U.S. FDA may approve COVID-19 booster without outside advisory panel opinion -CNN – Yahoo News

(Reuters) -The U.S. Food and Drug Administration is unlikely to ask its outside vaccine advisers to weigh in on whether the agency should authorize Pfizer COVID-19 boosters for all adults, CNN reported on Friday, citing a source.

The source told CNN “it’s unlikely there is going to be a meeting” of the outside advisers and “there has been no discussion of a meeting” to discuss Pfizer’s application.

The FDA said the agency “will determine whether to hold a meeting of the advisory committee … following its initial review of the information submitted,” CNN added https://cnn.it/3wH3GeS.

Pfizer and BioNTech on Tuesday requested the FDA to authorize booster doses of their COVID-19 vaccine in all adults, presenting 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.

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.

(Reporting by Kanishka Singh in BengaluruEditing by Chris Reese and Grant McCool)

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