U.S. FDA Pauses Clinical Trial of COVID-19 Flu Vaccine; Novavax (NVAX.US) Shares Dip Nearly 30% Pre-Market

Zhitong Finance APP noticed that Novavax (NVAX.US) shares fell nearly 30% before the US market opened on Wednesday after the FDA suspended its new drug application for its COVID-19 and flu combined vaccine and its stand-alone flu candidate vaccine due to a serious adverse event in a trial participant. As of the writing, Novavax fell 16.83% to $10.61.

The FDA said: "The clinical hold was due to a serious case of peripheral neuropathy reported spontaneously by a participant in the CIC Phase 2 trial outside the United States who received the vaccine in January 2023.

The trial was completed in July 2023, and the adverse event occurred in September 2024.

Novavax's chief medical officer Robert Walker said: "We are working closely with the FDA to provide the necessary information to better understand this observation and address the clinical issue."

The company said that the previous COVID-19 and flu trials did not show signs of peripheral neuropathy, and the clinical hold would not affect its new drug application for its independent COVID-19 vaccine.