WHO Director General Tedros Adhanom Ghebreyesus greets Afrigen CEO Petro Terblanche.

CAPE TOWN – “Our baby is in good hands and will get stronger,” World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus told Afrigen CEO Petro Terblanche during a visit to the South African company which was chosen by the WHO as a “hub” to make mRNA vaccines and then share the technology with other countries.

Tedros, accompanied by Meryame Kitir, Belgium’s Minister of Development Cooperation and Urban Policy, met a phalanx of South African officials during a tour of the hub and related facilities at the forefront of the country’s COVID-19 response on Friday.

The mood of the delegation was celebratory as Terblanche’s facility has recently completed an mRNA vaccine based on Moderna’s ‘recipe’, and is preparing for this vaccine to go enter clinical trials.

Tedros said that the WHO believed that the acute phase of the COVID-19 pandemic will end this year, but only if 70% of the global population is vaccinated.

“More than half of the world’s population is now fully vaccinated, and yet 84% of the population of Africa is yet to receive a single dose,” said Tedros.

“Much of this inequity has been driven by the fact that globally, vaccine production is concentrated in a few mostly high-income countries. One of the most obvious lessons of the pandemic is the urgent need to increase local production of vaccines, especially in low and middle-income countries,” said Tedros, explaining that this was why the WHO had decided to set up a hub to develop and share mRNA know-how for this pandemic and other diseases.

The central aim is to develop a training facility where mRNA technology is developed to the scale required for mass production of vaccines and then for that full package of technology to be transferrable to multiple recipients in low- and middle-income countries.

Tedros shrugs off BioNTech report

“If the owners of mRNA vaccine technology share their knowledge with the hub, we could expedite manufacturing, removing the need for large political trials and cutting development and approval time but at least one year,” said Tedros.

Tedros shrugged off a report that a BioNTech-related company had tried to undermine the mRNA hub, instead promoting a fill-and-finish operation for the Pfizer-BioNTech vaccine involving Europe and a South African company instead.

“To be honest, we need both,” he added. “They’re partnering with countries – I think three countries who would like to start with fill and finish start production – and have increased the availability of vaccines. Is that bad?  It’s not. It’s good,” but he appealed for them to also share their technology with the mRNA hub.

However, South African Health Minister Joe Phaahla said that half the country’s vaccine stock was bought from BioNTech-Pfizer and it would be “worrying” if the company wanted ti undermine the hub.

“We will not actually allow any private company to protect its interests by preventing others from accessing knowledge and know-how,” said Phaahla.

Meryame Kitir, Belgium’s Minister of Development Cooperation and Urban Policy, and Dr Tedros.

Better than TRIPS waiver, says Belgium’s Minister

Kitir described Afrigen’s vaccine development as a “breakthrough”, and said that the hub is “showing the world how to solve the fight against inequality”.

Belgium, France, Germany, Norway and the European Union have invested heavily in the mRNA hub, which is estimated to cost $100-million over the next five years.

“We must look beyond charity and seek structural solutions,” Kitir urged. “Donations are still important, but more is required, and that is why I have invested in projects that increase the local productions of vaccines, and I’m proud of this initiative in South Africa.

“The position of Belgium is that vaccines should be a public good. We have been having discussion about patent waiver for two years and the only conclusion that we can say today is that everyone is open for dialogue,” added Kitir. Belgium, which is home to many biotechnology companies, has been reluctant to support the TRIPS waiver proposed by South Africa.

Kitir said that the hub was a “better solution than the patent waiver because you make the country self resilient, and there is a there is a formula and it is open”.

When asked whether Belgian biotech companies were likely to support the mRNA hub and share their knowledge, Kirir could only name one – Universal Pharma – that had been in touch with Afrigen, adding that it was working in Senegal to share its know-how on vaccines.

According to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents pharmaceutical companies around the world including Pfizer and Moderna, South Africa’s hub “adds to the options companies may choose in developing partnerships and needs to be weighed against an increasingly crowded landscape of other initiatives, including their own network of manufacturing partners”. 

However, it asserted that “experience has shown that technology transfers have higher chances of being successful if they are bilateral, business-to-business and voluntary”.

South Africa offered clear leadership

“I congratulate South Africa leadership throughout the pandemic in hosting this mRNA technology transfer hub, in chairing the ACT accelerator Facilitation Council and in initiating a resolution at the World Trade Organisation to temporarily suspend intellectual property rights on COVID-19 products. President Ramaphosa’s leadership was very clear continentally and also globally with leadership in ACT Accelerator facilitation council,” said Tedros.

For most of 2021, limited global vaccine supply led to huge disparities in COVID-19 vaccine access, leaving billions of people – especially in low- and middle-income countries – unprotected against serious disease and death from COVID-19. Low levels of vaccine coverage also provided the ideal conditions for new variants to develop.

While supply has now increased, access to any new formulations of COVID-19 vaccines – tailored specifically to new variants – will likely also be inequitable because manufacturing capacity remains limited to only a small handful of companies and countries.

 

 

 

 

 

 

 

 

Image Credits: WHO, Kerry Cullinan .

South African Health Minister Joe Phaahla, second from right, with WHO Director General Dr Tedros Adhanom Ghebreyesus (centre) at Stellenbosch Faculty of Medicine, a member of the WHO co-sponsored new mRNA vaccine hub, on 11 February

Speaking during a tour by WHO’s Director General of Cape Town’s new mRNA vaccine R&D hub that replicated the Moderna COVID vaccine, South Africa’s Health Minister affirms support for the continental-wide medicines regulatory authority. 

CAPE TOWN  – South Africa’s Health Minister signalled that his country intends to join the African Medicines Agency – but that the treaty’s ratification has to be approved by the country’s parliament. 

Speaking during a triumphal tour of top WHO officials Friday to the Cape Town research institutions credited with replicating the Moderna mRNA vaccine recipe, Dr Joe Phaahla, affirmed that: “There is no, in principle, hesitation. It’s more operational in terms of making sure that we do sign the Treaty on the African Medicines Agency. 

But he said that the treaty ratification could still be a “lengthy process” because it has to go through the legislative process: “It’s got to be processed through our parliamentary process and be approved.  So we will be following up in terms of just making sure that this process is concluded in our legislative processes.

“As you all know our president has been leading not only on the issue of access to vaccines, but also to diagnostics and therapeutics. 

“We are committed to a continental, Pan African approach in terms of sharing knowledge, sharing resources and technical note.

While some 30 countries have signed or ratified the treaty on the AMA, most of Africa’s largest countries and economies have not yet done so. The holdouts have included Nigeria, Kenya, Ethiopia and South Africa. Egypt and Senegal have, on the other hand, signed and ratified the treaty.   

WHO DG expresses AMA support during tour of Cape Town mRNA hub   

WHO Director General Dr Tedros Adhanom Ghebreyesus visit Cape Town’s new mRNA hub

WHO’s Director-General Dr Tedros Adhanom Ghebreyesus also appealed to African countries to join the AMA during a widely-publicized trip to Cape Town to celebrate scientists’ breakthrough there in replicating mRNA COVID vaccine technology.

“All African countries should support the rapid establishment of the African Medicines Agency,” said the WHO DG at a press briefing after he toured Afrigen Vaccines and Biologic’s R&D facility as well as Biovac, where the first batches of the new vaccine are to be manufacturered to GMP standards.    

Lab technicians at work in Cape Town’s Afrigen Vaccines & Biologics, during a high level tour 11 February by WHO officials. The company says it has replicated Moderna’s mRNA vaccine.

“Common platforms or institutions are important – because there are many shared issues in our continent that has to be addressed through unison. The Africa Medicines Agency is one of them.  

