WHO Projection of 3 Billion Dose Vaccine Shortfall In COVID Booster Scenario – ‘Not Based on Valid Data’ Says Pharma Health Equity 16/12/2021 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Associations A recent WHO estimate that there could be a 3 billion shortfall in COVID vaccine doses needed to vaccinate the world in the first quarter of 2022 – if high-income countries “aggressively” booster adults with third shots as well as immunizing children is not based on “valid, solid” data, charged pharma leader, Thomas Cueni on Thursday. The WHO statements were reported in a Financial Times interview with Tania Cernuschi, WHO technical lead for global vaccine strategy. She was quoted Wednesday as saying: “There is a scenario where very aggressive consumption of doses by high- coverage countries to conduct paediatric vaccination and provide booster doses to all citizens . . . could lead to a constrained supply situation for the first half of 2022. “The gap in the first quarter of 2022 could be of about 3 billion.” Financial Times mapping of WHO claims of 3 billion vaccine dose shortfall – pharma leaders challenge shortage claims – saying boosters won’t drain global supplies. Seth Berkley, CEO of Gavi, the Vaccine Alliance, the leading WHO partner in the COVAX global vaccine facility recently expressed similar sentiments in an AP interview – saying that widespread reliance on booster doses in rich countries could also lead to more vaccine hoarding and “Inequity 2.O” in 2022. Speaking at a press conference on Thursday, Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), challenged the statements saying that supply-side dynamics were no longer the biggest problem in the world’s largest-ever vaccine rollout. Rather, challenges in actually distributing and administer vaccines, as well as combatting vaccine hesitancy, loom as larger issues now, he asserted: ”To be honest, I have no clue how anybody could come up with this [3 billion] number because when I look at current vaccination rates on a global scale, even anticipating that you could have a monthly five to 10% increase, we still have about 1.3 billion excess doses in the rich countries by the end of March 2022, which are there to be used for dose-sharing, and which are there to get into the arms of people. “Therefore this 3 billion sounds scary. But I simply don’t believe that it’s based on valid, solid data. … I will ask who actually came up with the number and how did they come up with the number?” Asked by Health Policy Watch for a comment on the potential 3 billion vaccine shortfall, WHO did not immediately reply. Moving from supply side to demand side constraints Upper right clockwise: Michelle McMurry-Heath, BIO; Sy Prasad, Bharat Biotech at IFPMA press briefing Cueni maintained that the biggest challenges in achieving global vaccination goals now lie on the demand side. “We have now moved from supply constraints to absorption constraints,” he said, speaking at a press briefing organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Topping the list of the barriers are vaccine hesitancy and the ability of many poor countries with weak health systems to absorb vaccine doses rapidly, he contended. “Countries have said, ‘please slow down the distribution rates. I’ve been contacted by vaccine manufacturers who are saying ‘I have dozens of millions in a warehouse, can we speed up the procedures for the purchase orders?’ “Realizing we moved from supply constraints to absorption complaints, moving from vaccines to vaccinations, you need to mobilize the health workers, you need the cold chains, you need [to extend] the shelf life. “We really need a surge effort, we need to address infrastructure for absorption,” he said stressing that this “requires investment in funding in country readiness; you need to have the cold chains, the infrastructure to make sure that the vaccines get from the tarmac into the arms of people. “And we also need to take on vaccine hesitancy,” he added, saying, “I’m Swiss, and I am embarrassed by the low rate of vaccination rate in my country; we have plenty of vaccines but we can’t seem to get beyond the 70%”. In fact, only about 65% of Switzerland’s eligible population is fully vaccinated. For the European Union the figure stands at 67%. Only 7% of Africans have been vaccinated so far – while only three of the continent’s 55 countries – Egypt, Morocco and Zimbabwe – are on track to meet the WHO target of vaccinating 40% of people by the end of this year. Globally, some 98 mostly low- and middle-income countries will miss the 40% target. Administering boosters, where available, will be ‘more protective of everyone’ Michelle McMurry-Heath, CEO Bio Even so, Michelle