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13, 2020 /--- -- The full results of the Pfizer-BioNTech COVID-19 vaccine BNT162b2 clinical trial were published in the journal New England Journal of Medicine under the title "Safety and Efficacy of BNT162b2 mRNA Covid-19 Vaccine," according to a new report.
this is an important milestone because a committee of the U.S. Food and Drug Administration (FDA) met to discuss the approval of the vaccine.
photo from New England Journal of Medicine, 2020, doi:10.1056/NEJMoa2034577.
an editorial in response to the paper,
The results of this cross-border, placebo-controlled, single-blind, critical-efficacy clinical trial are impressive enough to support any conceivable analysis."
's a victory.
clinical trial included nearly 44,000 volunteers, thousands more than previously analyzed.
about half of the people were vaccinated, and the rest received a placebo.
paper confirmed that the two-dose vaccination programme for BNT162b2 was 95% effective in preventing SARS-CoV-2 infection.
also notes that the vaccine works similarly "among people of all ages, genders, races, ethnicities, and whether or not the disease exists."
of the 10 cases of severe COVID-19 after receiving the first dose, 9 occurred in patients receiving a placebo and 1 in patients who received the vaccine.
the editorial also mentions some "minor problems": "The number of severe COVID-19 cases (1 in the vaccine group and 9 in the placebo group) is too small to draw any conclusions about whether the rare cases that occur in vaccinators are really more severe."
" other problems include whether unexpected security problems arise when the number of people vaccinated grows to millions, perhaps even billions.
It is also unknown whether there will be more side effects as follow-up time increases, how long the vaccine will remain effective, whether it will limit transmission, and how it will play a role in children, pregnant women and immunodeficiency patients.
(Bioon.com) Reference: 1. Fernando P. Polack et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine, 2020, doi:10.1056/NEJMoa2034577.2.Eric J. Rubin et al. SARS-CoV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention. New England Journal of Medicine, 2020, doi:10.1056/NEJMe2034717.3.Pfizer vaccine results published in peer-reviewed journal。