Pfizer tells FDA side effects are similar to second dose
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A healthcare worker administers a third dose of the Pfizer-BioNTech Covid-19 vaccine at a senior living facility in Worcester, Pennsylvania, U.S., on Wednesday, Aug. 25, 2021.
Getty Images Side effects from Covid vaccine booster shots are similar to those felt after the second dose and are more likely to affect younger people, said in new data submitted to the Food and Drug Administration as it seeks approval to distribute booster shots across the U.S. Pfizer’s phase three study of vaccine booster doses, which included a group of about 300 participants from ages 18 to 55, found that 63.7% experienced fatigue after getting their boosters, 48.4% had headaches and 39.1% felt muscle pain.| Bloomberg | Getty Images
Side effects from Covid vaccine booster shots are similar to those felt after the second dose and are more likely to affect younger people, Pfizer said in new data submitted to the Food and Drug Administration as it seeks approval to distribute booster shots across the U.S.
Pfizer’s phase three study of vaccine booster doses, which included a group of about 300 participants from ages 18 to 55, found that 63.7% experienced fatigue after getting their boosters, 48.4% had headaches and 39.1% felt muscle pain. In a 52-page report, Pfizer stated that most reactions to boosters were either mild or moderate. The company, along with BioNTech, are seeking the FDA’s emergency approval to administer third doses of its vaccine to people 16 and over across the U.S.
Pfizer previously evaluated side effects on 2,682 second-dose recipients ages 16 to 55 and found that 61.5% developed fatigue, 54% suffered headaches and 39.3% dealt with muscle pain.
The adverse effects of 306 boosters were also monitored. 44 people experienced at least one side effect. Swelling of the lymph nodes was the most frequent adverse event in the study. It occurred in 16 participants.
According to the report, there was no evidence of anaphylaxis and hypersensitivity in phase three. Pfizer also stated it had not found any new adverse drug reactions related to booster.
A report found that 29% of booster recipients felt chills while 25% experienced joint pain. The number of people reporting fever fell by half in between the first and third doses. 16.4% reported symptoms of fever in the second study, while 8.7% in the booster.
President Joe Biden has said he plans to begin distributing booster shots by Sept. 20, but the FDA on Wednesday declined to take a stance on supporting Pfizer’s Covid boosters. According to an FDA report, the FDA hasn’t yet verified independently the conclusions and data from the studies about the effectiveness of Pfizer’s boosters.
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