Regulatory Review of COVID-19 Vaccine Begins in Europe

The European Medicines Agency (EMA) announced on October 1, 2020 that its human medicines committee (CHMP) has begun evaluating the first batch of laboratory study data on the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford. EMA stressed that a conclusion would not be reached based on these early data because additional evidence still needs to be submitted to the agency.

Typically, the CHMP reviews all of a medicine’s data when it is submitted at the start of the formal application process. EMA may use a ‘rolling review process’ instead during a public health emergency to assess data about a drug or vaccine as the data become available. CHMP then decides when there are sufficient data for a formal application to be submitted for review. EMA expects the evaluation process of the vaccine to be shorter because of the time gained by the rolling review.

“The CHMP’s decision to start the rolling review of the vaccine is based on preliminary results from non-clinical and early clinical studies suggesting that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defenses) 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 in later rolling review cycles. All the available data on the safety of the vaccine emerging from these studies, as well as data on its quality (such as its ingredients and the way it is produced), will also be reviewed,” the agency stated in a press release.