The European Medicines Agency (EMA) is currently assessing an application for Conditional Marketing Authorisation (CMA) for the Pfizer/BioNTech candidate, BNT162b2. A meeting of the EMA’s human medicines committee (CHMP) has been brought forward by a week to Monday (December 21); and a favorable opinion could see the vaccine authorized a few days later.
The technology from Germany’s BioNTech, developed with US partner Pfizer, would become the first COVID-19 vaccine available in Europe.
The companies started a rolling review for mRNA vaccine BNT162b2 with the EMA in October, allowing the regulator to start assessing available data from pre-clinical studies. It submitted its conditional marketing authorisation application on December 1.
If the EMA recommends authorization of the vaccine, the European Commission will fast-track its decision making process. Although the EC has not specified a date for its decision, it has already announced vaccinations will start on December 27.
Pfizer and BioNTech have agreed to supply up to 300 million doses to the EU, although it is not yet clear how many of these will be available on December 27. The EU has five other vaccine supply deals in place: with Sanofi/GSK, AstraZeneca, Moderna, Curevac and Janssen.
It announced today that it is close to adding a seventh deal: exploratory talks with Novavax have been completed for the initial supply of 100 million doses, which could be extended by another 100 million doses.
Once authorized, vaccine doses will be distributed to Member States on a pro-rata basis according to the number of cases. National authorities are in charge of creating their own vaccination policies.
The EMA is currently evaluating four COVID-19 vaccines: Pfizer/BioNTech and Moderna (both of which have submitted an application for conditional marketing authorisation); and Janssen and AstraZeneca’s candidates (which are under rolling reviews). Moderna's CHMP meeting is scheduled for January 12.
COVID-19 vaccine is on its way. Meanwhile, we support EU countries in preparing their vaccination plans, such as:— European Commission (@EU_Commission) December 16, 2020
Identifying priority groups
Preparing the infrastructure and logistics
Training health workers
and more! #SafeVaccines#VaccinesWorkpic.twitter.com/NU9KolHwOt
The UK authorized the Pfizer/BioNTech vaccine earlier this month and has started vaccinations: with the MHRA in charge of drug regulations in the country.