> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Clinical Hold on Novavax Vaccines Lifted
- URL: https://www.fdaweb.com/clinical-hold-on-novavax-vaccines-lifted/
- Published: 2024-11-11T12:00:00.000Z
- Updated: 2026-09-14T14:46:37.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158155

FDA has lifted a clinical hold on a Novavax IND for its Covid-19-influenza combination (CIC) and stand-alone influenza vaccine candidates. The agency said the company can begin enrolling patients in a planned Phase 3 trial following the determination that it satisfactorily addressed all clinical hold issues, according to Novavax.

The clinical hold [was placed](https://c212.net/c/link/?t=0&l=en&o=4299284-1&h=3227023536&u=https%3A%2F%2Fir.novavax.com%2Fpress-releases%2F2024-10-16-Update-on-Novavaxs-COVID-19-Influenza-Combination-and-Stand-alone-Influenza-Phase-3-Trial&a=announced&ref=fdaweb.com) on 10/16 after the company received a spontaneous report of a serious adverse event in a participant who received the CIC vaccine in a Phase 2 trial that completed in 2023\. FDA had requested additional information on the event, which was reported as motor neuropathy. “The additional information included a change in the event term to amytrophic 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,” Novavax says.