(Reuters) -The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 vaccine recommendations for the upcoming immunization campaign. The meeting comes after the appointment of Martin Makary as FDA commissioner. Makary had earlier raised concerns about a number of public health efforts during […]
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US FDA advisers to discuss COVID-19 vaccine recommendations on May 22
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(Reuters) -The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 vaccine recommendations for the upcoming immunization campaign.
The meeting comes after the appointment of Martin Makary as FDA commissioner. Makary had earlier raised concerns about a number of public health efforts during the COVID-19 pandemic, touted the protection received from natural immunity and opposed vaccine mandates for the general public.
In the U.S., three COVID shots have been authorized for use – Moderna and Pfizer-BioNTech’s/ messenger RNA based vaccines along with Novavax’s protein-based shot.
Federal regulators had asked Novavax to complete an additional clinical trial on its vaccine after previously delaying approval beyond the agency’s April 1 deadline, the Wall Street Journal had reported last month.
Health secretary Robert F. Kennedy Jr had attributed the delay to the shot’s composition.
Novavax is looking to convert its vaccine’s emergency authorization into a full approval, which would allow it to compete better against shots from Pfizer-BioNTech and Moderna, which received full approvals in 2021 and 2022, respectively.
Meanwhile, mass layoffs at the FDA as part of a major overhaul under Kennedy has prompted worries about potential disruptions to the regulatory review of treatments and vaccines.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shinjini Ganguli and Leroy Leo)