After delaying the approval of its COVID-19 vaccine, the U.S. Food and Drug Administration (FDA) recently declared that Novavax must finish more clinical trials of the vaccine.
The FDA declared that more research was required to demonstrate the vaccine’s effectiveness after the designee of Health and Human Services Secretary Robert F. Kennedy Jr. interfered with the vaccine’s approval process.
In April, the FDA postponed approving Novavax’s COVID-19 vaccine, stating that it required additional data before granting full approval.
In response to the FDA’s request for a post-marketing commitment, Novavax stated that the agency’s response is pending. They expressed confidence in their ability to demonstrate the vaccine’s effectiveness and hope for immediate FDA approval.
Novavax’s protein-based vaccine development technology is expected to be an alternative to Pfizer and Moderna’s mRNA vaccines.
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