Pfizer, BioNTech seek broader FDA approval for COVID-19 vaccine booster

Pfizer and BioNTech on Tuesday asked the Food and Drug Administration to expand its emergency use authorization for a COVID-19 booster shot to all individuals 18 years old and older.

The existing EUA for Pfizer booster shots applies only to individuals 65 years old and older; 18 years old and at a higher risk for severe COVID-19 due to existing medical conditions; or those whose jobs put them at a higher risk of contracting the novel coronavirus. The FDA approved the booster shot to be given at least six months after the first two-dose regimen.

The request seeks to expand the EUA to all individuals 18 and older regardless of risk.

Pfizer said clinical trials of its vaccine show that a booster shot increases protection against symptomatic infections to 96%.

Unnamed health officials told The Washington Post the request could be approved by the end of November.

According to the Centers for Disease Control and Prevention, 224.26 million people are fully vaccinated in the United States and 67.5% of the U.S. population has received a booster dose of the COVID-19. The FDA has also given EUA to booster doses of the Moderna and Johnson & Johnson COVID-19 vaccines.

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