“The experience from the European Medicines Agency is that it helped actually in bringing the whole [European] Union together even in reducing the funding they invest in individual approvals because the approvals cuts close to at the country level approval that’s done.

He added that particularly in a pandemic, “every country cannot fight this cross border so the African Medicines Agency can help fight this also.”

“I believe that this institution will be very, very important for the continent.”

Africa CDC also was resisted initially – now has full-fledged support

Tedros compared the evolution of the AMA to the course taken by Africa Centres for Disease Control and Prevention – an idea he says he initiated during his term as Ethiopia’s foreign minister.

“When I proposed the Africa CDC in 2017 in Abuja, some people laughed at me,” he observed.  “…Now I see continent-wide support to Africa CDC, but it took many years for many people to understand its benefits.

“So I see the same thing with him with AMA, the same resistance and the same doubts and the same concerns.

“I know Africa Medicines Agency will be as beneficial as the Africa CDC. So I would like to use this opportunity actually appeal to all countries who haven’t ratified to ratify, to speed up the establishment,” he said.  

Along with helping to speed up medicines approvals, the AMA can also play a role in stimulating manufacturing in Africa, he added, linking to the focus of his tour Friday of the Cape Town’s new mRNA vaccine hub. “I think we need to identify institutions that can bring us all together… that’s why the continental and global institutions are more important than before.”

See our special covereage of the African Medicines Agency Countdown here:

African Medicines Agency Countdown

 

Image Credits: @elmimuller, WHO, Rodger Bosch for MPP/WHO.

Matshidiso Moetic, WHO Regional Director for Africa

A partnership between Africa CDC and MasterCard Foundation, which has included visits to countries with model vaccination programmes, such as Rwanda and Morocco, is making a difference to other African countries facing challenges in getting jabs into arms.  

That and other measures aimed at supporting more rapid African roll out of COVID-19 vaccines are proving effective, said Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) on Thursday. 

Meanwhile, WHO African Regional officials said that only 0.5% of COVID-19 vaccines received on the continent had actually gone to waste  — despite the fact that another recent  report suggesting that up to 35% of doses so far received are still awaiting distribution. 

Addressing journalists on Thursday, Nkengasong said the Saving Lives and Livelihoods initiative —  involving Africa CDC and MasterCard Foundation — have demonstrated results in at least four countries so far. 

“We have data from Sierra Leone, South Sudan, Cameroon and Tanzania where uptake of the vaccination really increased significantly once we sent in teams as part of the initiative,” Nkengasong said.

Delegations from those and other countries visited Morocco and Rwanda, where about 63% and 55% of the population respectively have been fully vaccinated, to learn about their model for success, he said.

“A set of countries, about 16, have actually been to Morocco to see their experience. Another set was in Rwanda. And as we speak, micro planning is going on for about 40 countries in Africa as part of that initiative,” Nkengasong told Health Policy Watch.

Along with site visits, the initiative is supporting countries to review their procurement processes; develop and finalize rollout plans; and ensure faster deployment of vaccines that are due to expire soon. 

 0.5%  Wastage 

africa cdc
Airfinity estimates of donated doses that have actually been adminsitered

On Wednesday, Health Policy Watch reported that only 65% of donated COVID-19 vaccine doses have been administered so far – with the remaining 35% yet to be used.  The largest proportion of donations, although by no means all of them, have gone to countries in Africa. 

However, Dr Richard Mihigo, WHO Africa Coordinator of Immunization and Vaccine Development, said that while there may be doses still awaiting distribution, actual wastage remains very small. 

Out of 635 million doses received so far, wasted doses have amounted to only about 3.5 million, representing only about 0.5% of the doses received, Mihigo said.

“If we look at the bigger picture, the continent has not done that bad at 0.5%,” Mihigo said.

He noted that the wastage that has occurred, is also due to the fact many donated doses have also arrived too close to their expiration date – making rapid rollout a huge challenge.

“So we cannot really condemn African countries because if you look at developed countries, we have also seen vaccines that have been destroyed,” Mihigo added.

To further ensure that vaccines are not being destroyed by African countries, Mihigo said the COVAX initiative has updated its engagement with African countries, ensuring that it only supplies the amount of doses requested by the countries according to their timelines — responding to country demands instead of pushing out vaccines through a top-down agenda.

“I think that the prospects in the future are looking quite good because countries are requesting vaccines that they can use. 

“But, also, WHO, UNICEF, GAVI, Africa CDC, are also putting out a strong statement on vaccines for each country to only receive vaccines that have a quite extended shelf life so that the country can be able to plan and deliver those vaccines on time,” he said.

Despite spread of new Omicron sub-variants, Africa on track to control COVID-19 pandemic in 2022

Meanwhile, Nkengasong, in his briefing, confirmed that the more infectious Omicron BA.2 subvariant now has become dominant in South Africa – and is slowly spreading elsewhere on the continent – after first being detected last month in Denmark and India. However, while the subvariant appears to be even more infectious than the original Omicron, experts have said it is not more deadly.  See related Health Policy Watch story. 

But WHO’s Regional Director for Africa, Dr Matshidiso Moeti, did not express undue concern over the continued mutation of the SARS-CoV2 virus, saying that Africa is on track to control COVID-19 pandemic in 2022 if current trends continue.

She said that over the past two years, African countries have become smarter, faster and better at responding to each new surge in cases of COVID-19.

“Against the odds, including huge inequities in access to vaccination, we’ve weathered the COVID-19 storm with resilience and determination, informed by Africa’s long history and experience with controlling outbreaks. But COVID-19 has cost us dearly, with more than 242, 000 lives lost and tremendous damage to our economies,” Moeti said.

While admitting that COVID-19 will be around for the long-term, she noted that there is optimism as 2022 can see the end of the disruption and destruction the virus has left in its path, and gain back control over lives on the continent. 

“Controlling this pandemic must be a priority, but we understand no two countries have had the same pandemic experience, and each country must, therefore, chart its own way out of this emergency,” she said.

The Rwanda experience

Albert Tuyishime, Head of Diseases Prevention and Control at Ministry of Health/Rwanda Biomedical Centre

The East African country of Rwanda has been recognised as one of the African countries that has been a model of vaccination progress. With 54% of its eligible population fully vaccinated – Rwanda has raced ahead of more developed South Africa – and ranks only second to Morocco in terms of coverage.   

Speaking at the Thursday Africa CDC briefing,  Dr Albert Tuyishime, Head of Diseases Prevention and Control at Ministry of Health/ Rwanda Biomedical Centre talked about how the country had achieved those results – driven by the highest level of the country’s leadership. 

“We also built on in-country multisectoral collaboration, effective partnerships, regional collaboration, and, especially, community engagement and research, science- and evidence-based decisions as well as interventions,” he said.

He noted that 66% of the Rwandan population had been vaccinated with at least one dose while 55% have received two doses, and 8% of the population have already received their booster dose. In addition, the country is now expanding vaccine access to children aged 5 to 11 years.

Image Credits: https://mcusercontent.com/2fe57162f164ecead64629b83/files/1d4e2b0b-bbe2-6050-0281-6e10c66eb3b2/1_billion_donated_v2.pdf?utm_source=Airfinity&utm_campaign=d1db73af86-EMAIL_CAMPAIGN_2021_08_02_12_31_COPY_01&utm_medium=email&utm_term=0_41a531e556-d1db73af86-517334173.

A molecular model of the Omicron subvariant BA.2

The BA.2 sub-variant of Omicron is now the dominant COVID-19 variant in South Africa, the head of Africa’s Centers for Disease Control and Prevention (CDC) confirmed on Thursday – raising questions about whether the continued global creep of the new SARS-CoV2 sub-variant could dash hopes of a much-needed COVID-19 reprieve.

