The Food and Drug Administration (FDA) on Friday approved the Novavax COVID-19 vaccine, but RFK Jr. is stepping in to limit its avaliability.
The latest Novavax vaccine will only be avaliable to the elderly and those over the age of 12 with an underlying medical condition.
The approval of the vaccine, named Nuvaxovid, is contingent on the company conducting studies to assess potential links to various heart conditions.
However, Some of these investigations can be carried out using existing data sources.
Novavax BLA Approval
Novavax has obtained their Biologics License Application for their COVID-19 vaccine, Nuvaxovid.
This means that they are now allowed to market their COVID vaccine without needing an Emergency Use Authorization any more. pic.twitter.com/SBrMm1JF8n
— Friesein (@Friesein) May 17, 2025
The New York Times has more details:
Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans.
The F.D.A.’s decision appeared to render at least part of their discussion moot.
The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.
The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.
The jab is said to have fewer side effects than mRNA based vaccines because it is built on a more traditional vaccine platform.
Figures in the scientific establishment are already complaining about the restrictrions.
”This is incredibly disappointing,”said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital nd former adviser to the C.D.C.
“I don’t know why they would make this restriction; I don’t know of any indication to make this change,” she continued. “This is a dark day in American medicine.”
The original COVID vaccines, manufactured by major pharmaceutical companies such as Pfizer, Moderna and AstraZeneca, were rife with harmful side effects that ranged from mild myocarditis to fatal reactions.
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