Dr. Vinay Prasad, the U.S. Food and Drug Administration’s (FDA) top vaccine official, overruled agency scientists to limit approval of two COVID-19 vaccines, despite internal recommendations to clear them for broader use.
The decision reflects a growing pattern of vaccine restrictions under the leadership of the U.S. Health and Human Services Secretary Robert F. Kennedy Jr.
FDA scientists had recommended full approval for updated COVID vaccines from Novavax Inc. NVAX and Moderna Inc. MRNA for individuals aged 12 and older, citing favorable risk-benefit analyses.
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However, citing federal documents released Wednesday, ABC News reported that Prasad restricted the shots to those at higher risk, seniors and people with underlying health conditions, arguing that declining hospitalization and death rates from COVID-19 shifted the balance of risks and benefits.
In a five-page memo, Prasad wrote that “even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits,” highlighting the need for more cautious vaccine policy.
The vaccines were eventually approved in May, but under the narrower eligibility criteria dictated by Prasad.
Novavax’s shot, Nuvaxovid, is the only protein-based COVID vaccine available in the U.S., while Moderna’s mNexspike is a lower-dose, updated version of its original mRNA-based vaccine.
Prasad also cited the risk of myocarditis, a rare heart inflammation, especially in younger people, as a key reason for restricting Moderna’s shot.
He directed the company to conduct further studies as a condition for approval. The FDA also added updated warning labels for Moderna and Pfizer Inc.’s PFE vaccines regarding myocarditis, though external researchers say such cases are typically mild and resolve quickly.
Top FDA leaders rarely intervene in the product review, making Prasad’s decision notable. He was appointed in May after Dr. Peter Marks resigned over policy disagreements with Kennedy.
In May, Kennedy, in a video posted to the social media platform X, announced that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the U.S. Centers for Disease Control and Prevention’s immunization schedule.
Price Action: At the last check on Thursday, Moderna (MRNA) stock saw an increase of 1.34%, trading at $30.69, while Novavax (NVAX) stock rose by 0.67% to $6.81. Pfizer (PFE) stock was also up at the last check.
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