EMA Starts Review of Pfizer/BioNTech COVID-19 Vaccine Candidate

The European Medicines Agency (EMA) began its second expedited review of a COVID-19 vaccine candidate, starting its evaluation of data for Pfizer/BioNTech’s vaccine hopeful BNT162b2 on Tuesday.

The agency said that its Committee for Medicinal Products for Human Use (CHMP) decided to begin the review after preliminary results from nonclinical and early clinical studies in adults suggested that the vaccine elicits the production of virus-targeting antibodies and T cells.

The vaccine, which is currently in phase 3 trials, is one of the furthest along and looks to be on track for an FDA submission for an Emergency Use Authorization this month (DID, Oct. 5). So far, Pfizer has recruited more than 37,000 participants for the trials in multiple countries and more than 28,000 have received their second vaccination, the company said.

The “rolling review,” as the EMA calls it, is meant to accelerate assessment of the vaccine, as the agency will review data as it becomes available from ongoing trials rather than waiting for a completed application to be filed.

The agency last week began a rolling review of AstraZeneca’s vaccine candidate, whose late-stage trial remains on hold in the U.S. over a safety event in a UK trial, although it has resumed in the UK, the EU and elsewhere (DID, Oct. 2).

The EMA said 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,” the agency said. — James Miessler