European Medicines Agency Does Speedy Review in Pfizer’s Phase 3 Vaccine Trial

Pfizer/BioNTech stated earlier this month that the data from their Phase 3 testing of their Covid-19 vaccine will be reviewed on a rolling basis, meaning that it will be reviewed continuously. Details were reported Oct. 6 by Market Watch. 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 states that the decision “follows the encouraging preliminary results from pre-clinical and early clinical trials in adults.” These reviews are conducted by the Committee for Medicinal Products for Human Use, which is within the European Medicines Agency. The EMA is the European equivalent of the U.S. FDA, and reports to the EU’s European Commission. It is noted that Europe is currently experiencing a surge of Covid-19.