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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 delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...
Kennedy Jr., and that the deputy commissioner at the FDA intervened in the ... which is contingent on the approval. But Sanofi can still go ahead with the vaccine rollout on the basis of the ...
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.
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 ...
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 ...
The delay dovetails with moves by Republican lawmakers in at least 7 states to ban or limit mRNA vaccines. HealthDay News — The US Food and Drug Administration (FDA) has delayed the full ...