McMurry-Heath, President & CEO of the US-based, Biotechnology Innovation Organization (BIO), argued at the briefing that that boosters administered in rich countries would help protect everyone – without impinging on the pace of rollouts in poor countries – which are increasingly hampered by logistics, health worker, and cold chain constraints. “We are on track to deliver vaccines to absolutely every person who is eligible by March of next year,” she declared, referring to a WHO global goal of vaccinating 70% of the world’s population by then. But along with infrastructure and logistics issues in poor countries, vaccine hesitancy in rich and poor countries alike, is sure to play a role in the end runs of any global vaccination campaign, she stressed. And that is why boosters may be all the more important, she argued. Current vaccines’ effectiveness against the Omicron variant “We’ve seen a reluctance in the US and in Europe to really promote a third dose out of concern for optics. Well you don’t want to do that. We want to make sure that we have enough supply for everyone, but at this point, we need to take the vaccine-accepting population as it exists and make sure that they are protected as well as the science tells us that they can be, so that they can help stop the spread of new variants. So we can purpose both simultaneously. We can get vaccine doses out to everyone around the world. But we also need to take advantage of the ground work that was laid with people who have already accepted the vaccine to make sure that they stay protected and make sure that they become the backstop to preventing further spread of the virus and further development of variants. That will be more protective for everyone, no matter where you live.” Rollout of new omicron-specific vaccines would create bigger supply shortage risks than boosters – Airfinity 2022 production scenarios – with and without a new ‘Omicron-specific’ jab. Not boosters, but rather the development of new omicron specific vaccines would pose the biggest risk to production volumes and continuity of global supplies, said Rasmus Bech Hansen, CEO & Founder of the data forecasting firm, Airfinity, who presented the company’s latest data at the briefing. Hansen predicted that total global production of COVID vaccines would top 19 billion doses by June 2022 – leaving plenty of space for both expanding vaccine campaigns in low-income countries – while also rolling out booster doses. However, that production pace would slow significantly if manufacturing firms had to reboot their production lines to deal with an entirely new kind of COVID vaccine dose, he warned. “There will be bigger supply constraints if we shift to creating omicron specific vaccines than if we continue to give out boosters,” said Hansen. Cueni, however, added that he was hopeful an Omicron-specific vaccine might not be needed – in view of the emerging data that people who got boosters of the original vaccine prototypes are retaining robust resistance to serious disease. “Evenif you did do this booster for the entire adult population, you would still see some 1 billion vaccine surplus. If you do need a new vaccine for omicron, that would lead to some disruption and interruption, but on the other hand you have new vaccines coming only. We need to keep our fingers crossed….” COVAX will nearly reach its 2021 vaccine distribution target for poor countries – but still ‘dismally disappointing’ COVAX supply forecasts – from a vaccine facility for the world, it has become a vaccine supplier to the world’s 93 lowest-income countries, including most of Africa. Meanwhile, the global COVAX facility that had initially set a target of reaching 20% of people in poor countries with vaccine doses – will nearly reach that goal, said Cueni, noting that some 700-800 million doses out of the planned 950 million doses will reach the 93 low-income countries that receive donations from the global facility by end 2021. The remaining 1.1-1.2 billion doses that COVAX had planned to distribute were in fact destined initially for high – and middle-income countries – which eventually backed out of the initaitive and bought their own vaccines in bilateral deals, he pointed out. But he admitted that in term of the equity dynamics, the effort to mount a unified global vaccine distribution effort had been “dismally disappointing.” “Rich countries moved from hedging, they didn’t know which vaccines would make it [to regulatory authorization], to hoarding, of up to 10 jabs per person in some countries. Sadly it was not until September when dose-sharing [ from rich to poorer countries] really started,” he observed. The COVAX facility had also been plagued by a lack of funds to compete