European Medicines Agency schedules potential vaccine recommendation for 21 December
The European Medicines Agency has brought forward the date on which it could recommend approving EU use of the Covid-19 vaccine developed by BioNTech and Pfizer, by scheduling a meeting of its relevant committee for 21 December.
Announcing the news on 15 December, the EMA said the committee would reach a conclusion at the newly scheduled meeting “if possible”. It said a meeting previously planned for 29 December would go ahead “if needed”, pending evaluation of additional data on the vaccine provided by its developers.
With countries including the UK, Canada and the United States already having approved emergency use of the vaccine, the EU and its member states have been facing questions over their decision to unite in giving the EMA more time to consider a recommendation for a longer-term approval.
The EMA said its human medicines committee “will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks”.
Once the committee has made a recommendation, the European Commission will then “fast-track its decision-making process with a view to granting a marketing authorisation valid in all EU and European Economic Area member states within days”, the EMA said.