Chief nurse nurse Sam Foster holds a vial of the Oxford University/AstraZeneca COVID-19 vaccine at the Churchill Hospital in Oxford, southwest England on January 4, 2021.
Steve Parsons | AFP | Getty Images
LONDON — The coronavirus vaccine developed by AstraZeneca and the University of Oxford has been approved by Europe’s drug regulator, the European Medicines Agency.
The EMA said on Friday it had assessed the safety and effectiveness of the Covid vaccine and recommended by consensus a formal conditional marketing authorization be granted by the European Commission, the EU’s executive arm.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” Emer Cooke, executive director of EMA, said in a statement on Friday.
“As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens,” Cooke said, referring to the EMA’s human medicines committee.
The vaccine is already in use in the U.K., having been approved at the end of December, and now makes up the bulk of jabs being administered in the country, along with the Pfizer–BioNTech shot, which has already been authorized for use in the EU.
The approval comes at a tricky time for the EU, with its vaccination program sluggish at best, and looking very vulnerable to supply shortages.
It was dealt two blows in the last few weeks, firstly from Pfizer, which said it would be temporarily lowering production while it upgraded its production capacity at its Belgian plant. Then last Friday it was reported that AstraZeneca would be delivering far fewer doses to the bloc in spring than initially expected, due to production issues at its plants in the Netherlands and Belgium.
The delays have prompted a crisis in the EU, which has said it could curtail the exports of coronavirus vaccines from the bloc in a bid to prioritize its citizens.
On Wednesday, the EU demanded that AstraZeneca fulfil its agreement to supply it with millions of coronavirus vaccines by whatever means necessary, suggesting that the company divert some supplies from its U.K. production facilities to the EU.
Then on Thursday, doubt was poured on the possible authorization of AstraZeneca’s vaccine after Germany’s vaccine committee said it was recommending that the vaccine should only be offered to people aged between 18-64.
This, it said, was because there was not enough data to assess the efficacy in people aged over 65.
Elderly trial participants were admitted later to phase three clinical trials of the AstraZeneca shot, which took place in the U.K. and Brazil, and earlier on in South Africa, and so there is less available data on its efficacy in the over-65s.
AstraZeneca said this data would accrue when it published its trial findings in the medical journal The Lancet in December: “As older age groups were recruited later than younger age groups, there has been less time for cases to accrue and as a result, efficacy data in these cohorts are currently limited by the small number of cases, but additional data will be available in future analyses,” it said.
On Friday, when the AstraZeneca approval was announced, the EMA said there were not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group. However, it said that “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.”