“We have data from South Africa that the BA.2 lineage has now become the predominant variant in South Africa,” said Africa CDC director John Nkengasong at a regular online media briefing.

He added that the variant had already been detected in Botswana, Kenya, Malawi, Mauritius and Mozambique – and is likely present in other parts of the continent, as well.  That follows earlier reports from Europe, notably Denmark, and India where BA.2 is also overtaking the BA.1 version of the Omicron variant – becoming the latest variant to watch around the globe.

BA.2: Omicron’s ‘stealth’ sub-variant

Artist’s rendition of SARS-CoV2

The World Health Organization began monitoring BA.2 weeks ago, alongside other “sister” or “daughter” variants of the Omicron: BA.1.1 and BA.3. But BA.2 has been referred to as the “stealth” sub-variant because it has genetic mutations that could make it harder to distinguish from the earlier Delta variant, as compared to the original Omicron, according to the American Medical Association.

WHO already classified Omicron as a SARS-CoV2 variant of concern – alongside Alpha, Beta and Delta. Since BA.2 is “related” to Omicron, it is also a variant of concern.

Variants of concern, otherwise known as VOCs, are those variants about which WHO has enough data or signs to be concerned and warn the public to take extra care, explained Dr. Dorit Nitzan, former Coordinator of the Health Emergencies for WHO’s European region. 

“I would probably call it a sister,” Prof William Moss, Executive Director of the International Vaccine Access Center at Johns Hopkins University in Baltimore, told Health Policy Watch. “This sub-variant has actually been around for a long time. It was identified around the same time as BA.1 and so they are obviously genetically related like siblings. But we don’t really know the temporal sequence in which these variants evolved.”

What scientists do understand is that BA.2 is more transmissible, based on evidence that has emerged from India, Denmark and now South Africa, where BA.2 is becoming dominant in these settings – countries where BA.1 was most prevalent.

Last month, Danish scientists reported that BA.2 was around 33% more transmissible than the original Omicron strain.

“We conclude that Omicron BA.2 is inherently substantially more transmissible than BA.1, and that it also possesses immune-evasive properties that further reduce the protective effect of vaccination against infection,” the study’s researchers said.

BA.2: More transmissible, not deadlier

Other studies have found the variant to be as much as 50% transmissible, Nitzan said, though she added that the percentage does not really matter. What is important to know is that you can get infected faster.

Before WHO labels a variant a VOC, it first classifies it as a “Variant of Interest” or VOI, meaning that scientists are tracking the variant, but still learning about it.

“WHO is following many variants in many different lineages,” Nitzan told Health Policy Watch. “We know that many of them are not going to be developed.”

Omicron, however, is a variant that did develop and “it now appears to have its own little family,” she added:

“I think it could happen that just about everyone will have COVID,” Nitzan said. “It can happen if we cannot protect ourselves with masks, social distancing and good hygiene.”

And, of course, vaccination.

Moss said that while BA.2 is more transmissible, the good news is that it does not appear to cause more severe disease than the original Omicron strain, especially in people who have been inoculated. While vaccine effectiveness against Omicron infection appears much lower than what was seen against previous variants, it does still seem to be keeping most people out of the hospital.

He added that “the emergence and spread of BA.2 is not going to dramatically impact the course of the pandemic in the United States or European Union. It may just prolong it a bit.”

NeoCoV: ‘More attention than it deserves’

The research team prepares to gather samples from a dromedary camel in surveillance of MERS.

Another coronavirus discovered in bats last month has raised the eyebrows of some scientists: NeoCoV, a new bat coronavirus, was identified in South Africa.  It is of concern because it is closely related to the deadly MERS-CoV virus that has caused limited outbreaks since 2012 in countries around the Arabian Peninsula, where the virus is typically transmitted to humans from camels.

However, unlike MERS,  NeoCoV uses an ACE-2 receptor to infect cells  – the same mechanisms that has made SARS-CoV2 so infectious.

To date, no cases of NeoCoV have been reported in humans.

However, one pre-print study led by scientists associated with Wuhan’s Institute of Virology, warns that the NeoCoV virus could be on the threshold of human infectivity – due to its uptake of the ACE-2 receptor gene.

“Our study demonstrates the first case of ACE2 usage in MERS-related viruses, shedding light on a potential bio-safety threat of the human emergence of an ACE2 using “MERS-CoV-2” with both high fatality and transmission rate,” states the study, published in late January 2022.

“Notably, the infection could not be cross-neutralized by antibodies targeting SARS-CoV-2 or MERS-CoV,” the paper also adds.

The study also notes that NeoCoV has certain genomic characteristics of MERS-CoV, which was 20 times more deadly than the SARS-CoV2 Delta variant, for example –although much less transmissible.

“This unexpected ACE2 usage of these MERS-CoV close relatives highlights a latent biosafety risk, considering a combination of two potentially damaging features of high fatality observed for MERS-CoV and the high transmission rate noted for SARS-CoV-2,” the report said. “Furthermore, our studies show that the current COVID-19 vaccinations are inadequate to protect humans from any eventuality of the infections caused by these viruses.”

Notably, Wuhan’s Institute of Virology has been under international scrutiny for months due to suggestions from some international virus experts that a biosafety lapse at the laboratory that studies bat coronaviruses could have been the cause of the original Wuhan SARS-CoV2 leap into human populations.  That narrative has been  disputed by other experts who point to wild food chain sources as the  more likely original cause of infection – and even more adamantly by official Chinese sources, who have also sought to point attention to SARS and SARS-like virus threats elsewhere in the world.

A new WHO SAGO group of experts began meeting late last year to explore the narratives further – although China has not agreed to allow a second expert mission to enter the country  to further investigate the SARS-CoV2 virus origins.

Moss, however, said that in his view, NeoCoV is getting more attention than it deserves.

“There is no evidence that it can be transmitted from bats to humans,” Moss said. “My takeaway from NeoCoV is just a reminder that there are a wide-range of potential viruses with potential to cause spillover events.”

Image Credits: Delthia Ricks/Twitter, Trinity Care Foundation/Flickr, NIAID/Flickr.

Shipment of Sinopharm to Peru

While China’s rigorous management of virus risks at home has received considerable attention, particularly as it hosts the 2022 winter Olympics, it’s massive vaccine effort abroad has been underreported. In fact, as of end 2021, Beijing had supplied more COVID vaccines to low- and middle-income countries than the WHO co-sponsored COVAX facility. 

Against the constant press scrutiny of global rollouts of vaccines from the big name western pharma companies, like Pfizer, Moderna and Oxford/BioNTech, China’s major role in increasing COVID-19 vaccine coverage globally has been largely overlooked – by the global health community  as well as donors. 

In fact, as of end 2021, Beijing had supplied nearly 1.3 billion doses to low- and middle-income countries – more than the WHO and Gavi co-sponsored COVAX global facility, which has so far relied mainly on vaccines licensed by Western countries. 

Moreover, manufacturing of Chinese vaccines has been further expanded through co-production partnerships with a number of middle-income countries. 

However, unlike COVAX, the overwhelming majority of  the Chinese vaccines have been sold, not donated. And while Chinese supplies have reached a total of its 98 countries, in terms of absolute volumes, most doses have been supplied to a smaller handful of, mostly upper-middle income, countries. 

Source: Based on data on COVID-19 Vaccine Access from Global Health Centre 2021

At the same time, while COVAX has approved procurement of two Chinese vaccines, Sinopharm and Sinovac in 2021, China has generally preferred bilateral deals. In fact, Chinese doses supplied through COVAX accounted for only about 110 million of the 1.26 billion doses that it has sold or donated abroad in 2021.  

So while China’s role has been critical in filling the global vaccine supply gaps, it has operated largely outside of the multilateral architecture that WHO, GAVI and other global health agencies have sought to create during the pandemic. 

