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The FDA notes that the vaccine, BNT162b2, is safe regardless of age, sex, nationality, or the initial presence of pathologies.
American experts Food and Drug Administration (FDA) estimates in a report published today that his vaccine Pfizer and BioNTech against Covid-19 did not present a security risk that would prevent its approval, which could be decided at the end of the week.
The security data of 38,000 participants in the clinical trial of the vaccine with a two-month follow-up “indicate a favorable safety profile, without identifying a specific safety problem that would prevent” emergency clearance, FDA experts wrote in a report published two days before a public meeting of the US advisory committee. the agency on vaccines.
The most common side effects They were the following ones in 43,252 participants, including children and adolescents 12 years and older: reactions around the injection site in the hand (84.1%), fatigue (62.9%), headache (55.1%), myalgia (38.3%)%), chills (31.9%), joint pain (23.6%), fever (14.2%).
Serious reactions occurred in 0 to 4.6% of the participants and was less common in people older than 55 years (2.8%) than in young people (4.6%).
Serious side effects, that is, requiring hospitalization, were very rare throughout the clinical trial (less than 0.5%) and were as common in the placebo group as in the vaccinated group, suggesting that the vaccine was irrelevant.
Except undesirable side effects in people under the age of 55, undoubtedly due to the fact that the immune system of younger people is generally more active, the FDA notes that the vaccine, BNT162b2, is safe regardless of age, sex, nationality or presence of pathologies. In terms of efficacy, the FDA confirms the very high level of efficacy of the vaccine at 95%, which was announced by the Pfizer and BioNTech.
According to the APE-MPE, a new element emerged in this analysis: the vaccine appears to be not only very effective in preventing severe forms of Covid-19 after two doses, but also in preventing Covid-19 after the first dose, as well as at those who had been infected before coronavirus, “Although the data available for these results do not allow to draw definitive conclusions.”
THE FDA predicts it will wait for the committee meeting on Thursday before making a decision on whether or not to approve the vaccine, which has already been approved in Britain and other countries.
