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Food and Drug Administration to Authorize Pfizer Vaccine for 12-15 Year Olds

According to The New York Times, the Food and Drug Administration plans to approve the use of Pfizer-COVID-19 BioNTech’s vaccine in adolescents aged 12 to 15 later this week or early next week. Unnamed federal officials who did not have permission to talk publicly about the FDA’s plans were quoted by the Times. If the Food and Drug Administration approves the vaccine for use in teenagers this week, the CDC’s vaccine advisory panel will possibly meet a day later to review the clinical trial results.

They will make a recommendation on use, according to the New York Times. In a small Phase III clinical trial, Pfizer announced on March 31 that the vaccine fully protected adolescents aged 12 to 15 against COVID-19. In this age group, the vaccine was also well-tolerated, with only minor side effects.

Food and Drug Administration to Authorize Pfizer Vaccine for 12-15 Year OldsIn the 2,260-person trial, the vaccine was given to 1,131 adolescents aged 12 to 15, while the placebo was given to 1,129. In the experiment, there were 18 cases of symptomatic COVID-19, all of which were treated with placebo. The vaccinated community tended to generate higher levels of neutralising antibodies than those seen previously in people aged 16 to 25, according to Pfizer.

Albert Bourla, Pfizer’s CEO, said, “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15. We plan to submit these data to Food and Drug Administration as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”

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