Recognizing this has important implications for the future of the established global health system, and how China may choose to engage, compete with or complement it.

Our analysis considered production and export patterns for the four Chinese vaccines, which have the most extensive international footprint, based on publicly available data up until October 2021. Additionally, we found that China’s COVID-19 vaccine landscape was characterized by: 

  • Extensive Chinese partnerships in sales and manufacturing with LoMICs; 
  • Prioritization of recipient countries that are part of China’s massive Belt and Road Initiative; 
  • A nearly 50-50 split of investments by Chinese private and public sectors in the R&D initiatives that produced the vaccines. 

Two billion doses…. 

Vaccine inequality has been constantly highlighted as the culprit of prolonging the COVID-19 pandemic, costing more lives, slowing down the economic recovery, and leaving the world constantly ravaged by new variants. It has been a constant message of WHO Director General Dr Tedros Adhanom Ghebreyesus, including in his meetings this week with Chinese leaders at the start of the winter Olympics. 

In August 2021, China pledged to provide 2 billion vaccine doses for countries across the world by the end of this year. Our analysis found that, as of October 2021, China had either exported or donated 1.26 billion doses, surpassing the 1 billion dose distribution goal set by COVAX for 2021. But the vast majority of those were via sales, with a large proportion of the vaccines went to middle-income countries, with the upper-middle income Brazil and Indonesia in the top spots, followed by sales to COVAX.

Source: Based on data on COVID-19 Vaccine Access from Global Health Centre 2021

UMICs as main purchasers of exports

china sinopharm
Shipment of Sinopharm vaccine to Barbados

Altogether, some 58.76% doses of Chinese vaccines were exported to 29 upper middle-income (UMIC) countries; 23.37% to 24 lower middle income (LoMIC) countries;  6.50% to 9 high-income countries (HICs); and 2.55% to 4 low-income countries (LICs). 

In terms of country-specific data, the top 10 biggest importers include Brazil, Indonesia, Turkey, Bangladesh, Mexico, Chile, Iran, Peru and Morocco.  

Notably, only 110 million doses were sold to COVAX, which accounts for merely 8.82% of the grand total.  In addition there were some 58.2 million donated doses to 93, mainly lower-income countries as well as UN peacekeepers.

Compared to its sales, donations of doses have been a small portion of China’s portfolio, totalling less than 60 million doses out of the total of the 1.26 billion doses exported abroad in 2021. 

Interestingly enough, some three quarters (74.2%) of those donations have gone to some 42 lower-middle income countries, as compared to only about 11.78% of donations to the world’s low income nations. 

In addition, some 12.30% of vaccine doses went to 26 upper middle income countries, and 1.21% of donations even went to 7 high income countries like Hungary.  

Source: Based on data on COVID-19 Vaccine Access from Global Health Centre 2021

Targeted recipients, especially the Belt-and-Road Initiatives

While pledging to make Chinese vaccines a global public good, China has also taken the opportunity to use vaccines as part of its broader diplomatic initiatives. 

In particular, China’s ‘Health Silk Road (HSR)’ initiative has prioritized members of its economic Belt and Road initiative for donated vaccine doses. 

For instance, in terms of total number of doses donated, the top 10 biggest recipients in 2021 were Cambodia, Bangladesh, Sri Lanka, Pakistan, Myanmar, Nepal, Laos, El Salvador, the Philippines, and the West Bank and Gaza. Of those, all but the West Bank and Gaza are members of the BRI. 

Countries in China’s Belt-and-Road Initiatives

Scaling up manufacturing partnerships overseas 

Extensive cooperation has been carried out to scale up manufacture of Chinese vaccines overseas. A total of 17 manufacturing agreements with 15 countries were identified, with the sum of anticipated production per year amounting to nearly 2 billion doses. 

Manufacturing partners are mainly concentrated in lower-middle-income (LoMICs) and upper-middle-income countries (UMIC), and several countries have established partnerships with more than one Chinese vaccine developer: Egypt is in the lead in projected production capacity, followed by Indonesia, the UAE, Russia and Brazil. Notably, among the top five largest foreign manufacturers, four are part of the Belt and Road Initiative (BRI).

Significant Chinese private sector vaccine R&D investment

Overall, our database identified over US$ 1 billion of investments into Chinese vaccine R&D. Strikingly nearly half of the financial R&D contributions came from the private sector, while slightly more than half was public sector funding. 

This is in contrast to other global research by the Graduate Institute’s Global Health Centre suggesting that globally, public sector funding for COVID vaccine R&D accounted for more than 90% of the total vaccine R&D investment that could be tracked publicly, as of July 2021.

Chinese private R&D investors included companies such as Advantech Capital, Vivo Capital and China Evergrande Group. Apart from that, China National Pharmaceutical Group (CNPG) spent 145 million USD in developing its Sinopharm vaccines. Philanthropic organizations account for only 3.85% of the total.

Distribution of R&D investments in COVID-19 vaccines in China

 However, given the relatively limited data on research and development (R&D) investments into Chinese vaccines so far, it is difficult to draw a comprehensive picture.

In addition, given the close relations between the public and private sectors in China, such a funding distribution pattern should be interpreted with caution, and the proportion of the investment made by the public sector may well be severely underestimated.

China and COVAX

To better understand China’s role in increasing global vaccine coverage, it is interesting to  compare and contrast with COVAX, the global collaboration of WHO, Gavi the Vaccine Alliance and other partners to advance equitable access to COVID-19 vaccines. 

COVAX first set its initial goal as 2 billion vaccine doses available by the end of 2021, but cut its supply forecast by around 25% to 1.4 billion in September, and then again in December down to 800 million to 1 billion doses. The latest data from the UNICEF COVID-19 Vaccine Market Dashboard is that around 1.1 billion doses have been shipped so far by late January, 2022. 

Nevertheless, COVAX has supplied 144 countries with a mix of donations and sales, while China has provided doses to 115 countries with around 95% of doses via sales. Moreover, despite the wide coverage of LoMICs destinations with donated doses, the major chunk of Chinese vaccines are, in effect, supplied to upper middle income countries, which differs from COVAX’s focus on low income and lower-middle income nations in particular. Along with that, however, China sold 110 million doses to COVAX, which presumably reached a broader range of COVAX target recipients. 

New Chinese Pledge to Africa in 2022 

Sinopharm vaccines to Zimbabwe

In 2021, in conclusion, the massive role played by China in expanding developing countries’ access to vaccine doses and technology, met the needs of middle income countries in particular. 

China’s active engagement with countries of the Belt and Road Initiative with regards to vaccine manufacturing, donations, and purchases, reinforced other economic and strategic initiatives underway.  

However, there are signs that China is also now looking at the broader picture of unmet needs in the lowest income countries – albeit again through mostly bilateral deals. 

In late November, amid growing concern over the spread of the Omicron variant, China pledged to deliver another 1 billion doses of COVID-19 vaccines to Africa   in 2022, which will mostly be through bilateral deals, with two thirds as donations and another third likely through joint production agreements. 

This would further enhance China’s large-scale role in increasing COVID vaccine coverage in Africa, the least covered region of the world.

However, African nations now have many other vaccines to choose from. 

And there are growing concerns among professionals about the relatively high COVID mortality rates seen among people vaccinated with Sinovac and Sinopharm – recently reported in Singapore. This has cast further doubts on the vaccines’ overall efficacy, which was always rated lower than most of its western competitors. 

Even so, China’s massive vaccine and manufacturing export can be expected to continue.  Understanding the global COVID-19 vaccine landscape requires taking that into account. 

