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Pfizer, BioNTech say study of COVID-19 patients six months after second vaccine dose proved it is safe and effective
April 1, 2021 at 09:04
"It is an important step to further confirm the strong efficacy and good safety data we have seen so far," BioNTech CEO Ugur Sahin said.
Pfizer Inc. PFE, +0.33% and German partner BioNTech SE BNTX, +4.55% said Thursday a study of COVID-19 patients six months after receiving a second dose of their vaccine BNT162b2 confirmed its high efficacy and lack of serious safety concerns. The companies said an analysis of 927 confirmed symptomatic cases of COVID-19 showed the vaccine had a 91.3% efficacy against the illness, measured seven days through up to six months after the second dose. The vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration. The vaccine also proved to be 100% effective in preventing COVID-19 cases when used against the South African variant, which is more infectious than the original virus. Experts have worried that new variants might prove more resistant to the vaccines that have won emergency use authorization from regulators. Pfizer and BioNTech said they have now evaluated vaccine safety in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after a second dose. "These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," said Pfizer Chief Executive Albert Bourla. Prizer shares were up 0.2% premarket, while BioNTech shares were up 1.2%.
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