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The phase results of the Pfizer-BioNtech vaccine, already licensed in Great Britain and Canada, are public. The Covid-19 vaccine that has been “tested” in 43,548 people, half of whom received the vaccine, is 95% effective (with a range between 90.3% and 97.6%) sigliaBNT162b2) and half of the placebo. The results are published in the New England Journal of Medicine. Adverse events included mild to moderate and temporary infection site pain, fatigue, and headache. The incidence of serious adverse events was low and similar in the groups that received the vaccine and those that received placebo. The trial was conducted in people 16 years of age and older who received two doses 21 days apart. Of these, 21,720 were treated with the vaccine and 21,728 with placebo. There have been eight cases of Covid-19 with onset at least 7 days after the second dose between the first and 162 between the second, therefore, the scientific publication concludes, the vaccine was 95% effective in preventing Covid-19 .
Meanwhile, the expert committee of the Food and Drug Administration (FDA), the US regulatory body, in a meeting open to the public will most likely vote this afternoon on its recommendations on the US approval of the Sars Cov 2 vaccine. If the commission gives, as expected, a favorable opinion, the FDA should launch the emergency authorization of the first vaccine within a couple of days. The committee includes scientists who study vaccines and infectious diseases, representatives from other agencies, as well as pharmaceutical industries and consumers. The Advisory Committee on Vaccines and Related Biologicals is made up of 17 permanent and 13 rotating members.
Just yesterday, Biontech announced that the second generation of the vaccine could be ready already in the second half of 2021. The company is working on the new compound. that can be transported at room temperatureinstead of the current -70 degrees, a condition that makes transportation logistically complicated. The researcher also “believes that by the summer there will be enough doses of the vaccine so that around 60-70% of the German population will be immunized.”
The Nejm study
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