FDA, Novavax and Covid-19
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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.
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.
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.
Moderna (MRNA), and Novavax (NVAX) agree as the FDA advisors recommend targeting JN.1 strain for updated COVID vaccines this fall. Read more here.
WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.