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The complete results of the human trials of the Covid-19 vaccine developed by the alliance between the American Pfizer and the German BioNTech were published this Thursday (10) in the New England Journal of Medicine, the best-known medical journal in the United States. . and confirmed the 95% effectiveness announced by the companies on November 18.
According to the data, the effectiveness was similar in all groups, regardless of age, sex, ethnic origin, weight or presence of pathologies.
The study also confirms the safety of the vaccine. Side effects such as discomfort around the injection site, fatigue and headache were common, but no serious safety concerns were found in the clinical trial, which has so far enrolled 44,000 people. Half received the vaccine and the other, a placebo.
Two editors of the New England Journal of Medicine noted in their editorial “minor problems” in the data, especially about a lack of knowledge about the vaccine’s ability to prevent asymptomatic forms of the disease.
But they concluded: “However, the test results are impressive enough to be valid in any analysis. It is a victory.”
On Thursday (10), a committee of experts convened by the FDA (American Medicines Agency) began to examine the data of the vaccine in public, with the aim of recommending or not its authorization for its launch on the market.
The FDA itself had released its detailed report on the efficacy and safety of the vaccine on Tuesday.
The agency noted that the Pfizer / BioNTech vaccine against Covid-19 met the necessary requirements to be distributed in the US, suggesting that it would soon give the product the green light.
The agency released two separate analyzes, one from its own team of scientists and one from vaccine manufacturers. The FDA cited several benefits of the immunizer, such as reducing the risk of Covid-19 shortly after the first dose and at least seven days after the second dose was given. The vaccine also reduces the risk of serious illness immediately after the first dose. This last piece of information is important, since there was concern that the vaccine would only prevent mild and moderate cases.
Regarding known risks related to immunization, the agency said the vaccine had few side effects in clinical trials. The most common were injection site reactions, tiredness, headache, muscle pain, chills, joint pain, and fever. Serious effects were rare and more common after the second dose and less common in adults under 55 years of age.
According to FDA analysts, testing will be needed in a greater number of Covid-19 patients to confirm that the vaccine is effective in preventing deaths. But flu vaccines, which reduce the occurrence of the disease, also reduce death rates.
Six volunteers died during the tests: two of them received the vaccine and four were in the placebo group. None of the deaths were related to the immunizer. At the request of the FDA, about half of the volunteers were followed for another two months for safety reasons and to verify the duration of protection.
US officials estimate that December vaccine deliveries will be sufficient for approximately 20 million people; about 24 million Americans are in priority groups.
Validation by a review committee comprised of independent scientists from Pfizer and the FDA is further confirmation of the test results and represents the highest level of scientific validation.
