Pfizer vaccine, Ema opinion on December 21

Published on: 12/15/2020 12:02 PM

Ema’s opinion on the Pfizer-BionNTech coronavirus vaccine could come earlier than expected on December 21. “After receiving last night the additional data requested by the company’s CHMP (the Committee for Medicinal Products for Human Use of the EMA, ed) of the company, and pending the result of its evaluation, an exceptional meeting of the CHMP was” in fact “scheduled by December 21 to conclude if possible “on the approval of the product-shield, announces the regulatory body of the EU. “The meeting scheduled for December 29 will be held if necessary.”

The CHMP and its experts, explains the EMA, have worked intensively in recent weeks to evaluate the data submitted by BioNTech and Pfizer in the application for a conditional marketing authorization (Cma) for their mRna vaccine. “The speed of progress” of the dossier, specifies the Agency, “depends on a solid and complete evaluation of the quality, safety and efficacy” of the product “, and is determined by the availability of additional information by the company to respond to the questions posed during the exam “. Therefore, having received the requested data, the EMA has convened a one-off CHMP meeting for 21 December, ahead of the 29 initially announced.

“The CHMP will conclude its evaluation as soon as possible – reads the note from the European regulatory body – and only once the data on the quality, safety and efficacy of the vaccine are sufficiently robust and complete to determine whether the benefits of the product exceed its risks “. After the CHMP has recommended the green light for the vaccine, “the European Commission will accelerate the decision-making process to grant a valid marketing authorization in all EU member states and the European Economic Area (EEA) by Few days”. “The EMA, its experts and the European Commission – insists the Agency – are working on the first marketing authorization of an anti-Covid vaccine with all the safeguards, controls and obligations imposed by a Cma, including that: complete prescribing information and package insert with detailed instructions for safe use; robust safety control and risk management plan; manufacturing controls, including batch checks and storage conditions; research plan for use in children; legally binding post-approval obligations; framework clear legal framework to evaluate emerging efficacy and safety data. “

“Every day counts: we work at full speed to authorize vaccines against Covid-19 that are safe and effective. I am pleased that the EMA has anticipated the meeting to discuss the Pfizer-BionTech vaccine, before Christmas. the first Europeans are vaccinated before the end of 2020 ”, commented the President of the European Commission. Ursula von der Leyen, via social network.

The European Commissioner for Health is also satisfied Stella Kyriakides. “Covid-19 vaccines are on the horizon. EMA is working tirelessly to finalize its evaluation of the safety and efficacy of the BionTech and Pfizer vaccine. I am pleased that the evaluation meeting was brought forward to December 21 – time is of the essence. , time saves lives, “he says via social network.