Pfizer Inc. and BioNTech SE said the European Medicines Agency has decided to review data from their COVID-19 vaccine candidate on a rolling basis and has already started to evaluate data from pre-clinical trials. The decision “follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2,” the companies said in a joint statement. That combination of antibody and T Cell response is viewed as an important protection against viral infection and disease. A formal Marketing Authorization Application may follow if the vaccine proves efficacious and safe and submitted data are adequate, the statement said. The vaccine candidate is currently in a Phase 3 trial at more than 120 clinical sites around the world and has enrolled about 37,000 participants. “By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the investigational medicine or vaccine should be authorized,” the companies said. “After a positive opinion, if adopted by the CHMP, it is the European Commission’s role to grant a Marketing Authorization.” Pfizer shares were up 2% premarket, while BioNTech shares were up 10%.
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