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The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 ... represents an important ...
The surprise delay is casting new uncertainty on the fate of another vaccine awaiting FDA action: Moderna’s next-generation ...
The delay follows leadership changes within the FDA. Dr. Scott Steele has been appointed acting director of the agency’s ...
The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...
The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...
The agency is sitting on a decision to grant full approval for Novavax’s shot, days after top vaccine regulator pushed out.
The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal ...
The company has also filed for FDA approval of its flu+Covid combination vaccine, mRNA-1083. If approved, it will be the first in the US to offer protection against flu and Covid-19 in a single shot.
But with FDA action, it would be the third vaccine against COVID-19 to receive full FDA approval. Full approval would make the vaccine available beyond an emergency declaration and could provide ...