Pfizer asks FDA to authorize COVID-19 vaccine booster for adults of all ages

Pfizer announced that it had, along with its partner BioNTech, requested that the FDA give emergency authorization to the Covid-19 vaccine booster for eligible adults of all ages.

On Tuesday, a joint statement from Pfizer and BioNTech said that based on the results of the Phase 3 trial, the companies were asking the CDC to amend its emergency use authorization for the Pfizer-BioNTech booster. If the request is granted, adults 18 years and older who got the second shot at least six months ago would be eligible for the booster. 

In the statement, the companies said “The amendment request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-μg booster dose of the vaccine, which enrolled more than 10,000 participants during a period when the Delta variant was the prevalent strain.”

Last month, Pfizer and BioNTech announced that they saw results showing that those who received the booster after getting the first two shots had a relative efficacy of 95% and fared better than those who did not receive the booster. “There were 5 cases of COVID-19 in the booster group, and 109 cases in the non-boosted group.”

In September, an external advisory board voted unanimously to recommend the booster for those who are elderly, have medical issues, or frequently in high-risk environments, like healthcare workers. The board voted against recommending the booster to anyone 16 and up. Soon after, the FDA granted emergency authorization of the Pfizer-BioNTech Covid-19 booster for the groups the advisory board had recommended. 

The FDA recently authorized the Pfizer-BioNTech vaccine for children aged 5-11. So far, almost one million children in that age group have gotten their first shot. Trials showed that the vaccine was 91% effective at preventing Covid-19 infections riddled with strong symptoms.




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