EMA’s human medicines committee (CHMP) has started a “rolling review” of data on BNT162b2 vaccine for COVID-19 which is being developed by BioNTech in collaboration with Pfizer.
The CHMP’s decision to start the rolling review of BNT162b2 is based on preliminary results from non-clinical and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells that target the virus. This does not mean that a conclusion can be reached yet on the vaccine efficacy and safety because much of the evidence is still to be submitted to the committee.
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All the available data on the safety of the BNT162b2 vaccine as well as on its quality, such as its ingredients and the way it is produced, will also be reviewed by the CHMP.
The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. This should allow to accelerate the process than a regular evaluation due to the time gained during the rolling review.
Discover more about the EMA rolling review procedure by reading our last tips.
Stay tuned for further updates!