with high-income countries for the purchase of pharma doses at the outset of the pandemic, said Cueni, saying that a standing fund of resources would be needed to make a mechanism like COVAX more viable in the future. “COVAX was late in the game. They didn’t have the money, they were not allowed to sign the checks for the big [vaccine] purchases at a time when the US and Canada and many others were doing exactly that. “One really needs to make sure that for a future pandemic you have, arms length, you really do have a pot, at arms length, where COVAX -Mark II, is equipped. “We also need to have a kind of social contract which is based on making sure that vaccines go to those most in need, based on public health assessment, like front-line health care workers and vulnerable populations. “Healthcare workers, that’s about 1% of the global population, and the elderly, that’s about 10% of the global population. That is something doable, but we need to make sure that we are talking now about how we can avoid the problems we ran into now, because I think that everyone is ashamed and embarrassed by the inequitable access we see right now.” Developing country vaccine manufacturers – new partnerships in Africa There are over 150 promising vaccine candidates in the clinical trials pipeline, including over 50 candidates in Phase 3 and 4 trials Meanwhile, there are already some 300 vaccine manufacturing partnerships ongoing globally – and new undertakings are now emerging in Africa as well, the pharma panelists said. Those include new deals by Moderna in Rwanda and negotations by the Indian firm, Bharat Biotech with potential African manufacturing partners and investors, said Sai Prasad a executive at Bharat Biotech, which developed the first Indian-made COVID vaccine, Covaxin. “Bharat Biotech is shortlisting countries in Africa for a potential manufacturing facility,” he said. In addition, the South African firm Biovac, which is partnering with Pfizer, is eventually set to move from only “fill- and-finish” of the Pfizer/BioNTech vaccine to engagement in the entire vaccine manufacturing process, he said. Finally, there are high hopes for a new WHO-established mRNA manufacturing hub, also in South Africa, will develop and produce new generation vaccines that can be more fit-for-purpose in developing countries, said Prasad, who is also president of the Developing Countries Vaccine Manufacturing Network. As still newer, and even more innovative vaccines now in the pipeline, come online, including innovations in developing countries, he maintained. “There is already a company in India called Genova – they are working on an mRNA vaccine. They’re doing Phase 2 clinical trials right now. There are companies manufacturing and developing vector-based vaccines. A company called Zydus Cadila has developed a DNA vaccine which is given through the skin, with a painless delivery device. “We are developing an intranasal vaccine that could be given as drops into a nostril, which is much easier. So I think there is a lot of innovation that is going on in the developing countries also and you will see this in the second wave of vaccines to come. While proponents of an World Trade Organization intellectual property waiver have said that waiving IP rights would jumpstart far more engagement by developing country innovators and manufacturers, Prasad and McMurry-Heath disagreed that IP was the major barrier to tech transfer. Merely having access to the IP also is not a guarantee of access to the know-how that is really needed to manufacture sensitive vaccines, and therefore encouraging more voluntary partnerships will ultimately build capacity more reliably, said Prasad: “Technology transfer is not as easy as it seems.. This concept of intellectual property rights, everybody tries to simplify it a lot.. But it has to be followed through with voluntary technology transfer.” McMurry-Heath pointed to the partnerships that are already ongoing saying: “I think we have to pay attention to what’s underway and what’s being built. Before we kind of blindly say that it can be done in so many more countries. It’s been very, very difficult to bring those 300 [vaccine manufacturers] online, where you have very, very close relationships and partnerships between the innovators and the manufacturers.” Added Cueni, “vaccine manufacturing, whether it’s classical vaccines or mRNA, is anything but easy. Therefore not everybody who claims to be the master chef will be able to fill my expectation when it comes to having a decent dinner. And therefore I would treat these kinds of claims with a grain of salt.” Image Credits: The Financial Times , Airfinity. 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