With its application, the company included early results of a study that involved 10,000 people
WEDNESDAY, Nov. 10, 2021 (HealthDay News) — As concerns mount that holiday travel and indoor gatherings will foster the spread of COVID-19, Pfizer on Tuesday asked the U.S. Food and Drug Administration to approve booster shots of its COVID-19 vaccine for any American aged 18 years and older.
With its application, the company included early results of a study that involved 10,000 people. That trial showed the booster was 95 percent effective against symptomatic infection, even as the delta variant raged across the country, the Associated Press reported.
A median of 11 months after their last Pfizer vaccination, trial participants were given either a third vaccine 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 with 109 cases among people who got dummy shots. Booster side effects were similar to those associated with the first two shots of the Pfizer vaccine.
Since September, only older Americans and those who are vulnerable to the virus because of underlying medical conditions or their job have been able to get a booster of the Pfizer vaccine.
FDA spokeswoman Alison Hunt told the AP that the agency would review the Pfizer application “as expeditiously as possible,” but would not set a timeline for a decision. She also said the FDA has not yet decided whether to convene its panel of outside experts to vet the latest data. If the FDA authorizes the Pfizer request for boosters for all American adults, the U.S. Centers for Disease Control and Prevention then will make recommendations on how to use them.
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