Pfizer and BioNTech SE’s mRNA-based vaccine candidate BNT162b2 is 90% effective in preventing COVID-19 in participants without prior evidence of SARS-COV-2 infection, according to the company’s press release. The results are based on the first interim efficacy analysis done on November 8, 2020, from the Phase 3 clinical study.
- Pfizer and BioNTech clinical trials will continue through to final analysis at 164 confirmed cases, up from the current 94, to collect further data and characterize the vaccine’s performance.
- Planned submission of BNT162b2 for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) is expected after the required safety threshold is achieved, likely to occur in the third week of November.
- The current study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns were observed.
Pfizer and BioNtech stocks are currently gaining. PFE: NYSE is up on premarket 12.20%, BNTX: NASDAQ is up on premarket 21.38%