EMA launches rolling review of a coronavirus (COVID-19) mRNA vaccine

Article summary

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has commenced the second rolling review of a coronavirus (COVID-19) vaccine (BNT162b2), developed by BioNTech in collaboration with Pfizer. The CHMP has begun evaluating the first batch of data from laboratory studies and will continue to review data as they become available on a 'rolling' basis ​until a sufficient amount is provided and the company is advised that a formal application for a marketing authorisation is submitted. Preliminary results from non-clinical and early clinical trials of BNT162b2 have shown that, when used in adults, the vaccine triggers production of antibodies and T-cells which target the virus. Large scale clinical trials are ongoing and results ‘will be available in the coming weeks and months.’