As European Medicines Agency Approves One-Shot Johnson & Johnson COVID Vaccine – US Has Surplus & Africa A Dearth of Doses Analysis 11/03/2021 • Elaine Ruth Fletcher & Raisa Santos 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) The Johnson & Johnson COVID-19 vaccine. With the European Union Medicines Agency (EMA) approval Thursday of Johnson and Johnson’s one-shot COVID-19 vaccine, it now remains to be seen which countries and regions will be the first in line for distribution of the one-jab vaccine. Along with its comparatively low-cost, and ease of storage, the one-shot vaccine could be particularly important to Africa in light of its demonstrated its efficacy against the wily virus variant B.1351, first identified in South Africa. “With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”. The challenge now, for the pharma company is how to share the bounty. Johnson and Johnson had last year reached an agreement in principle with Gavi, The Vaccine Alliance, to supply the new COVAX vaccine facility with up to 500 million doses through 2022 – which would go to low- and middle-income countries. It also has pledged to charge a ‘non-profit’ US$ 10 price during the pandemic, making it particularly attractive to lower-income countries. But it also now has major supply commitments to Europe, the United Kingdom and the United States. Following the EMA approval, the WHO can be expected to rapidly issue its own “emergency use listing”, clearing the way for the vaccine’s rollout by COVAX. Known Vaccine Manufacturing Capacity – J&J However, the United States this week doubled its own order of the J&J vaccine to 200 million doses. The European Union has also ordered 200 million doses of the shot, with an option for 200 million more. The UK has options for 55 million doses. And, meanwhile, the J&J agreement with COVAX would only supply 100 million doses to the global facility this year. The bigger dilemma is that the COVAX rollout is right now almost exclusively dependent on the Astra Zeneca vaccine. And that vaccine yielded poor results in a South African trial of healthy adults, where it failed to demonstrate efficacy in preventing mild and moderate forms of COVID disease. That left South Africa to rapidly pivot to the Johnson & Joshnson vaccine several weeks ago, for the first stage of its vaccine rollout to health workers. Insofar as South Africa was participating with J&J in clinical trials, it had access to at least some initial vaccine supplies. But other African countries don’t have that luxury. So in more ways than one, the J&J vaccine’s distribution is likely to be watched as a bellweather of equity – or not. Advocacy Groups Call For More J&J Vaccines to be Shifted to Low-Middle Income Countries COVID -19 Secured Doses 2021, aggregate and per capita, by countries’ income level Advocacy groups have recently issued calls for the first cuts of the J&J vaccine to go to low- and middle-income countries through COVAX. They point out that even South Africa, whose Aspen Pharmacare is set to produce some 300 million doses of the vaccine, will only keep a fraction ( 9 million doses) for itself. Meanwhile, the country is on the front lines of the battle with the B.1351 variant, which is slowly creeping northward across eastern Africa – as well well as appearing in Ghana on the west African coast. All of those countries remain almost exclusively dependent on the COVAX supply of AstraZeneca vaccines – complemented by some donations from China, whose vaccines have never undergone a regulatory review. “MSF is worried that if J&J continues with business-as-usual tactics, countries most affected by this variant will once again be left waiting at the back of the queue,” stated an appeal two weeks ago, issued just ahead of the very first, US Food and Drug Administration, approval. “For example, South Africa has the highest prevalence of this variant in the world and has been a critical partner in J&J’s clinical trials, yet the country is due to receive a mere nine million of the 300 million doses that will be filled in vials and packaged by a local manufacturer. J&J should right away ensure that South Africa receives, at minimum, enough doses to vaccinate its healthcare workers and high-risk groups, as well as prioritize shipments to other low- and middle-income countries. While WHO has sought to reassure African nations the the AstraZeneca vaccine can still be effective against serious disease from the variant – that hasn’t yet been demonstrated in a clinical trial – in the same way that the J&J vaccine has been tested. And as MSF stated, the vaccine’s one-jab regimen and modest refrigerator storage requirements make it particularly attractive in lower-income settings: “The vaccine could be an important tool in the world’s response to this pandemic – particularly in low-resource settings where MSF works – since unlike the other COVID-19 vaccines being used today… it could require only one dose and could be stored at normal refrigerator temperatures.” US and Other Rich Countries Keep Piling Up Vaccine Surpluses On the other side of the Atlantic, meanwhile, noting that some 850 million vaccine doses have been purchased by the United States for an adult population of only 260 million – enough to vaccine all eligible adults three times over. “Prospects of a vaccine shortage giving way to a surplus seem nearer than ever this week,” noted the Washington Post, wryly. However, with the largest J&J manufacturing base in the United States, the US also can impose export barriers on the vaccine – should it choose to do so. And even without an outright export ban, nearly 1.5 billion doses of J&J’s vaccine are already tied up in advance purchase agreements, most (801 million out of 1.439 billion doses) committed to high-income countries. Dr Paul Stoffels, vice chairman and chief scientific officer at Johnson & Johnson.Pharma sources say that J&J’s Vice Chairman and Chief Scientific Officer Paul Stoffels, the Belgian-born physician who has spearheaded the vaccine’s R&D through its European affiliate, Janssen, is deeply committed to a rapid rollout of the new product in low- and middle-income countries – and possesses a track record on equity issues, with J&J’s prior development of an Ebola vaccine, as just one example. At the same time, J&J has also received US $1.5 billion from the US government for its COVID-19 vaccine R&D, and the United Kingdom is co-funding a global clinical trial testing a two-dose regimen of the vaccine. In light of those hefty research investments, the pre-purchase agreements, and the J&J manufacturing hubs clustered in the United States and Europe, it remains to be seen if the US, the EU or other high income countries that have snapped up more vaccines than there are people to jab, might offer to release some of those excess supplies to COVAX, the African Union or even directly in bilateral deals. If those countries act, it might enable a more rapid rollout of the single-jab vaccine in parts of the world that not only need it the most – but where the vaccine could also have the most impact in halting the global spread of dangerous variants. Image Credits: Johnson & Johnson, Johnson & Johnson, IFPMA, IFPMA , World Economic Forum. 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