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Pfizer and BioNTech have released interim information on their Phase 3 COVID-19 vaccine trial.
Pfizer and BioNTech have released the interim analysis of their Phase 3 study of their COVID-19 vaccine candidate, BNT162b2.1 The Phase 3 study had 43,538 participants with 42% having a diverse background. During the course of the study, no serious safety issues have been found. There have been 94 confirmed cases of COVID-19 in the cohort and current analysis of the candidate shows that it is more than 90% effective in preventing COVID-19.
The trial will continue until there have been a total of 164 confirmed cases of COVID-19 in the participants. Additionally, the trial will look at whether the candidate can give protection to people who have had previous exposure to COVID-19. The safety data needed to meet the requirements for an Emergency Use Authorization by the US Food and Drug Administration will be available by the end of the third week in November. Participants will be monitored for safety concerns and long-term protection for 2 more years.
Pfizer indicates that 50 million doses of the vaccine would be produced in 2020 and 1.3 billion in 2021.
1. Pfizer. Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success in first interim analysis from phase 3 study. Pfizer.com. Published November 9, 2020. Accessed November 9, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against.