EMA Commences Rolling Review of Second COVID-19 Vaccine

AMSTERDAM, The Netherlands – The European Medicines Agency’s (EMA) human medicines committee (CHMP) has commenced a rolling review of data for Pfizer and BioNTech’s potential COVID-19 vaccine candidate, BNT162b2.

This is the Committee’s second rolling review of a COVID-19 vaccine. Last week, EMA announced it had initiated a rolling review for AstraZeneca and the University of Oxford’s vaccine candidate.

Regarding the Pfizer and BioNTech vaccine, the Committee has started evaluating the first batch of non-clinical data. However, a conclusion on its safety and efficacy cannot yet be reached, as the Committee is still waiting on further evidence.

CHMP’s decision to start the rolling review of BNT162b2 is based on promising preliminary results from non-clinical trials and early clinical studies, in which it has been suggested that the vaccine triggers the production of antibodies and T cells targeting the coronavirus.

Large-scale trials with several thousands of participants remain ongoing, with results expected to become available over the coming months. From these results, the Committee will be able to analyze the efficacy of the vaccine in protecting people from COVID-19.

The rolling review is set to continue until there is sufficient evidence to support a formal marketing authorization application. While EMA cannot forecast a specific date for approval, the process will take less time than a regular review because of the rolling review.

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