The Ridgewood Blog Brings a Free Market Laissez-faire Point of View to Local, New Jersey State and National Issues.
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Ridgewood NJ, the U.S. Food and Drug Administration (FDA) has announced major changes to how annual COVID-19 boosters are approved in the U.S., signaling a shift in vaccination policy that could limit eligibility to older adults and high-risk individuals. The new guidance, published in the New England Journal of Medicine, emphasizes the need for new clinical trials before extending yearly COVID-19 vaccines to healthy Americans under age 65.
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Ridgewood NJ, BioNTech has been testing the use of mRNA vaccines against cancer. Animal trials have shown great promise, so the technology is now in human trials to see if they can bring the same success. Cytokines are proteins with anti-tumor effects. Research has shown that they can shrink tumors and even eradicate them, but they have a short half-life, and high levels of cytokines in the body results in adverse effects. The experimental vaccines encode cytokines directly into the tumors, creating them in large quantities without adverse effects.
Continue reading BioNTech mRNA Cancer Treatment Moved To Human Trials After Success In Mice
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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%.
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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