Today will certainly be marked in the history of the COVID-19 pandemic. The Pfizer vaccine was administered to the first person in the world. Recall that the Pfizer / BioNTech vaccine was approved in the United Kingdom.
Experts from the North American drug agency consider that the vaccine from Pfizer and BioNTech does not present security risks that prevent authorization, which may occur at the end of the week.
COVID-19: Pfizer / BioNTech vaccine has “favorable safety profile” - FDA
Safety data for 38,000 participants in the COVID-19 vaccine clinical trial, who have had an average clinical follow-up of two months, "suggest a favorable safety profile" as no specific safety problem has been identified to prevent emergency clearance, write experts from the United States Food and Drug Administration (FDA) in a report released two days before a public meeting of the agency's vaccine advisory committee, reveals Lusa.
The most common side effects of the vaccine recorded in 43,252 participants, including children and adolescents aged 12 and over, were as follows:
- Topical reaction next to the immunization site (arm) (84.1%)
- Fatigue (62.9%)
- Headache (55.1%)
- Body pain (38.3%)
- Chills (31.9%)
- Joint pain (23.6%)
- Fever (14.2%).
Serious reactions occurred only in zero to 4.6% of the participants and were less common in people over 55 years old (2.8%) than in young people (4.6%). With regard to the degree of effectiveness of the vaccine, the American agency estimates it at 95%, as announced by Pfizer and BioNTech.
This new report highlights a new element with regard to the effectiveness of the vaccine for COVID-19, suggesting that it is not only effective for severe forms of infection with the new coronavirus, after the two inoculations, but also in preventing disease after taking the first dose.
The study also demonstrates effectiveness in people who had been infected with the new coronavirus before. The study stresses, however, that these cannot yet be taken as "definitive conclusions".
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