and therapeutics, as well as the evolving knowledge about the necessary measures to combat COVID-19 globally – informed by the spread of virus variants and the increasing fragmentation of international collaboration – the ACT Accelerator launched its ‘refreshed’ strategy on Tuesday.

The four new strategic priorities for the ACT Accelerator in 2021.

For 2021, the four core priorities of the ACT Accelerator are: rapidly scaling up the doses available for vaccinations, particularly for the COVAX facility; bolstering R&D to address the virus variants; stimulating the uptake of tests and therapeutics in low- and middle-income countries; and ensuring a robust supply pipeline is established to deliver essential tools to low- and middle-income countries. 

In addition, new and existing financing sources were evaluated through the Council’s finance working group to develop a robust financing framework to ensure the promise of ACT Accelerator is realised. 

The funding commitments to the ACT Accelerator currently total US$6 billion, with the United Kingdom, Canada, Germany, and the Diagnostics Consortium for COVID-19 contributing the most. An additional US$4 billion is projected in funding.

The ACT Accelerator is facing a US$27.2 billion funding gap, of which US$19.2 billion is needed from high-income and upper middle-income countries to fully finance the initiative, according to John-Arne Røttingen, Ambassador for Global Health for the Norwegian Ministry of Foreign Affairs and a member of the Council’s finance working group.

“We are gravely concerned that the current ACT Accelerator’s funding gaps will impede global equitable access to these products and ultimately delay the end to the crisis everywhere,” said the Council co-chairs, Zweli Mkhize, South Africa’s Minister of Health, and Dag-Inge Ulstein, Norway’s Minister of International Development, in a statement released in December. 

The new financing goals and needs to close the funding gap for the ACT Accelerator, presented at the Council meeting on Tuesday.

To recruit funding to fill this gap, a burden sharing framework was developed to determine contribution based on GDP and the level of openness of the economy, with a greater proportion of income paid by richer countries. Countries are then categorised into different ranges of contributions.

A preliminary illustration of what this grouping of countries may look like was introduced at the meeting. While the burden sharing mechanism is not yet fully developed, officials hope it could lead to a rise in contributions.

The grouping of countries under the new burden sharing mechanism proposed by the financial working group of the ACT Acceleration Facilitation Council.

“This is a joint responsibility. We really need to have a framework for splitting the bill responsibly…not based on an old model of donations from a few, but on a new model of collective contribution from a much larger group of countries,” said Røttingen. “This is solidarity in action.”

“We really hope that now countries, hopefully, will increase the contributions in the weeks and months to come [and] they will actually link this to a framework of fair financial contributions from everyone,” he added. 

Member states were largely supportive of the financing framework launched on Tuesday.

“We are currently considering additional contributions and urge all partners, especially other G20 countries to step up their support for ACT A,” said Germany’s delegate. “In addition, we would welcome stronger involvement of the private sector…We have to work together to close this acute funding need.”

“From the UK, we welcome the new and prioritised strategy and the budget for 2021 and we must continue to optimise international and domestic resources,” said the UK’s representative. “For the UK’s G7 presidency, we are going to work with fellow G7 nations to drive an ambitious health agenda that exactly reflects these principles…on equitable and affordable access.” 

Similarly, Italy, which will hold the G20 presidency in 2021, “stands ready to mobilise the political support needed for the ACT Accelerator and the COVAX facility to deliver concretely on the commitments undertaken within the G20 almost a year ago,” said Italy’s delegate. 

Bruce Aylward, Senior Advisor to the WHO Director General and lead for the ACT Accelerator, thanked member states for their “strong endorsement for the vision…in the strategic plan and budget for 2021. It sounds like that plan is right, the priorities are right and the budget is necessary,” he said.

Bruce Aylward, Senior Advisor to the WHO Director General and lead for the ACT Accelerator.

Aylward also expressed gratitude to Japan for its announcement of additional contributions, and to the “UK and Italy, who committed their presidencies of the G7 and the G20 respectively to take forward the ACT A agenda.”

Success of ACT Accelerator and COVAX Threatened

Meanwhile, Dr Tedros warned of the significant challenges and threats to both the ACT Accelerator and the COVAX facility. 

