Despite data breach, CHMP set to consider Pfizer-BioNTech COVID vaccine

Regulatory NewsRegulatory News | 15 December 2020 |  By 

A committee of the European Medicines Agency (EMA) has moved up a meeting to evaluate the COVID-19 vaccine developed by Pfizer and the German firm BioNTech. EMA’s human medicines committee (CHMP) announced on 15 December that an exceptional meeting is now scheduled for 21 December, with a placeholder kept for the original 29 December date if more time for evaluation is needed.
“The rate of progress 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,” noted EMA in a press release announcing the accelerated schedule.
The Pfizer-BioNTech messenger RNA (mRNA) vaccine has been under rolling review by CHMP since 6 October. The UK’s MHRA issued temporary authorization for the Pfizer-BioNTech vaccine’s use on 2 December, and the US Food and Drug Administration issued an emergency use authorization on 11 December. Bahrain, Canada and Mexico have also given authorization or approval for the vaccine to be administered. (RELATED: COVID-19 vaccine tracker, Regulatory Focus 14 December 2020)
The CHMP evaluation process will be concluded “only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” wrote EMA. If CHMP recommends a marketing authorization, the European Commission is planning  speedy progress to an EU- and European Economic Area-wide authorization “within days.”
The coordinated approach will allow for coordination of vaccination campaign efforts and enhance the ability of regulators to benefit from a unified approach, said EMA.
The news of the accelerated timeline for Pfizer’s vaccine candidate comes as EMA acknowledged that some documents in the Pfizer-BioNTech submission packet were “unlawfully accessed.” In a joint statement, the two firms said that the documents in question were housed on an EMA server; “we are unaware that any study participants have been identified through the data being accessed,” they wrote. The attacks will not affect the timeline for review of the firms’ application for marketing authorization of the vaccine, said EMA.  


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Tags: coronavirus, EMA, EU

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