Novavax: FDA lifts clinical hold

(CercleFinance.com) - Novavax announces that the U.
S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its COVID-19 combination influenza (CIC) and influenza-only vaccines.

The FDA has authorized the company to begin enrollment in the Phase 3 trial, deeming that Novavax has resolved all issues related to the clinical suspension.

Novavax will work with the clinical trial investigators and other partners to resume trial activities as soon as possible.

As a reminder, the clinical suspension, announced on October 16, 2024, followed a spontaneous report of a serious adverse event in a participant who had received the investigational CIC vaccine in a Phase 2 trial completed in 2023, after the adverse event was assessed as unrelated to vaccination.

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