Pfizer says FDA side effects are similar to second dose

Pfizer says FDA side effects are similar to second dose

A healthcare worker administers the third dose of the Pfizer-BioNtech COVID-19 vaccine at a retirement home in Worcester, Pennsylvania, United States, Wednesday, August 25, 2021.

Hannah Baer | Bloomberg | Getty Images

In new data submitted to the Food and Drug Administration, Pfizer said the side effects of COVID vaccine booster shots are similar to those experienced after the second dose and are more likely to affect young people as it plans to dispense booster shots across the United States. . wants approval.

Pfizer’s phase three vaccine booster study, which included a group of nearly 300 participants aged 18 to 55, found that 63.7% were tired after receiving their boosters, 48.4 % had headaches. , and 39.1% experienced muscle pain. The company said in a 52-page report released by the agency on Wednesday that most reactions to the boosters were of mild or moderate severity. The company, along with BioNTech, is seeking emergency FDA approval to deliver a third dose of its vaccine to people 16 years of age and older across the United States.

Pfizer first assessed side effects on 2,682 second-dose recipients aged 16 to 55 and found that 61.5% developed fatigue, 54% headache and 39.3% pain. muscle.

The study also followed adverse events in 306 booster recipients, 44 of whom developed at least one unexpected side effect. The most common adverse event, swelling of the lymph nodes, occurred in 16 participants.



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