The future of AstraZeneca's vaccine rollout hinges on 2 crucial decisions, after a month of suspensions and dose shortages
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- The EMA will conclude Thursday whether or not AstraZeneca's COVID-19 vaccine caused blood clots.
- If the vaccine is indeed safe, as expected, it would mean up to 18 countries can give it out again.
- Separately, the US awaits results of a trial that could determine FDA authorization of AstraZeneca's shot.
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Oxford University and drug giant AstraZeneca have found themselves at the heart of European political theatre over the past few weeks. The groups' COVID-19 vaccine has been suspended in more than a dozen European countries after a small number of blood clots, including with "unusual features" such as low platelets, were reported in a few people immunized with AstraZeneca's shot.
Vaccine regulators and the World Health Organization (WHO) have said the vaccine is safe - but after Denmark suspended the shot on March 11, country after country followed, saying they would wait on the results of an investigation from the European Medicines Agency (EMA), which is expected to conclude later on Thursday.
The stakes for the EMA's investigation are high: A finding that the vaccine is indeed safe, as experts expect, would free up the 18 countries that have suspended the shot to begin delivering them again. But if the saga stretches on, it could potentially jeopardize the vaccine rollout in Europe and beyond.
The latest furore comes on top of a backdrop of EU vaccine shortages and mixed messages from EU political leaders on the AstraZeneca shot since the start of the year.
AstraZeneca cut its vaccine supply to Europe by 60% from 80 million to 31 million doses in January, citing production issues. Italy and France have since individually threatened to sue AstraZeneca for a breach of contract, and Europe now insists on authorizing any exports of home-made vaccines - including AstraZeneca's, which is made at various sites in Europe - to outside of the EU.
At the same time, AstraZeneca's vaccine is the least-favored shot in Europe, partly thanks to confusing rulings about the effectiveness of the shot, especially in older people.
In Germany, for example, there were erroneous German media reports in late January that the shot was only 8% effective. The country then did not authorize the shot for those older than 65, citing insufficient evidence in this age group, despite the EMA's ruling that the vaccine was safe and effective in all age groups. German Chancellor Angela Merkel said at the time that she wouldn't get AstraZeneca's vaccine because she was 66 - Germany has since back-tracked.
Countless countries suspending the vaccine are unlikely to help public confidence.
EMA investigation could unlock AstraZeneca vaccine in 18 countries
If the EMA finds the vaccine does not cause blood clots, the 18 countries that have paused the shot are expected to immediately lift their suspensions, therefore avoiding any significant delay to their vaccination programs. French Prime Minister French PM Jean Castex said Tuesday that he would "very quickly" get a shot of the AstraZeneca vaccine if France lifts its suspension, in a bid to reassure the French population that it was safe.
Countries beyond Europe, such as Indonesia and the Democratic Republic of Congo, have also paused the shot after the reports from Europe. The EMA's investigation could put an end to those suspensions, too.
AstraZeneca's vaccine protects against COVID-19, doesn't require ultra-cold storage temperatures, and is fairly cheap - this makes it a useful tool in tackling the pandemic, especially in low- and middle-income countries. AstraZeneca said in November it was making manufacturing capacity for up to 3 billion doses of the vaccine in 2021, on a rolling basis.
But a different ruling, or any further delays after the EMA investigation, could mean fewer people get vaccinated - in Europe and beyond. The European Commission has already said the suspension could "possibly" impact the EU target of vaccinating 70% of the adult population by September 21, per The Telegraph.
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The EMA's investigation also comes as the US awaits much-anticipated results from AstraZeneca's clinical trial involving more than 30,000 people, which are expected within weeks. The trial results will be fundamental to the Food and Drug Administration's decision as to whether AstraZeneca's shot can be rolled out in the US, as it has been elsewhere in the world.
The US results are also expected to clear up any confusion around the vaccine's efficacy, because its design was less complicated than previous trials of the shot that combined multiple studies with variable methodologies. In the US trial, participants also all got two full doses of the vaccine - during trials in the UK, some participants were given half doses, allegedly by mistake, which initially seemed to impact how well the shot worked.
Emer Cooke, the EMA's executive director, said Tuesday that the agency was "firmly convinced" the benefits of the shot outweigh any risks, while noting it was the prerogative of each country to suspend the shot if they wanted.
The EMA would be guided by "science and independence" in its investigation, she said. The results are expected Thursday afternoon - the world awaits its recommendation.
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