In 2022 it will be important to continue tracking not only of Western vaccine manufacturers and suppliers, but also China’s massive role – in terms of supply, distribution as well as  efficacy data in light of the continually evolving SARS-CoV2 virus variants. Doing so also sheds light on potential future directions in global health diplomacy China will play in the next phase of pandemic recovery.  

Xiaoyi Wang, a Master in International Affairs (MIA) candidate specializing in International Trade and Global Health at the Graduate Institute of International and Development Studies (IHEID).

With thanks to Suerie Moon, co-director of the IHEID Global Health Centre, for her comments and contributions to the analysis. 

Image Credits: Contraloría Perú, Xiaoyi Wang, Xiaoyi Wang , Council of Foreign Relations, Twitter – Chinese Ambassador to Zimbabwe.

A Maltese-based foundation representing BioNTech, the German company that co-produced with Pfizer a highly successful mRNA COVID vaccine, has been accused of seeking to undermine the World Health Organization’s new initiative to promote an open-source African-based COVID vaccine manufacturing hub – while proposing to ship European-fitted mRNA vaccine facilities to Africa in sea containers as an alternative, according to an investigation published by The BMJ.

The kENUP Foundation, a consultancy hired by BioNTech, reportedly advocated against the new WHO-sponsored Technology Transfer Hub in Cape Town, South Africa, which aims to train African researchers and entrepreneurs im making patent-free versions of mRNA vaccines. kENUP argued that the venture is unlikely to be successful and will infringe on patents, documents obtained by The BMJ suggest.

kENUP sought to advance an alternative proposal to ship fully-equipped mRNA factories housed in sea containers from Europe to Africa, and initially staffed with BioNTech workers.  Along with that, it proposed a new regulatory pathway to approve the vaccines made in such offshore factories. The initiative was described as both paternalistic and unworkable by experts interviewed by The BMJ.

The BMJ investigation reveals details of the proposal from kENUP and BioNTech and their criticism of the WHO venture.

The kENUP Foundation did not directly address the allegations or respond to The BMJ’s questions about the affair.  BioNTech said in a statement that its plans to establish mRNA based vaccine manufacturing on the African continent “will be done in close alignment with the WHO, the African Union, and the African CDC.” Pfizer has, meanwhile, announced preliminary agreements to construct vaccine manufacturing facilities on African soil, in Rwanda and Senegal. Asked by Health Policy Watch to comment on the kENUP venture, pharma observers in Switzerland said that the kENUP initiative was perceived an industry outlier. On Friday, WHO’s Director General Dr Tedros Adhanom Ghebreyesus is set to visit the Cape Town-based facilities of the new Technology Transfer Hub, including Afrigen Biologics & Vaccines, which may have now replicated the Moderna mRNA COVID vaccine.  The BMJ

Image Credits: Afrigen .

South Africa’s Competition Commission is pursuing prosecution against Swiss pharmaceutical giant Roche for “alleged excessive pricing” of its breast cancer treatment drug, Trastuzumab (marketed as Herceptin).

It estimates that some 10,000 women were unable to get the treatment they needed between 2011 and 2019 because of Trastuzumab’s cost.

It has asked the country’s Competition Tribunal to impose a “maximum penalty” against Roche, for its alleged harmful and life-denying pricing conduct,” in violation of the country’s Competition Act, says Competition Commissioner Tembinkosi Bonakele.

The commission described Roche’s pricing as “a violation of basic human rights” as it denies access to life-saving medicine for women living with breast cancer.

“The Commission has prioritized this case because the impact of excessive pricing of Trastuzumab falls heavily on women, particularly poor women, who cannot access essential treatment because they cannot afford to pay for it,” said Commission spokesperson Siyabulela Makunga.

Trastuzumab is a first-line treatment life-saving drug that stops the development of an aggressive type of breast cancer called Human Epidermal Growth Factor Receptor 2 Positive (HER2+) breast cancer. Trastuzumab stops the development of tumours and prevents cancer from spreading. 

The Cancer Association of South Africa puts the annual cost of treatment at around $32,000 – way out of the reach of most South Africans.

While Roche refused to share its cost data with the commission, the commission used biosimilar manufacturing cost estimates and prices to determine that the company’s pricing was excessive.

Rwanda
In March 2021, Rwandans lined up to receive the AstraZeneca COVID-19 vaccines. However, supplies stopped thanks to an export ban in India, paralysing Africa’s vaccination plans.

The WHO co-sponsored Act Accelerator Initiative, which aims to get 70% vaccine coverage to all countries by mid-2022, as well as more equal distribution of tests and treatments, tabled its latest  ask to donors – for some $16.8 billion in new funds – out of what it says would be a total cost of $48 billion to meet global equity targets. 

Speaking to journalists ahead of Wednesday’s launch of a new fundraising campaign, former UK Prime Minister Gordon Brown said that the funds would be crucial  to ending the pandemic in 2022.

However a report by the forecasting firm Airfinity, also issued on Wednesday, noted that some 35% of donated vaccine doses that have already been delivered to lower-income countries have not yet been administered. The assesment underlines the complexities faced on the ground in actually ensuring the uptake of COVID tools in countries and regions beset with multiple simultaneous health threats – and health services that are still facing considerable disruptions after two years of pandemic stress.

According to the ACT Accelerator which is a partnership of leading agencies that is providing the COVID tools to more than 90 low and lower middle-income countries, there is a US$ 16 billion ACT-Accelerator funding gap that needs to be filled by donors  That is not including $6.8 billion more needed for in-country delivery costs, which co sponsors of the initiative hope to meet from other sources, such as multilateral development bank loans.

Act Accelerator Ask for COVID treatments, tests and tools, alogn with in country delivery costs.

Closing that funding gap, ACT-Accelerator proponents say, will be important to ending the pandemic as a global emergency in 2022.  And those needs, totally some $23 billion, do not even include related costs for national procurement and hoped-for manufacturing scale up, which add up to another $25 billion – leaving a total investment cost of some $48 billion, according to the newly published ACT-A Investment case.

 

Gordon Brown, WHO Ambassador for Global Health Financing,

If the needed funding is not released, Brown added that the needed preventive actions may not be taken and this could put the entire world, including the rich countries, at a high risk.

“We urgently need the $16 billion because we do not fully fund preventative action yet. The disease will continue to mutate and do what could likely surprise us all. We urgently need the $16 billion because while future variants may be less lethal, they could also turn out to be more lethal, and it makes sense to be prepared,” Brown added.

With a mandate to overcome vast global inequities by providing low- and middle-income countries with access to COVID-19 tests, treatments, vaccines and personal protective equipment, ACT-Accelerator said it urgently needs new funding to scale up its work to develop and deliver the COVID-19 countermeasures essential to address the threat of Omicron and prevent even more dangerous variants from emerging.

“Prof John-Anne Rottingen, Norway’s Ambassador for Global Health Professor and Chair of the ACT-Accelerator Finance and Resource Mobilisation Working Group, said the specific sources of financing for the initiative are contributions from sovereign donors, LMIC governments’ domestic national resources and support from multilateral development banks (MDBs).

“The overall ask is $16.8 billion of the $23.4 billion budget. The remaining $6.5 billion we hope can be supported by MDBs as well as through domestic financing in middle-income countries. But in addition, I want to also highlight that this is not the total of the international COVID-19 response, there is an additional need for $24.6 billion. So in total, the COVID-19 response in 2022 is at $48 billion,” Rottingen said.

Among the additional $24.6 billion is in-country support which will support countries in delivering vaccines, tests and treatments. Rottingen said this will cost $6.8 billion and can be provided by international bilateral support in addition to the support for the ACT agencies, as well as support from the MDBs.

The fair share model

To raise the funding, a total of 55 countries have been written to and they include all high-income countries, G20 upper-middle-income countries, and two additional middle-income countries who are contributors to the ACT-Accelerator.

