The European Medicines Agency (EMA), will meet on Monday, December 21, speeding up the process of approving the Pfizer vaccine, in order to give the “green light” to the vaccinations.
The approval decision will be taken eight days earlier than planned by the Amsterdam-based Agency.
The European Medicines Agency says in a statement that experts have been working hard in recent weeks to evaluate the data submitted by BioNTech and Pfizer in the context of the conditional marketing authorization application for the coronavirus vaccine.
The pace of progress depends on reliable and complete evaluation of quality, safety and effectiveness and is determined by the availability of additional information from companies that will answer questions asked during the evaluation.
“After receiving the additional data requested by the CHMP from the company yesterday afternoon and pending the outcome of the evaluation, an extraordinary meeting of the committee was scheduled for December 21”, the agency said, adding that the meeting scheduled for 29 December will be maintained if needed.