FDA plans to limit COVID vaccine to only high-risk people
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The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.
Covid shots are facing greater scrutiny from top federal health officials like RFK Jr. and the FDA's Marty Makary.
While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the company.
This vaccine did previously have emergency approval by the FDA for use but can now be marketed in the U.S. for use, the letter said.
Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.
The US Food and Drug Administration changes Covid-19 vaccine approval process. Access to seasonal boosters is restricted for healthy individuals under 65. This decision contrasts with previous recommendations for annual shots for all.
JPMorgan analyst Eric Joseph reaffirmed an Underweight rating for Novavax Inc. (NASDAQ:NVAX) with a price target of $7. This comes after the Food and Drug Administration (FDA) approved the company’s COVID-19 vaccine,