The U.S. Food and Drug Administration said on Tuesday it would review Pfizer Inc’s (PFE.N) request to authorize Booster doses of COVID-19 vaccine in all adults as expeditiously as possible, with the New York Times reporting that the regulatory nod could come as soon as Thursday.
The agency said it does not plan to hold a meeting of the outside experts on Pfizer’s request, concluding the request does not raise questions that would benefit from additional discussion by the members of the committee.
The decision from the FDA will likely come before a U.S. Centers for Disease Control and Prevention (CDC) advisory panel meets on Friday to discuss expanding the eligibility for Booster doses of Pfizer/BioNTech’s vaccine, currently allowed for select groups of people. Earlier this month, Pfizer had requested the FDA to authorize Booster doses of the vaccine in all adults, presenting recent data showing the shot would help prevent disease across ages.
The company’s third dose has been authorized for immunocompromised individuals, people aged 65 and above, all those at high risk of severe disease, and people who are regularly exposed to the virus. U.S. President Joe Biden’s administration in August announced plans to roll out Booster doses for all adults in September.The U.S. Centers for Disease Control and Prevention sets U.S. adult and childhood immunization schedules based on recommendations from the Advisory Committee on Immunization Practices.