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Pfizer Asking FDA to Approve COVID-19 Booster Shots for All Adults

November 9, 2021 by Dan McCue
Vials of the Pfizer-BioNTech COVID-19 vaccine sit in a cooler before being thawed at a pop-up COVID-19 vaccination site in the Bronx borough of New York on Tuesday, Jan. 26, 2021. (AP Photo/Mary Altaffer, File)

WASHINGTON — Pfizer and BioNTech SE asked the Food and Drug Administration Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older.

Currently, COVID-19 booster shots are only available to older Americans and those with underlying health conditions that make them particularly vulnerable to the virus.

In September, the FDA’s scientific advisors rejected a request to recommend extra doses of the Pfizer-BioNTech vaccine for everyone, saying it wasn’t convinced healthy young people needed one, especially when much of the world’s population remains unvaccinated.

At the same time, the agency said it would quickly expand booster shots to other adults if warranted.

In a press release, the two 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.

More than 10,000 people participated in the trial, which was carried out when the Delta variant was the prevalent strain of the virus.

In October, the companies announced positive top-line results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. 

Side effects were similar to those seen with the company’s first two shots.

“Thus far, these are the first and only efficacy data disclosed from any randomized controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified,” the companies said.

A median of 11 months after their last Pfizer vaccination, trial participants were given either a third dose or a dummy shot. 

Researchers tracked any infections that occurred at least a week later, and so far have counted five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who got dummy shots.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

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