JFlorio wrote:
Wonder just how effective a v*****e will be.
P****r and BioNTech Conclude Phase 3 Study of C****-** V*****e Candidate, Meeting All Primary Efficacy EndpointsWednesday, November 18, 2020 - 06:59am
Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against C****-** beginning 28 days after the first dose;170 confirmed cases of C****-** were evaluated, with 162 observed in the placebo group versus 8 in the v*****e group
Efficacy was consistent across age, g****r, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
Safety data milestone required by U.S. Food and Drug Administration (FDA) for E*******y Use A***********n (EUA) has been achieved
Data demonstrate v*****e was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 a*****e e***t greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
The companies expect to produce globally up to 50 million v*****e doses in 2020 and up to 1.3 billion doses by the end of 2021
P****r is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the v*****e around the world
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- P****r Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their m**A-based C****-** v*****e candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a v*****e efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of C****-**, as specified in the study protocol, of which 162 cases of C****-** were observed in the placebo group versus 8 cases in the BNT162b2 group.
Efficacy was consistent across age, g****r, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.