European Medicines Agency Does Speedy Review in Pfizer’s Phase 3 Vaccine Trial
Oct. 6, 2020 (EIRNS)—Pfizer/BioNTech stated earlier this month that the data from their Phase 3 testing of their COVID-19 vaccine will be reviewed by the European Medicines Agency on a rolling basis, meaning that it will be reviewed continuously. The European Union’s EMA reported details in a release “EMA Starts Second Rolling Review of a COVID-19 Vaccine,” on its website today. This continuous review process is in stark contrast to the usual research protocol reviews, which average every two months. The continuous review process will greatly speed the approval of the vaccine as soon as enough COVID-19 case reports come in from the study groups. The coverage from MarketWatch states that the decision “follows the encouraging preliminary results from pre-clinical and early clinical trials in adults.” These reviews are conducted by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The EMA is the European Union equivalent of the U.S. Food and Drug Administration, and reports to the European Commission. The European Center for Disease and Prevention figures show that Europe is currently experiencing a surge of COVID-19.