“We have created a dose-sharing mechanism, set up rapid processes for the emergency use listing, set up indemnification and no-fault compensation mechanisms and completed readiness assessments in almost all AMC countries,” said Dr Tedros at the Council meeting.

However, while progress was made, the success of COVAX and the ACT Accelerator is threatened by the $27 billion financing gap, countries signing bilateral vaccine deals that compete with COVAX contracts, and current disruptions in vaccine manufacturing processes. 

Tedros called on countries to donate vaccines and share doses instead of vaccinating lower-risk groups and called for pharmaceutical companies to establish partnerships to develop manufacturing capacities and deal with production obstructions. 

“We need an urgent scale-up in manufacturing to increase the volume of vaccines. That means innovative partnerships including tech transfer, licensing and other mechanisms to address production bottlenecks,” said Dr Tedros.

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

Brazil’s delegate followed up on Tedros’ point and called for the Council to “move beyond principles and…talk about how to make vaccines available to everyone everywhere,” by expanding local vaccine production using licensing and coalition building.

Norway also expressed its support for using technology transfers and voluntary licensing to increase the global production capacity and stressed the importance of the equitable pricing of products.

“We call on pharma companies to implement pricing strategies that take countries’ different levels of ability to pay into account. Companies should agree cost plus prices with the COVAX facility for the countries eligible for the advanced market commitment,” said Norway’s delegate.

Additionally, taking a step to address the funding gap, Tedros “call[ed] on OECD and DAC countries to commit a proportion of stimulus financing to close the funding gap, and to take measures to unlock capital in multilateral development banks.” 

Shift in US Role On Council

The United States announced at the Council meeting that it would shift its role from observer to participant in the Council, making a commitment to multilateralism that follows its decision to rejoin the WHO and take part in COVAX. This move was widely acknowledged and well-received by member states.

“As President Biden expressed on his first day in office, the United States will partner with the WHO and the entire UN system to respond to COVID-19, improve global health and health security, and build a better future for all people,” said the US’ delegate.

“I would like to begin by welcoming the United States of America to the ACT Accelerator,” said Dr Tedros in his opening remarks. “We’re glad to have your support and involvement, and we look forward to your partnership in ensuring that all countries enjoy equitable access to vaccines, diagnostics and therapeutics against COVID-19.”

Image Credits: World Bank Photo Collection, WHO, Our World in Data.

The international team working to understand the origins of the COVID-19 virus at a press conference in Wuhan, China on Tuesday.

The most likely way that the SARS-CoV2 virus spread in Wuhan was from an animal intermediary that transmitted the virus from bats to humans, while the least likely was that it resulted from a laboratory “incident”, according to the World Health Organization (WHO) team on the origin of the virus, which completed a month-long investigation in China on Tuesday. 

Despite reviewing thousands of tests on wild and farm animals in the country, it has not been possible to identify any animals infected with SARS-CoV2 and team leader Dr Peter Ben Embarek, told a press conference in China on Tuesday that more research needed to be done on the cold chain supply of frozen wild animals.

China has been pushing the theory that the virus was imported into the country via frozen foods for some time now. Dr Liang Wannian, head of the Chinese expert panel on COVID-19, told the press conference on Tuesday that “studies have shown that the virus can survive for a long time not only at low temperatures, but also at refrigerator temperature, indicating that it can be carried long distances on culturing products.” 

Liang Wannian, head of the expert COVID-19 panel at China’s National Health Commission, at the WHO press conference on Tuesday.

Differences in WHO & China Narratives About Possibility That Virus Emerged Abroad 

There were, however, subtle but significant differences in the narrative related by the official Chinese representatives at the media briefing and the members of the WHO team. 

While China’s Wannian spoke about the frozen food chain, suggesting products carrying the virus that triggered the Wuhan clusters may have been imported, the WHO’s Embarek made it clear that more research needed to be done on whether the virus could have reached Wuhan from a domestic food source – or an imported one. 

The Wuhan market, one of the places where the virus first appeared, sold “mostly” seafood products, including frozen foods, “but also vendors selling products from domesticated wildlife, farmed wild animals and their products,” said Embarek.

