Novavax will move forward with its planned phase 3 trial for the COVID-19-influenza combination vaccine after the FDA determined that a reported serious adverse event was unrelated to the vaccine.
RT’s Three Key Takeaways:
- FDA Clears Novavax to Resume Vaccine Trial: The FDA removed the clinical hold on Novavax’s COVID-19-influenza combination vaccine—as well as its stand-along flu vaccine—allowing the company to proceed with its planned phase 3 trial.
- Adverse Event Assessed as Unrelated to Vaccine: The clinical hold was initially placed due to a serious adverse event reported as motor neuropathy, later revised to amyotrophic lateral sclerosis (ALS), which the FDA concluded was not linked to the vaccine.
- Trial to Restart Immediately: With the FDA’s green light, Novavax plans to work with trial investigators to resume enrollment and continue developing its COVID-19-influenza combination and stand-alone flu vaccines.
Novavax Inc, a company advancing protein-based vaccines with its Matrix-M adjuvant, announced that the US Food and Drug Administration (FDA) has removed the clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-influenza combination and stand-alone influenza vaccine candidates.
The FDA has cleared the company to begin enrolling the planned phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible, according to a release from the company.
“We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package,” says Robert Walker, MD, chief medical officer of Novavax, in a release. “The information provided to the FDA 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.”
Reason for the Clinical Hold
The clinical hold resulted from a spontaneous report of a serious adverse event in a participant who received an investigational COVID-19-influenza combination vaccine in a phase 2 trial that was completed in 2023. The FDA had requested additional information on this event, initially reported as motor neuropathy.
The additional information included a change in the event term to amyotrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination.
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