The European Medicines Agency (EMA) has started a rolling review of a second SARS-CoV-2 vaccine. The process will see the EMA’s Committee for Medicinal Products for Human Use (CHMP) review safety and efficacy data as they become available in order to speed up the regulatory process.
Last week Univadis reported that the EMA had started a rolling review of data on the AZD1222 ChAdOx1 vaccine being developed by AstraZeneca and Oxford University in the UK. A rolling review has now been started on the BNT162b2 vaccine being developed by BioNTech in collaboration with Pfizer.
The 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. Large-scale clinical trials involving several thousands of people are ongoing.
The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.
The EMA says it will complete its assessment according to its usual standards for quality, safety and effectiveness. While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review.