“So the joint team in their studies have identified the vendors who were trading these type of products, identified the suppliers of these vendors, identified the farms, from where these products were coming from – and they were coming from different parts of the country, and some of the products were also imported products, of course,” said Embarek, who is also WHO’s head of food safety and zoonoses.

“So, there is the potential to continue to follow this lead, and further – look at the supply chain, and animals that were supplied to the market in frozen and other processed and semi-processed forms, or raw form.”

Peter Daszak, one of the scientists on the mission echoed Embarek’s remarks in a Tweet directly from the press conference: “KEY COMMENT: Recommendations include sampling potential intermediate hosts & bats both inside & outside China. Possible role of cold chain – incl. “Frozen wild animal that could have been infected by [progenitor] of SARS-CoV-2.”    

Wuhan Laboratory & Direct Bat-Human Contact Ruled Out As Infection Routes

Bats are a reservoir for cornaviruses that circulate in nature

What the Chinese and international scientists did seem to agree upon was that there was little possibility that the virus had somehow escaped from the Wuhan Virology laboratory – as some voices in the administration of former US President Donald Trump had tried to suggest. They also agreed that there was little evidence that people were directly infected from bats harboring the coronavirus themselves.  

Studies have shown that coronaviruses most closely related to SARS-CoV2 are found in bats, which suggests that these animals may be the original reservoir of the virus that causes COVID-19.

Embarek said that the team had investigated whether there had been direct zoonotic spillover from bats to humans but the genome sequencing of the virus in bats was too different from the SARS-CoV2 that emerged in humans to indicate direct transmission, and there was also no obvious connection between Wuhan residents and bats.

“All the work that has been done on the virus and trying to identify its origin continue to point towards a natural reservoir of this virus and similar viruses in bat population,” said Embarek.

“But infection directly from a bat to the city of Wuhan is not very likely. And therefore, we have tried to find what other animal species were introduced and were moving in and out of the city that could have potentially introduced the virus.”

Pangolins, which are widely sold in Chinese markets as wild foods, are another key animal source that was mentioned by both Chinese and international teams at the press briefings as a possible original reservoir – or an “intermediate host”.  

At the press briefing, China’s Wannian also suggested cats and minks could have become the “intermediate source” for the initial coronavirus infections that reached humans. 

China has pointed a finger at minks in the past, after SARS-CoV2 infections in mink farms in Europe had become a widespread issue, leading to the culling of tens of thousands of mink over the past year. 

However, it is widely assumed that the minks were infected by humans after Europe became the epicenter for COVID-19 last spring. WHO’s officials said in December that there is so far no evidence that coronaviruses similar to SARS-CoV2 circulated in the wild in Europe – before the pandemic.  

No Evidence of Virus Circulation in Wuhan Before December 2019 

Marion Koopmans, virologist and WHO advisor on foodborne diseases and emerging disease outbreaks, at the WHO press conference on Tuesday.

The Chinese and WHO/International expert team, also did not find any concrete evidence of the virus circulating in Wuhan before December 2019, said Embarek. 

However, when the first Wuhan virus clusters were identified in December, these were not confined only to the city’s seafood market – that was initially perceived as the original source of the outbreak  – but popped up elsewhere around the same time.

“We agree that we have found evidence of wider circulation of the virus in December 2019,” said Embarek. “It was not just only a cluster outbreak in the Huanan market, but the virus was also circulating outside of the markets in a very classical picture of the start of an emerging outbreak.”

While the virus, which circulates mainly in wild bats and some pangolins, is believed to have jumped at some point to an “intermediate animal host”, which in turn infected the first humans, the team has not gotten close to how, where or when that animal-human leap really occurred.

During the visit, the team reviewed sampling from extensive PCR tests of livestock and poultry from 31 Chinese provinces and 50,000 samples of the wild animals covering 300 different species, but not a single one was found to be infected with SARS-CoV2.

This was why the team flagged that more research needed to be done on the cold chain supply to see whether infected frozen and semi-procssed animal products, including wild animal products, could have been the virus conduit, said Embarek.

Dutch virologist Professor Marion Koopmans also told the press conference that further animal studies needed to see what other animals could have played a role as intermediate hosts.  Rabbits had been confirmed as susceptible to SARS-CoVD, while ferrets, badgers and bamboo rats are also suspected of being susceptible.

