Pfizer/BioNTech COVID-19 Vaccine Is 95% Effective
The clinical trial safety and efficacy results from Pfizer/BioNTech’s vaccine for the virus that causes COVID-19 are now in and they are impressively positive. In the trial, 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus eight in the vaccine group. Nine severe cases of COVID-19 occurred in the placebo group, whereas only one such case was observed among the vaccinated group. Based on these figures, the vaccine is 95 percent effective against COVID-19. The companies further report that “efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94 percent.” The independent data monitoring committee for the trial identified no significant safety concerns with the vaccine.
The companies announced that they plan to submit a request within days to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA). These data will be reviewed in a public session by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to the issuance of any EUA for a COVID-19 vaccine. The VRBPAC is composed of nongovernment scientists, physicians, and other experts who make recommendations for or against regulatory approval based on their evaluation of the benefits and risks of candidate vaccines. Taking into account the committee’s recommendation
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