The European Union could authorise the marketing of the first Covid-19 vaccines in the coming weeks. The European Medicines Agency (EMA) is currently analysing applications for conditional marketing authorisations submitted by Pfizer-BioNTech and Moderna. It could take a decision “at the latest” on 29 December for the former, and 12 January for the latter.
The EU Agency confirmed on Tuesday 1 December that it has so far received two applications for conditional authorisation for Covid-19 vaccine candidates, one submitted by the Spanish subsidiary of Moderna for its mRNA1273 candidate and the other by the Pfizer - BioNTech consortium for the BNT162b2 candidate. Already engaged in a rolling review process, the EMA says it will conduct its evaluation on an accelerated schedule, which is expected to take only a few weeks if the data submitted is sufficiently robust and complete to demonstrate the quality, safety and efficacy of the vaccine.
The EMA will then submit its opinion to the European Commission to enable the latter to take a final decision. “This is obviously a decision that needs to be taken urgently”, said European Commission spokesman Stefan De Keersmaecker. “If the EMA gives a positive recommendation, the Commission will do its utmost to reach a rapid authorisation decision, after consulting the Member States”, he continued, referring to a matter of “days”.
The Commission decision is taken by the ‘committee’ procedure, which requires the approval by qualified majority of the Member States meeting in a dedicated committee.
MEP Peter Liese (EPP, Germany) welcomed the schedule. In his view, the control procedure chosen by the EU is likely to be longer than the urgency procedure applied by the United States or the United Kingdom. “Trust is good, checking is better”, he stressed. (Original version in French by Sophie Petitjean)