“The way that is interpreted is to really say, well, if they were there then, then maybe there could have been similar animals earlier. It is an entry point for a traceback investigation, “ said Koopmans.

Reports of Virus Circulating in Italy earlier than December Also Need to be Investigated

However, Koopmans told the press conference that reports of the virus circulating in Italy earlier than December also need to be investigated.

She was referring to several recent Italian publications suggesting that SARS-CoV2 antibodies were found in blood samples of Italians who had undergone screening for other reasons during the autumn of 2019. Another study found traces in sewage in Milan and Turin.  Those findings suggest that the virus was already circulating under the radar in the country earlier than had been believed. 

“A couple of publications suggest that for instance, in Italy the virus had been already in circulation in December, maybe late November 2019, but it is difficult to know because the methods for that are not were not confirmatory,” said Koopmands. “So, in the next step, what we say is, we should really go and search for evidence for earlier circulation, wherever that is indicated.”

The international, multidisciplinary team was established by a World Health Assembly mandate to design and conduct a series of studies to trace the origins of SARS-CoV2 and the route of its introduction into the human population. The team is comprised of 17 Chinese experts and 17 international experts. Their long-awaited visit to China was delayed for months as Chinese officials, who have been keen to cast the blame for the virus elsewhere, stonewalled over the terms and conditions. 

Image Credits: WHO, CGTN, Shutterstock .

Ebola vaccination campaign in Mbandaka, Équateur Province (DRC) during an outbreak over the summer.

The Democratic Republic of the Congo (DRC) recorded its first case of Ebola on Sunday in Butembo – a city that was one of the epicenters of the last Ebola outbreak – since its last outbreak ended in June 2020. 

A woman with Ebola-like symptoms was detected in Butembo, a city in North Kivu Province, after seeking treatment at a health center on 1 February. She died in the hospital two days later, reported the Ministry of Health of the DRC. 

The patient was married to a man who had contracted Ebola during the previous outbreak. 

“The provincial response team is already hard at work. It will be supported by the national response team which will visit Butembo shortly,” the Ministry of Health said in a statement.

This new case comes nearly eight months after the country’s 10th Ebola outbreak, which ended after two years with a total of 3481 cases, 2299 deaths and 1162 survivors reported. Local and national authorities, along with the WHO, are investigating the case, contact tracing, and disinfecting sites visited by the patient.

During the previous outbreak, WHO trained laboratory technicians, contact tracers, and vaccination teams, leaving behind a strong local and provincial health system with the capacity to mobilize and lead the current response.

“The expertise and capacity of local health teams has been critical in detecting this new Ebola case and paving the way for a timely response,” said Matshidiso Moeti, WHO Regional Director for Africa, in a press release. “WHO is providing support to local and national health authorities to quickly trace, identify and treat the contacts to curtail the further spread of the virus.”

Samples from the patient have been sent to the National Institute of Biomedical Research to sequence the genome, identify the strain of the Ebola virus and establish its link to the previous outbreak. 

“It is not unusual for sporadic cases to occur following a major outbreak,” said WHO in a statement, however it is unclear if this is evidence of a flare up or a new outbreak.

“While there is hope that this early identification of an infection may help with quickly containing this outbreak, back-to-back Ebola outbreaks and Covid-19 has stretched Congo’s health systems to the limit and this could put far greater strain on an already exasperated system,” Jason Kindrachuk, assistant professor at the department of medical microbiology and infectious diseases at Canada’s University of Manitoba, told the Guardian. 

More than 70 contacts have been traced by local health authorities, the Ministry of Health, and WHO epidemiologists on the ground in an effort to detect, contain and treat any other cases.

“So far, no other cases have been identified, but it is possible there will be further cases because the woman had contact with many people after she became symptomatic,” said Dr Tedros Adhanom Ghebreyesus, at a press briefing on Monday. 

Ebola vaccines are being sent to the area and a vaccination program will begin shortly, supported by a rapid response team sent by WHO. 

Image Credits: WHO/Junior D. Kannah.

AstraZeneca’s multi-stage manufacturing and quality testing process for its COVID-19 vaccine, which was developed with Oxford researchers.

