EMA considers authorising AstraZeneca vaccine only for those under 65 due to lack of data

European Medicines Agency chief asks for more information on effectiveness in new variants

2 min
The Executive Director of the European Medicines Agency, Emer Cooke

BrusselsThe vaccination campaign has come against many obstacles around the world. Beyond the delays in deliveries by Pfizer and also those announced by AstraZeneca, the new variants of the coronavirus have called into question the effectiveness of the doses that have already begun to be distributed - or are about to. And in the case of the Oxford/AstraZeneca dose, there are even more uncertainties because, according to the European Medicines Agency (EMA), there is insufficient data on its efficacy in people over 65 years of age. Therefore, one possibility could be to authorise it partially, only for a certain age group. The EMA is due to take a decision next Friday.

"Without anticipating what the experts may decide, an authorisation only for a particular age group is possible", EMA director Emer Cooke said at a hearing in the European Parliament on Tuesday. EMA experts meet on Friday to authorize the Oxford vaccine (or not), surrounded by controversy in Europe by the announced delay in the delivery of doses agreed on with the EU. Cooke has shared the concerns of several MEPs about these delays and said he was working to find ways to increase production capacity.

Doubts about effectiveness of new variants

The other major question on the table for the European authority is the efficacy of vaccines on the new variants of the coronavirus, which have been shown to be more contagious. "We still need more information on the effectiveness of the new variants", Cooke said, specifying that they have already asked Pfizer and Moderna for this data. Depending on the responses, the EMA will have to decide whether the dosage formulation needs to be changed and whether a new marketing authorisation will be required. For example, Moderna is already studying a variant of its vaccine to respond to the South African coronavirus variant.

The EMA is also under scrutiny in a context where the overall efficacy of vaccines and its independence as a European agency free from political control are being questioned. In response, it has announced that it will launch independent studies to assess the safety of vaccines. The first, on the Pfizer vaccine, will be published "this week", Cooke said.

Beyond these two hot debates, the director of the EMA explained that in addition to the vaccines, they were analyzing and were waiting to authorize up to fifteen drugs to treat the symptoms of the coronavirus to help people who are already infected. According to Cooke, these drugs are expected to be approved this year.