The European Medicines Agency (EMA) has convened a “exceptional reunion” of its Committee for Human Medicines (CHMP, for its acronym in English) on December 21 to “conclude if possible” its evaluation of the vaccine from Pfizer and BioNTech.
Until now, the CHMP was scheduled to meet to make a decision on the vaccine on December 29. This meeting, in any case, “will be maintained if necessary”, points out the EMA, which thus opens the door for the evaluation not to be closed on December 21.
“Following the receipt yesterday afternoon of the additional data requested by the CHMP from the company and awaiting the outcome of its assessment, a one-off CHMP meeting has been scheduled for 21 December to conclude if possible. The meeting scheduled for December 29 will be held if necessary “, details the European regulatory agency in a statement.
The EMA’s decision to advance the meeting came after this Wednesday the German newspaper ‘Bild’ advanced that the EMA could recommend the approval of this vaccine on December 23, as the German Health Minister, Jens Spahn, has also claimed at a press conference.
In its statement, the EMA explained that the Committee for Medicinal Products for Human Use will conclude its evaluation “as soon as possible and only when the data on the quality, safety and efficacy of the vaccine are sufficiently robust and complete to determine whether the benefits of the vaccine outweigh its risks. “
“The rate of progress depends on a solid and comprehensive assessment of quality, safety and efficacy, and it is determined by the availability of additional information from the company to answer the questions raised during the evaluation, “the agency justified about this advancement of the meeting.
Once the CHMP recommends its marketing authorization, the European Commission assures that it will “accelerate its decision-making process to grant an authorization of marketing valid in all EU Member States within a few days“.