Tag: Pfizer

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Pfizer Says Final data Shows Covid Vaccine is 95% Effective ,Will Submit to FDA in coming ‘days’

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NEW YORK & MAINZ, Germany,  Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine 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 COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.

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PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED 90% SUCCESS RATE

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Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants

Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected

Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November

Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

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COVID19 : LATEST VACCINE CLINICAL TRIALS

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Oxford UK,  according to Johns Hopkins Center for Health Security, less than a week after suspending Phase 3 clinical trials for its candidate SARS-CoV-2 vaccine due to a serious adverse event, AstraZeneca announced that the trials have resumed in the UK. According to a press release issued by AstraZeneca, the trials resumed after the UK government’s Medicines Health Regulatory Authority (MHRA) evaluated the evidence and determined that it was safe to continue testing the vaccine. The press release states that AstraZeneca and the University of Oxford are not permitted to “disclose further medical information” regarding the adverse event, presumably including the associated safety data reviewed by MHRA or the results of their analysis. It appears that the Phase 3 trials in other countries remain on hold.

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