The World Health Organization (WHO)’s expert group on immunisations remains confident in the Oxford/AstraZeneca vaccine’s efficacy against severe SARS-CoV2 disease – despite the enormous worldwide concerns triggered by a small South African study that showed it had little effect in stemming mild disease from the B.1.351 variant first identified in that country.

“It is very clear that the vaccine has efficacy against severe disease, hospitalizations and deaths,” Dr Katherine O’Brien, WHO director of Immunization, told the body’s bi-weekly media briefing on Monday after WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) meeting to decide on whether to grant the vaccine an emergency use license earlier in the day. 

“There is also evidence that the likelihood of meaningful impact against severe disease is a very plausible scenario against the B.1.351 [South African identified] variant,” O’Brien added, explaining that SAGE had met earlier in the day with investigators from Oxford/ AstraZeneca trials in the UK, Brazil and South Africa.

Dr Katherine O’Brien, WHO Director of the Department of Immunization, Vaccines and Biologicals.

Stressing that the situation was dynamic, O’Brien said that evidence unfolding from the trial of people with mild disease, might seem to contradict expert opinions that the vaccine could still prevent  severe illness – but that was because “we’re painting the picture in parts and pieces and bits”.  So  far the ongoing trials have not yielded clear evidence of the AstraZeneca’s efficacy on the South African variant. 

Last Friday, WHO officials said that they would be set to make a decision on approving the AstraZeneca vaccine for widespread rollout by the Global COVAX facility sometime this week.

WHO Director General Dr Tedros Adhanom Ghebreyesus described as “concerning” the news that the AstraZeneca vaccine was “minimally effective at preventing mild to moderate disease caused by a variant first identified in South Africa”.

COVAX Suppliers Need To Be Prepared to Adjust Products To Viral Evolution

Meanwhile, Dr Seth Berkley, CEO of the vaccine alliance, GAVI, stressed that pharma manufacturers supplying vaccines to the global COVAX facility “must be prepared to adjust to COVID-19’s viral evolution, including potentially providing future booster shots and or adaptive vaccines, if found to be scientifically necessary”.

Seth Berkley, CEO of Gavi, the Vaccine Alliance

“COVAX has signed advanced purchase agreements with AstraZeneca and the Serum Institute of India, and we’ve published plans to distribute near nearly 350 million doses in the first half of the year, hopefully starting later this month, should the emergency use listing be forthcoming,” said Berkley, who added that while COVAX was currently dependent on AstraZeneca and Pfizer vaccines, other vaccines would be added to its portfolio later in the year.

Richard Hatchett, CEO of  the Coalition for Epidemic Preparedness Innovations (CEPI) stressed that a diversity of vaccine candidates “provides us with a large number of tools which we need to explore to see which works best against the variants.”

“We can also look potentially at combinations of the vaccines and of course we must accelerate the development of new strain-specific vaccines. A large number of companies have already begun to undertake that work,” said Hatchett.

Image Credits: AstraZeneca, WHO.

Civil society organizations, pharmaceutical industries, and other stakeholders support the ratification of the AMA Treaty.

On the two-year anniversary of the establishment of the African Medicines Agency (AMA) Treaty, over 40 patient and civil society organizations, health and pharmaceutical industries, and product development partnerships called upon African Union member states to ratify the Treaty. 

Rapidly ratifying the Treaty, which was created to provide a unified approach to the approval of new medicines and vaccines, is a “matter of priority” and the failure to do so undermines patients’ access to effective therapies and vaccines, according to the numerous stakeholders representing patients, researchers and industry leaders. 

The Treaty was adopted at the 32nd African Union Assembly to enhance regulatory oversight across the continent’s 54 countries. It has been signed by 19 countries but only ratified by eight out of the required 15. 

“The African Medicines Agency is important for universal health coverage [UHC] in Africa. The 148th World Health Organization’s Executive Board has resolved to ask the 74th World Health Assembly to adopt the WHO Flagship Global Patient Safety Action Plan 2021-2030,” Kawaldip Sehmi, CEO of the International Alliance of Patients Organisations (IAPO), told Health Policy Watch. 

