US EditionFDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
- The FDA delayed granting full approval for Novavax's COVID-19 vaccine despite earlier progress.
- The agency is seeking more data before making a final decision on the application.
- Novavax stated it had addressed all FDA requests with Phase 3 trial data showing safety and effectiveness.
- According to Novavax, "As of Tuesday, April 1, we had responded to all of the FDAs information requests."
- Full FDA approval would expand vaccine availability and reassure the public, but delays are due to ongoing review.
33 Articles
33 Articles
FDA Deadline for Novavax’s COVID-19 Vaccine Passes Without Decision
The Food and Drug Administration (FDA) missed a deadline for Novavax’s COVID-19 vaccine, just days after the agency’s top vaccine official announced his resignation. The FDA was supposed to decide on Novavax’s application for a license for its COVID-19 shot by April 2, the Maryland-based company said in a statement. Novavax said that as of April 1, it had responded to all of the FDA’s requests for information and believed its Biologics License A…
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on track to be cleared until Tuesday afternoon, a person familiar with the situation told CNN.
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