The ‘Fair share’ contributions were calculated for each of the countries and collectively cover the total immediate grant funding need of US$ 16.8 billion, assuming that the private sector and philanthropic institutions can cover US$ 0.5 billion. For the 2020-21 ACT-Accelerator budget, six countries (Canada, Germany, Kuwait, Norway, Saudi Arabia and Sweden) met or exceeded their fair share commitments.

Rottingen noted that they are using a model that was developed in the first budget cycle of the accelerator, and is based on a simplification of the International Monetary Fund quota formula with the main indicators being GDP as well as the openness of the economy. 

“And then adjusting that by GDP per capita to introduce a progressive element in the fair share model, and then finally adding a 20% risk buffer to ensure that we can meet the funding target of $16.8 billion,” he added.

The European Union is expected to contribute around a quarter of the needs, the rest of G7 will contribute 46%, the remaining members of the G20 will contribute 22% while 8% will be provided by other countries based on the fair share model.

Triumph of science, failure of politics

Carl Bildt, WHO Special Envoy for the ACT-Accelerator described the COVID-19 pandemic as a triumph of science but possible failure of politics considering the gross inequity in the availability of the means to fight COVID — vaccines, treatments and testing.

“It is not only morally appalling, it is also profoundly dangerous. If we don’t stop the pandemic, we might soon run out of Greek alphabets. We know that some variants might be more benign, but others might not be. And we all know that there’s absolutely no way of knowing which of the variants is coming next,” he said. 

Image Credits: WHO, https://www.who.int/publications/m/item/consolidated-financing-framework-for-act-a-agency-in-country-needs.

A child in Pakhistan getitng his polio drops.

As Afghanistan’s fragile health system battles for survival, hard-earned gains of the past 20 years in the tenacious battle against polio are under threat. But on a hopeful note, the new Taliban regime has just launched its first national polio vaccine campaign – reversing years of opposition to the life-saving intervention. 

Afghanistan witnessed the lowest ever polio transmission in 2021 providing what WHO officials have described at a recent Executive Board meeting as an “unprecedented” opportunity to interrupt transmission of wild poliovirus and ultimately achieve eradication. 

Only four cases of wild poliovirus type 1 (WPV1) were reported in the country last year.  Previously,  dozens of such cases would typically emerge. Leading up to this, two nationwide campaigns undertaken last year before the Taliban takeover in August 2021.  The campaign reached eight million children, including 2.6 million who were vaccinated for the first time. This has raised hopes for an end game for the crippling virus.

Taliban launch first-ever polio campaign – as Afghan health minister visits Geneva

Dr Qalandar Ebad, Acting Afghan Minister of Health

After years of opposition to vaccination, the Taliban government have pledged to maintain the momentum. The new Afghan government recently launched its first national polio immunization campaign for 2022, targeting 9.9 million children aged 0 – 59 months. However, the campaign is taking place against the continued spectre of hunger, humanitarian crisis and a “dire” health situation, according to WHO’s Director General Dr Tedros Adhanom Ghebreyesus.

Tedros met this week in Geneva with the Taliban’s acting Health Minister, Dr Qalandar Ebad, who arrived Sunday with a larger Taliban delegation, upon the invitation of the humanitarian group, Geneva Call, as part of an effort to unblock desperately needed humanitarian aid.

“Despite some improvements since then, the health situation in Afghanistan is still dire, and the acute humanitarian crisis is continuing to put lives at risk,” wrote Tedros in a tweet Wednesday, after Tuesday’s meeting.   Calling for continued dialogue with the Taliban, Tedros’ message also focused on the need to support Afghanistan’s COVID response and girl’s education. It was his  second meeting to date with the new Afghan health leader, following a visit by the WHO DG to Kabul in September 2021.

Taliban campaign reverses years of vaccine hesistancy

Desperately seeking international recognition and support, the Taliban-run Ministry of Public Health clearly now sees the uptake of polio vaccinations as an international and domestic win-win.  It has taken the lead in promoting polio vaccinations and convincing people to get their children vaccinated,  reversing years of vaccine hesitancy that characterised hardliners in the group.

In a televised interview this week, Ebad, a medical doctor by training, mentioned that immunization was among his ministry’s top priorities.

“Together with the international community, we would try our best to eradicate polio that is nearly diminished from Afghanistan. As a physician, I assure people that this is a disease that needs to be defeated on science-based international strategy, be it polio, measles or Covid-19 we would follow a global strategy,” he said. 

Afghanist & Pakistan are only countries remaining with wild poliovirus

Afghanistan and Pakistan are the only countries in the world that have been unable to stop endemic transmission of wild poliovirus, according to the World Health Organization (WHO). 

Pakistan has long blamed its polio cases on Afghan migrants and refugees, so Afghanistan’s battle is also one with high stakes for neighbouring countries who are concerned that any renewed outbreaks could spill over borders. 

While Afghanistan and Pakistan are still grappling with the wild poliovirus, the world is gearing up to roll out a new generation of polio vaccines to fight vaccine-derived polio cases that have been a problem in 27 countries in the African, Eastern Mediterranean, Europe and Western Pacific regions.

Finishing the eradication of wild polio in Afghanistan and Pakistan as well as advancing new vaccines to stamp out vaccine-derived polio cases in Africa, the Middle East and parts of Latin America and Asia,  were twin themes at the recent WHO Executive Board discussions on polio eradication – a health stream that is one of the largest in WHO’s budget. 

The discussions, which continued for hours, featured countries in Africa, Asia and the Eastern Mediterranean describing the challenges they face in rolling out a new generation oral polio vaccines to help wipe out vaccine-derived polio cases from older, less effective vaccine technologies – while remaining watchful of any risks from wild polio outbreaks. 

Ground Zero in the polio battle  

Last year, Africa was declared free of polio as a result of a determined 30-year effort. 

But in the fight against wild polio, Afghanistan remains ground zero in the battle. And the new immunization drive is taking place against the spectre of health worker protests that are stalling health service more generally. 

Evidently exhausted from relentless hours of duties, doctors and other frontline health workers have been on the street in a number of provinces protesting against the non-payment of salaries for months as the Taliban government struggles to manage budget flows amid the tough international sanctions imposed on it by the west.  

One protesting doctor based in the northern region of the country, Habibaullah Ahmadi, told the Health Policy Watch that he had not received his salary for 10 months now and was battling to survive. 

“We have decided to only continue work with few more days, but if we are still not paid our salaries, we will close the door of the hospitals because we all have families and we have a lot of problems, and we ask the international community to intervene and pay our due rights,” said Ahmadi.

Local authorities acknowledged the issue of non-payment of salaries, but blame the freeze on Afghan state reserves worth around $9 billion in the US for it. 

Recently,  doctors returned to work when the regional health head, Zaman Azami, assured the protesting health workers that their problems would be resolved ‘soon’.

The northern region of Afghanistan was the site of some of the deadliest clashes between the Taliban and the former government forces backed by  NATO, which resulted in disruption to the immunization drives last year and the emergence of most y of the new wild polio cases.

Although fighting has mainly ceased with the rise to power of the Taliban, the economic hardship that has followed has had an impact on the vaccination drives.

Meanwhile, the hardline Islamic State’s Khorasan (IS-K) chapter that recently claimed multiple deadly attacks in Afghanistan, continues to oppose the vaccination.

In the eastern provinces of Afghanistan marred by IS-K terrorism, at least four members of the polio vaccination team were gunned down and three others wounded last June. Back in March, three more members of polio vaccination team, all female, were shot dead by unknown assailants in the same area. 

Vaccine scepticism and attacks on vaccination teams

Children in Pakistan show proof of vaccination against polio.

