Pfizer seeks FDA nod for COVID vaccine boosters for U.S. adults

Pfizer Inc (PFE.N) and BioNTech on Tuesday requested the U.S. Food and Drug Administration (FDA) to authorize booster doses of their COVID-19 vaccine in all adults, presenting recent data showing the shot would help prevent disease across ages.

Over the past several months, the FDA has authorized Pfizer’s boosters for people who are immunocompromised, those who are aged 65 and above, all people at high risk of severe disease, and people who are regularly exposed to the virus.

Pfizer previously requested authorization for all people aged 16 or over, but the FDA held back on extending boosters to everyone, partly because there was not enough evidence of waning immunity or of the benefit of boosters in younger people.

Pfizer said it would present data from a large clinical study which last month showed that a booster dose of its vaccine was 95.6% effective against the coronavirus when compared to a vaccinated group that did not get the third shot.

The company and U.S. health officials have argued that boosters prevent hospitalizations and deaths and that they can slow mild infections as well.

U.S. President Joe Biden’s administration in August announced plans to roll out booster doses for all adults in September, before the FDA’s advisers had recommended a limited authorization.

Moderna (MRNA.O) is likely to file a request with the U.S. FDA to broaden emergency use authorization of its boosters in all adults, CNBC reported on Tuesday, citing sources familiar with the matter, but said the timing of the filing was not known yet.

Moderna’s booster doses have been cleared for use in a similar group of patients to Pfizer’s, and a booster shot of Johnson & Johnson’s (JNJ.N) COVID-19 vaccine has been authorized for use as well. Roughly 25 million Americans had received a booster, as of Monday.

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