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Pfizer and its European partner BioNTech have asked the US Food and Drug Administration (FDA) to expand emergency authorization of its COVID vaccine to allow everybody 18 and older to get a booster dose.
If it goes through, the broader use of Pfizer boosters would be a step toward President Joe Biden’s goal of boosters for all adults. He announced the goal last August but backed off to let the regulatory process by the FDA and the Centers for Disease Control and Prevention (CDC) play out.
Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to a company news release.
This would be Pfizer’s second attempt. In September, an FDA advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.
However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.
The FDA and the CDC authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster six months after the second dose and people who got the one-dose J&J vaccine should get a booster two months later.
The pro-booster argument has strengthened because new data has come in from places like Israel that confirms boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID case counts and deaths are not dropping in every part of the country, though they are declining overall, The Post said.
The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post said.
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