EMA begins second rolling review of a COVID-19 vaccine

The European Medicines Agency (EMA) has begun a ‘rolling review’ of data on a vaccine for COVID-19, which is being developed by BioNTech in collaboration with Pfizer.

Rolling review means the EMA can make progress based on Phase II and Phase I trial data while Phase III trials are ongoing, rather than requiring a complete set of data before pursuing marketing authorisation, as would be the conventional route. This should save time, meaning that the process for an evaluation should be shorter.

The EMA’s press release confirms that

“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 (cells of the immune system, the body’s natural defences) that target the virus.

“Large-scale clinical trials involving several thousands of people are ongoing, and results will become available over the coming weeks and months. These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed once they are available. All the available data on the safety of the vaccine as well as on its quality (such as its ingredients and the way it is produced) will also be reviewed.

“The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.”

Read the EMA article for more information.

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Published on 7. October 2020 in News, News EU, Press Release