EMA Begins Review of AstraZeneca’s COVID-19 Vaccine
The European Medicines Agency has begun a “rolling review” of AstraZeneca’s vaccine candidate AZD1222, in which the agency’s expert advisory committee on human medicines will assess data from early studies.
The agency said preliminary data indicated the vaccine candidate spurs the production of antibodies and T-cells targeting the SARS-CoV-2 virus that causes COVID-19. The early results from phase 1 and 2 trials showed no serious adverse events linked to the vaccine.
Phase 3 testing has resumed in the EU following a hold last month after an adverse event in one trial participant. In the U.S., the trial has been paused while regulators learn more about what caused the adverse event.
Despite the recent suspension of the phase 3 study, AstraZeneca CEO Pascal Soriot said that the vaccine could still be ready by the end of the year.