US FDA may approve COVID-19 booster without outside advisory panel advice – CNN – Community News
Covid-19

US FDA may approve COVID-19 booster without outside advisory panel advice – CNN

A nurse fills syringes for patients receiving their booster vaccination against coronavirus disease (COVID-19) at a Pfizer-BioNTech vaccination clinic in Southfield, Michigan, US, Sept. 29, 2021. REUTERS/Emily Elconin

Nov 12 (Reuters) – The U.S. Food and Drug Administration is unlikely to ask its outside vaccine advisors to assess whether the agency Pfizer (PFE.N) should approve COVID-19 boosters for all adults, CNN reported Friday, citing to a source.

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

The FDA said the agency “will determine whether to hold an advisory committee meeting … after the initial review of the information submitted,” CNN added.

Pfizer and BioNTech on Tuesday asked the FDA to approve booster doses of their COVID-19 vaccine in all adults, showcasing data showing the injection would help prevent disease over the centuries. read more

In recent months, the FDA has approved Pfizer’s boosters for people who are immunocompromised, people age 65 and older, all people at high risk for serious illness, and people who are regularly exposed to the virus.

Pfizer previously requested authorization for all people 16 years of age or older, but the FDA has held back from providing boosters to anyone, in part because there was insufficient evidence of declining immunity or of the benefit of boosters in younger people.

The administration of US President Joe Biden announced plans in August to roll out booster doses to all adults in September, before FDA advisers recommended limited authorization.

Reporting by Kanishka Singh in Bengaluru Editing by Chris Reese and Grant McCool

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