FDA Clears Novavax to Begin Phase 3 Trials for COVID-19-Influenza Combo and Flu Vaccines

• The FDA has lifted the clinical hold on Novavax's COVID-19-Influenza Combination and influenza vaccine candidates, clearing Phase 3 trials.
• The serious adverse event reported during the Phase 2 trial was deemed unrelated to the vaccines, allowing trials to resume.

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Novavax's investigational COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, allowing the company to proceed with a Phase 3 clinical trial. This decision follows a thorough review by the FDA, which concluded that Novavax adequately addressed concerns related to a serious adverse event reported during an earlier Phase 2 trial.

The clinical hold, imposed on October 16, 2024, was triggered by a report of motor neuropathy in a participant who had received the CIC vaccine. However, after additional investigation, the event was reclassified as amyotrophic lateral sclerosis (ALS), a condition not typically associated with vaccination. Novavax’s analysis, supported by the FDA, determined the adverse event was unrelated to the vaccine.

“We thank the FDA for their partnership and thorough review of the additional information provided,” said Dr. Robert Walker, Chief Medical Officer at Novavax.

“The information supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible.”

With the hold lifted, Novavax will now work with clinical trial investigators and partners to quickly resume trial activities. The upcoming Phase 3 study will focus on evaluating the efficacy and safety of both the CIC and stand-alone influenza vaccines.