woodguru wrote:
Actually the reason was the undue and entirely inappropriate pressure trump has put on every agency that is supposed to be the ones calling the shots, and that includes the FDA. And the reality is that the v*****e trials are nowhere near fully seasoned as in giving statistics of all kinds a chance to reveal realities and facts.
I feel better about those who refused to come in with trump's operation warp speed because they did not want the appearance that they were pressured to skip steps in order to make trump happy with earlier rather than safer. There is also a factor that money was invested in production before knowledge of any efficacy, which would give companies strong motivations to monkey with trials results.
Actually the reason was the undue and entirely ina... (
show quote)
You never miss an opportunity to take a s**t on anything that could benefit everyone.
Newsflash! With OWS, President Trump created a competitive environment, you know, one of those Free Market Capitalism things where companies compete.
No body is forcing you to get v******ted. Apparently you'd prefer millions more people get infected and die.
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%.
To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the v*****e. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the v*****e was well tolerated, with most solicited a*****e e***ts resolving shortly after v******tion. The only Grade 3 (severe) solicited a*****e e***ts greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited a*****e e***ts following v******tion.
In addition, the companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for E*******y Use A***********n (EUA) has been achieved. P****r and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the v*****e. These data also will be submitted to other regulatory agencies around the world.