“A cornerstone of this plan is that each Member State must have a competent institutional, legislative, policy, practice and standards framework in place for the regulation of safe and quality innovative medicines, health devices and other health products. The African Union, like the European Union and its European Medicines Agency, can ensure that all 54 African countries can place this cornerstone of their UHC together at the same time,” he added.

The AMA has a critical role to play, particularly in the midst of the COVID-19 pandemic, when a competent and efficient regulatory authority – similar to the European Medicines Agency or the US Food and Drug Administration – is needed to review, approve and monitor vaccines, therapeutics, diagnostics and health technologies. 

“If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic” and to ensure their rapid and streamlined introduction to markets, said John Nkengasong, Director of the Africa Centres for Disease Control and Prevention, at press briefing in October.

As COVAX, the global initiative to procure and equitably distribute COVID-19 vaccines, prepares to start shipping 90 million doses to Africa in February, the continent is almost two months behind vaccine rollouts that began in Europe and the US in December. 

“That is precisely what the AMA’s mission will be: to help African countries fight disease outbreaks by ensuring that only high-quality drugs, vaccines, and other health-related supplies reach the market and health systems from Cape to Cairo,” said Sehmi in a press release. 

Similarly, disruptions in the approval or rollout of vaccines could be investigated and solved by a regional regulatory agency. South Africa’s decision on Sunday to halt its use of the Oxford/AstraZeneca vaccine will have serious implications for massive African vaccine rollouts planned by both the WHO co-sponsored COVAX facility as well as the African Union’s dedicated African Vaccine Acquisition Task Team (AVATT).

“The events this weekend, with South Africa suspending the AstraZeneca vaccinations and seeking new information and advice from the manufacturer and European medicines regulatory agencies, is exactly what we wanted to avoid in our call to action,” Ellos Lodzeni, Treasurer of the IAPO Governing Board and founder of the Patient and Community Welfare Foundation of Malawi, told Health Policy Watch.

“This has left vaccination programmes in the rest of Africa in a limbo. The African Medicines Agency could have been that competent pan-African medicines regulatory agency that could have resolved this matter very early. The African Union must have a competent regional medicines regulatory agency that can help us build back better faster and safer,” Lodzeni said.

Additionally, establishing the AMA could improve country participation in clinical research and scientific innovation, boost manufacturing capacities, and allow for greater collaboration and knowledge sharing.

While progress has been made over the past couple of months on increasing the ratification of the Treaty, less than half of countries that have signed it have ratified it and established it as part of their national law. Only eight countries have ratified the agreement – Rwanda, Mali, Burkina Faso, Ghana, Seychelles, Guinea, Morocco, and Namibia.

Leading southern and eastern African nations, such as South Africa, Kenya, Uganda, and Tanzania, along with Cameroon, Nigeria, and Egypt have yet to sign onto the Treaty. 

Regional Challenges and Aims of the AMA

Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to the African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD).

Weak regulatory systems have led to the circulation of falsified or substandard products, which pose a risk to public health and undermine confidence in health systems. The current network of separate national regulatory authorities has resulted in slow processes for new medicines to be approved by each country – time that is severely lacking during a public health emergency.

“No single country has enough resources and capability to efficiently and effectively regulate the whole supply chain system alone in this globalised world,” said Karim Bendhaou, who heads Africa Affairs for Merck and is chair of the IFPMA’s Africa Engagement Committee.

The main aims of the AMA are to:

  • Strengthen and harmonize efforts of regional health organizations and member states;
  • Provide evidence-based scientific regulatory decisions and guidance;
  • Improve patients’ access to effective, safe and quality medicines; 
  • Minimize administrative hurdles; and
  • Manage the prevalence of substandard and falsified medical products. 

A strong, unified regulatory system could coordinate market surveillance for falsified and substandard medical products, centralize information collection and sharing, strengthen national efforts to improve access to safe and innovative products, and optimize healthcare systems. 

“The establishment of the African Medicines Agency is a critical next step to enable all patients in Africa to have timely access to quality medicines that are safe and effective,” said Adam Aspinall, chair of the Fight the Fakes Alliance. 

-Updated on 9 February

Image Credits: Interpol, IFPMA.