The agency overrules Vinay Prasad’s refusal to consider Moderna’s shot.
Is the White House putting a leash on Food and Drug Administration vaccine chief Vinay Prasad? Americans can hope so after the agency on Wednesday walked back Dr. Prasad’s startling summary refusal last week to review Moderna’s new flu vaccine.
The FDA rarely refuses to consider an application for a new drug or vaccine, but that’s what Dr. Prasad did last week in a move that shocked the industry. He said Moderna’s late-stage trial wasn’t “adequate and well-controlled” because the control arm did not reflect the “best-available standard of care,” which he deemed a high-dose flu vaccine.
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