Researcher and author, Ziaur Rehman, who has worked on polio campaigns for years, told Health Policy Watch that although the Taliban’s public stance on vaccinations has evidently changed, the mindset they nurtured against vaccinations during the past 20 years of insurgency will take years to address.

“If you remember it was broadly reported that the American CIA had used a Pakistani doctor, Shakil Afridi, to set up a fake polio vaccination campaign as a cover for the search for Al Qaeda chief Osama bin Laden in Pakistan. Ever since then, health authorities in Afghanistan and Pakistan have been struggling to win public confidence on the immunization,” Rehman said. 

A bunch of the Taliban splinter groups, particularly in the border regions between Afghanistan and Pakistan, continue to issue death threats to all those involved in the immunization campaigns despite the rise to power of the group in Kabul.

Echoing these concerns, senior Afghan paediatrician and former deputy director health, Dr Kabeer Ahmad told Health Policy Watch that scepticism towards polio and other vaccines still remain high, particularly in the rural communities. 

“If you go to the remote villages there are many people who still have serious doubts about the vaccine. It is in these communities, which also frequently travel between Afghanistan and Pakistan, that you see the virus transmitting.”

It is worth noticing that the WHO had said in a statement that Afridi was never part of any polio vaccination program in Pakistan – genuine or fake – and that baseless reports linking him to anti-polio efforts had damaged the ongoing vaccination campaign.

Remarkable progress

At the WHO Executive Board last month, WHO officials praised the “remarkable progress” in the fight against the virus in Afghanistan, and it was labelled as the “best opportunity” to end polio for the entire world. 

“To reach the final goal (of polio eradication). We need more of what we saw in 2021, the government leadership at all levels, and embedded access to children, informed and engaged communities and the highest quality of operations. And we need all of this to be sustained until transmission (of the virus) is interrupted, and the number of paralyzed children is at zero and kept,” said  Dr Ahmed Salim Saif Al Mandhari, WHO Regional Director for the Eastern Mediterranean Region, which includes Afghanistan and Pakistan.

The WHO has an estimated budget of $4.2 billion set aside for the five-year Global Polio Eradication Initiative 2019-2023 in partnership with UNICEF. The second component, starting in 2022, is the one-time cost of $121 million to have oral polio vaccine stockpiles (OPV) in place for use post-certification. Together, it brings the overall cost to achieve and sustain polio eradication to $5.1 billion

It was also underlined at the meeting that the world must not overlook the challenges that remain on this front such as the outbreaks of vaccine-derived polio viruses. 

Taliban seek international financial support

“I urge the member states to make domestic funding available to respond when needed, so that National Public Health capacities respond to outbreaks, as well as the COVID 19 pandemic, and are robust and can be integrated into broader public health services across steadily,” said Dr Al Mandhari, who also visited Kabul and met the Taliban leadership along with Tedros in September.

At the EB, many members state expressed commitment and support for the WHO’s immunization drive. It was stated that the financial support from the Global Polio Eradication Initiative will continue until the end of 2023 for the 10 countries at higher risk for polio, including Afghanistan while the 37 low-risk polio countries are being funded through the WHO based budget. 

After the assurance of funds by the international community, Ebad said that the immunization programs would cover the entire country rather than the 30-40% previous target.

The novel oral polio vaccine for type two, which received WHO’s first-ever emergency use listing in November 2020, has been introduced and delivered at scale in 12 countries using almost 200 million doses aimed at eradicating vaccine-derived polio transmission. 

The supply chain has since been strengthened with 640 million doses planned for delivery during 2022, according to the WHO. Still, at the Executive Board meeting of the WHO last month, the global health body’s chief, Tedros Adhanom Ghebreyesus warned against lowering guard against the crippling virus. 

“When there is success, we tend to lower our guard. So what I say is we need to be more aggressive, and we shouldn’t lower our guard. That’s what I say but eradicating polio is within reach,” said Tedros.

Image Credits: UNICEF Pakistan, Ministry of Public Health, Afghanistan.

Inside Afrigen’s R&D facility in Cape Town, South Africa – where scientists think they have copied Moderna’s COVID-19 mRNA vaccine recipe.

CAPE TOWN – The COVID-19 mRNA candidate vaccine, developed in two months flat by South African scientists based on Moderna’s “recipe”, might be too late for this pandemic, officials leading the project told Health Policy Watch, on the eve of a high-level WHO visit to the Afrigen Biologics & Vaccines facility where the vaccine formula was recently replicated.  

Still, the new WHO co-sponsored mRNA vaccine technology transfer hub based in South Africa aims to fill a longer-term mission, asserts Martin Friede, the WHO coordinator of the initiative in Geneva, in an interview with Health Policy Watch.  And that is to act as a “training hub” building out capacity for manufacturing cutting-edge mRNA vaccines in other low- and middle-income countries. 

And in the absence of a high-level commitment to support the mRNA hub from Moderna or Pfizer – other pharma partners with vaccine expertise have come forward, Friede said.

“I’m pleased to say that a few biotech companies have said we are prepared to share with you some of our knowledge about how to scale up,” said Friede, declining to name who those partners might be.

He and other officials spoke to Health Policy Watch on the eve of a planned visit here Friday and Saturday by WHO Director General Tedros Adhanom Ghebreyesus to Afrigen and other South African institutions collaborating in the new hub initiative. The visit by Tedros, accompanied by Belgium’s Minister of Development Cooperation, will likely bring more news of the expanding partnership around the hub.

Along with Afrigen, Tedros will also visit the Biomedical Research Institute, based at Stellenbosch University’s Tygerburg Medical Campus, and Biovac, among other collaborators in the new hub. While Afrigen is the R&D faciilty that is developing the vaccine, Biovac would provide for its manufacture, accoring to the WHO plan.

Meanwhile, at Afrigen, while the development of the new mRNA vaccine formula is an R&D breakthrough, the way forward to actual manufacturer remains littered with questions.

If the recipe can be demonstrated to be biologically equivalent to the Moderna vaccine, then the company might be able to bring it to market by next year, company CEO Professor Petro Terblanche, told Health Policy Watch. But without Moderna’s direct cooperation, the formula could take another three years to get through regulatory hoops, she admitted. 

“Our aim was to replicate the Moderna vaccine and that’s what we hope we have done. If there is equivalence, we might be able to fast-track clinical development. If there are variances then we will have to go for longer-term clinical trials,” Terblanche said.

She predicts that the company will only know which way the vaccine is headed in August, when it has made and tested good manufacturing practice-compliant (GMP) batches.

Vaccine’s development used ‘forward integration’ strategy

While Afrigen is doing the R&D, Biovac would be the first spoke of manufacturing for Africa’s own mRNA vaccines

In June 2021, a South African consortium including Afrigen, Biovac and the South African Medical Research Council (SAMRC) was chosen by the World Health Organization (WHO) to host a new international centre of excellence and training – now known as the mRNA vaccine technology “hub”.  They were tasked with making an mRNA vaccine, then sharing its know-how with companies and countries globally that lack this technology.  A parallel initiative, announced in September 2021, is also ongoing in Brazil’s Oswaldo Cruz Foundation and in Argentina’s Sinergium Biotech.

When the South African hub was first launched, the WHO appealed to pharmaceutical companies to share their know-how.  But Moderna and Pfizer-BioNTech did not respond. So Afrigen’s scientists had to take what was available in open published sources and try to figure it out for themselves (selecting Moderna over Pfizer simply because the company said that it wouldn’t enforce its patent during the pandemic).

“This is not reverse engineering, which implies that we’ve taken the actual vaccine, analysed that and worked backwards to meet the qualities and the composition of what we have analysed,” said Terblanche.

