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The first analysis by the US Food and Drug Administration (FDA) of clinical trial data for the Pfizer Covid-19 vaccine showed that the product worked well regardless of race, weight or age.
The FDA issued a statement Dec. 8 during a meeting of its vaccine advisory committee, based on the agency and Pfizer-BioNTech’s own 100-page review document. Last month, two pharmacists announced that the injections were 95% effective, effective after two doses three weeks apart. The FDA’s analysis showed that vaccine protection came into play much earlier.
The vaccine worked well regardless of the volunteer’s race, weight, or age. Typical side effects are swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever. This is a common manifestation of vaccines. The most serious adverse reactions are quite rare, generally occur after the second nose, and are rare in people over 55 years of age.
The FDA concludes that the Pfizer vaccine “meets the regulatory criteria for clinical research.”
According to the FDA analysis, in addition to the known effects, the injections “reduce the risk of nCoV infection for at least 7 days after the second injection” and especially “reduce the risk of severe Covid-19 weight after the first nose “. This is extremely important, as critics of the vaccine often argue that vaccination prevents only mild to moderate infections.
FDA documentation provides more detailed information on vaccine safety. In clinical trials, some vaccinated people experienced abnormalities, but not related to the vaccine. The vaccinated group experienced no significant side effects compared to those who took the placebo. But the FDA noted that four volunteers had experienced facial paralysis, called Bell’s palsy. Everyone receives vaccinations.
On December 10, the FDA’s vaccine advisory committee will discuss more about the latest analysis before voting for an urgent approval. The agency said it would only approve vaccines that were at least 50% more effective than a placebo. The trial volunteers needed to be monitored after about two months to ensure that rare side effects did not occur.
Thuc Linh (According to the The Times of New York City)
