In the first interim efficacy study, vaccine candidates were shown to be more than 90 per cent successful in preventing COVID-19 in participants without evidence of previous SARS-CoV-2 infection.
In the trial subjects, the study examined 94 reported cases of COVID-19
43,538 participants were included in the study, with 42 percent having different backgrounds and no significant safety issues were noted; safety and additional effectiveness data continue to be obtained.
Submission to the United States for Emergency Use Authorization (EUA)
NEW YORK & MAINZ, GERMANY—(BUSINESS WIRE)—Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced their candidate mRNA-based vaccine, BNT162b2, for SARS-CoV-2 has demonstrated proof of efficacy against COVID-19 in participants with no previous evidence of SARS-CoV-2 infection, based on the first interim efficacy review performed on 8 November 2020 by an external, unbiased analysis of efficacy against COVID-19.
Following consultations with the FDA, the organizations have recently opted to withdraw the 32-case interim review and perform the first interim analysis in at least 62 instances. The evaluable case count hit 94 at the end of those discussions and the DMC conducted its first report on all cases. A vaccine effectiveness score of 90 percent at 7 days after the second dose is demonstrated by the case split between vaccinated individuals and those who got the placebo. This implies that 28 da da defense is accomplished.