Instead, Afrigen’s scientists used a process of “forward integration”, Terblanche explains. They based their vacccine on the actual sequence for Moderna’s Vaccine 1273, which was discovered by Stanford University and is in the public domain.

From that, “we made the plasmid using our own scientific knowledge base, our own instruments, and our own process mapping;  we made the pDNA, we linearized and purified RNA and we encapsulated it”, she explains.

But while the sequence and the raw materials are the same, the precise vaccine formula still might be different – simply because “we don’t know the ratios because we don’t have the Moderna tech transfer”.

“So we have not pressed the button to make a copy of the Moderna vaccine. We are innovating from a sequence,” Terblanche stresses.

Still hopes that other major pharma firm – may join initiative

Terblanche remains hopeful another experienced pharma firm, will assist with scale-up as “there are always challenges when you scale it up so from the laboratory to big scale, making the vaccines”.

Afrigen needs help with issues such as some of the standard operating procedures, including the formula ratios of the lipid nanoparticles that encapsulate the mRNA; mixing conditions and encapsulating conditions, she says.

“We’ll have to experiment until we get it right or we can get assistance from Moderna or one of the other companies that have got it right to fast-track us,” she says. 

But so far, none of the big pharma firms with approved vaccines have come forward to offer such assistance.

Friede, who has been reaching out to the pharma industry from his seat in Geneva, says that announcement of a pharma partner is pending.

“And at last, I’m pleased to say that a few biotech companies have said we are prepared to share with you some of our knowledge about how to scale up so that you don’t spend too much time,” said Friede.

While Friede said he was as yet unable to name the companies, Moderna and Pfizer are not among them, he confirmed.

“What would have been great is if one of the companies that’s got approved vaccine came along and said ‘we’ll share with you our technology. We’ll share with you our data.’ If that was done, the South Africans would have been able to get a vaccine approved in a space of about 12 to 18 months. Without them, they’re still going to manage to get a vaccine made and approved, but it’s going to take at least three years.”

May be too late for COVID – but not for other diseases

Martin Friede, the WHO official who is coordinating the mRNA hub.

Whatever the timeline may be, the senior WHO official who led the creation of the hub, sees it as a long-term investment to combat future pandemics and diseases endemic to Africa – and accepts that this vaccine candidate might be too late for the COVID-19 pandemic.

“We don’t really know how this pandemic is going to pan out,” acknowledges Friede, himself an ex-pharma officer.  As the leader of an earlier WHO global initiative to develop regional hubs for the manufacture of influenza vaccines, which operated between 2006-2016 – he’s also got extensive experience in what it really takes to build vaccine manufacturing capacity. 

In any case, if the more virulent forms of COVID really fade away over the  few months, becoming another seasonal disease with predominantly mild outcomes in a population that has acquired immunity, then “none of the vaccines that are still in development will be of much use”, Friede told Health Policy Watch.

But if it drags on and countries need to give citizens booster shots, then the South African vaccine could still contribute in a practical way to squelching future rounds of SARS-CoV2, along with building regional capacity in mRNA vaccine manufacturing. 

Primary objective of hub is capacity building for future mRNA vaccines  

Inside Biovac – which is to be the first manufacturing spoke for the mRNA products produced by the South African Hub.

A primary objective of the mRNA hub is not only to build capacity in South Africa, but to train young professionals from other low- and middle-income countries (LMIC) to acquire and use cutting-edge mRNA vaccine technology and production capacity.

This can allow countries in the global South to respond more rapidly and agilely not only to COVID but also future disease threats, for which mRNA vaccines may be highly relevant  – “and there will be future outbreaks”, Friede stresses.

“We need to build a pipeline of other vaccines, for example HIV vaccines, to follow on after COVID to ensure that the facilities that we build are sustainable,” he explained in a recent video.

Ensuring sustainability by diversifying mRNA applications for other diseases

The investment in vaccine research, development and production is massive – the price tag for five years of the hub’s operation is $100-million.

That’s another reason why diversification of mRNA applications to other diseases is critical – ensuring sustainability beyond the current pandemic.

“Sustainability is really around developing a pipeline of vaccine candidates that are not necessarily for COVID, but for diseases of LMICs, particularly in Africa,” says Professor Richard Gordon, Director of International Partnerships at the South African Medical Research Council (SAMRC), another member of the hub consortium.

“The SAMRC’s role is to put together a consortium of researchers to be developing vaccine candidates for life after COVID,” says Gordon.

“We are fundraising, making grants and ensuring a continuum of vaccine candidates for other diseases for when COVID is a thing of the past. We’re going to need to work on HIV vaccines, TB vaccines, HPV, Chikungunya, and Africa Rift Nile fever,” adds Gordon.

But Gordon warns that while many people have romantic ideas about mRNA vaccines, diseases such as TB and HIV still aren’t going to be easy vaccine targets- . In the coming months, the SAMRC will assemble a scientific advisory group to prioritise the diseases most likely to be quelched by mRNA vaccines, he adds.

Staffing requirements another huge challenge

But Gordon admits that the part of the hub that keeps him awake at night is how to ensure that there are enough skilled people to scale up vaccine production – approximately 1000 people are going to be needed to staff the various vaccine initiatives in the country in the next few years.

“There are a number of initiatives on the way around capacity development and the MRC is really trying to be involved in many of them,” he said.  He cited the new WHO Academy, the Pan-African Vaccine Manufacturing group, and a soon-to-be-launched SAMRC scholarship programme being financed by billionaire Patrick Soon-Shiong.

Needs range from PhD graduates to new graduates in life sciences able to move into private tech companies. The new WHO Academy in Berlin is expected to help with training.

Terblanche says Afrigen will be working with the SAMRC to look at other vaccine candidates – adding malaria, Lassa fever, ebola and Schistosomiasis (bilharzia) to the list os possibilities.

“This facility was not designed for COVID-19 only. What we have built is a facility that has the ability to produce vaccines end-to-end from sequence right through to the final fill- finished product and to be multi-purpose and multi-product,” she stresses.

Hub set up in reaction to vaccine hoarding

WHO Chief Scientist Soumya Swaminathan

Said WHO Chief Scientist Dr Soumya Swaminathan, WHO decided to set up an mRNA hub in the face of vaccine hoarding by wealthy countries as well as export bans.

India’s decision to ban exports of its locally-produced version of the Astra Zeneca vaccine, Covishield, during the spring 2021 Delta wave was devastating for the global COVAX vaccine facility – which abruptly lost its main supplier, the Serum Institute of India, that was contracted to supply hundreds of millions of vaccine doses destined to Africa and other low-income countries.    

“It became very obvious that the countries that were suffering the most were those that were dependent entirely on imports,” says Swaminathan, adding that the WHO decided to establish a “multilateral mechanism for technology transfer”.

“The concept here is that it is a global hub that shares technology with anybody who wants  to receive it, focusing on LMIC countries and those which do not have adequate capacity,” says Swaminathan, adding that mRNA was chosen because it “has immense potential” for other diseases not just COVID-19.

The Medicines Patent Pool (MPP) is supporting the hub with licensing and fundraising, says executive director Charles Gore. France has already made a substantial donation to the hub.

“We had hoped that some of the originators of the current vaccines would come to us and agree to licence their technology to us that’s not happened,” said Gore, echoing the disappointment of Terblanche and Friede.

“But there may be licencing around second-generation technologies that we would like to incorporate,” adds Gore, who stresses that the mRNA hubs intend to strictly abide by existing patent rules.

Eventually, the WHO intends to have at least one mRNA vaccine training and production hub in each of its six regions. Along with the identified sites in Argentina and Brazil for the Americas,  other regions are expected to make announcements soon.

-Elaine Ruth Fletcher contributed to this story

Image Credits: Afrigen .