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  • Pfizer -BioNtech seeks...

Pfizer -BioNtech seeks USFDA nod for COVID vaccine boosters for adults

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-11-12T09:30:52+05:30  |  Updated On 12 Nov 2021 4:06 PM IST
Pfizer -BioNtech seeks USFDA nod for COVID vaccine boosters for adults
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New Delhi: Pfizer Inc 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 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 COVID-19 vaccine has been authorized for use as well. Roughly 25 million Americans had received a booster, as of Monday.

Moderna did not immediately respond to a Reuters request for comment.

Read also: USFDA delays nod to Moderna COVID vaccine for teenagers

pfizerpfizer newscoronavirus vaccinecovid19coronavirus
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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