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Pfizer and BioNTech have asked the Food and Drug Administration to allow their COVID-19 booster injection to all people 18 years and older.
The companies say the request is based on results of a survey of more than 10,000 volunteers showing a vaccine effectiveness of 95% or greater for people receiving the booster.
The two companies filed a similar request in September, but at the time a committee of independent experts who advise the FDA on vaccine matters voted against.
Instead, the committee recommended offering the vaccine to people over 65 and young people at increased risk of a severe case of COVID-19 due to an underlying medical condition, job or living situation.
The FDA decided to follow the committee’s advice.
The results of the companies’ booster research were not available to the committee when it issued its advice.
According to the Centers for Disease Control and Prevention, nearly 25 million people in the United States have received a COVID-19 booster shot, or about 13% of the U.S. population. More than 30% of the over-65s have received a booster.
It’s not entirely clear how many more people would qualify for a booster if the FDA grants the Pfizer-BioNTech request.
The “underlying medical” conditions that already make some people eligible for a vaccine are quite broad: people with mental illness, smokers or former smokers, people who are overweight or obese to name a few.
Jobs in a high-risk environment are also defined quite broadly, including first responders, teachers, day care workers, factory workers, and grocery clerks.
A third dose of the vaccine was made available to certain immunocompromised people in August.
Anecdotal evidence suggests that many drugstores that supply the boosters are unscrupulous about making sure people fall into one of the allowed categories.
The FDA has not scheduled a meeting of its independent advisory committee for November, suggesting the agency can make its own decision on the Pfizer-BioNTech without taking outside advice.