EMA to Wrap up Pfizer-BioNTech Review on Dec. 21
Facing scrutiny from the manufacturers, health ministers of some member states and the public, the European Medicines Agency (EMA) has moved the timetable to conclude data analysis of the Pfizer-BioNTech Covid-19 vaccine candidate BNT162b2 forward by a week.
The EU drugs regulator announced on Dec. 15 that it now plans a special meeting for Dec. 21 to wrap up deliberations, but will maintain the originally planned Dec. 19 date in case more time is needed.
Emergency authorization of the first Covid-19 vaccine candidate to cross the finish line has already taken place in six countries, including the UK, US, Canada, Bahrain, Saudi Arabia and Mexico. In some of the countries, vaccinations are already in progress.
Usually first to authorize a new medicines entity, the US made headlines by becoming only the fifth to greenlight emergency use, on Dec. 11. The EU also has been seen as moving comparatively slowly toward a Conditional Marketing Authorization (CMA), as the permit is known in the bloc’s terminology.
In a statement, the EMA said its human medicines committee (CHMP) and outside experts “have been working intensively over the past weeks” to evaluate data submitted by BioNTech and Pfizer in their application for a Europe-wide CMA.
Defending its pace, the regulator stressed that the route to a decision “is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.”
In this context, the EMA said it had only just received the additional data requested by the CHMP from the vaccine makers and will conclude its assessment “at the earliest possible time.” It stressed, however, that in addition to being robust, the data must be complete in order to determine whether the vaccine’s benefits outweigh its risks.
Once the CHMP recommends a marketing authorization, the agency said the European Commission will then “fast-track its decision-making process with a view to granting a marketing authorization valid in all EU and EEA member states within days.”
Europe’s CMA for the first Covid-19 vaccine will come with “safeguards, controls and obligations.” These, the EMA said, would include full prescribing information and package leaflet with detailed instructions for safe use; a robust risk-management and safety monitoring plan; manufacturing controls including batch controls for vaccines and conditions for storage; an investigation plan for use in children; legally binding post-approval obligations and a clear legal framework for evaluation of emerging efficacy and safety data.
A marketing authorization ensures that all Covid-19 vaccines “meet the same high EU standards as for all vaccines and medicines,” the EMA said. With this in hand, the roll-out can be started in all member states at the same time.
Author: Dede Williams, Freelance Journalist
