USFDA removes clinical hold on Novavax COVID Influenza combination, stand alone Influenza Phase 3 trial

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-11-12 05:30 GMT   |   Update On 2024-11-12 05:30 GMT
Advertisement

Gaithersburg: Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M adjuvant, has announced that the U.S. Food and Drug Administration (USFDA) has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) 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.

Advertisement

"Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible," the Company stated.

"We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package," said Robert Walker, MD, Chief Medical Officer, Novavax. "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."

Read also: FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

The clinical hold announced on October 16, 2024, resulted from a spontaneous report of a serious adverse event in a participant who received investigational CIC vaccine in a Phase 2 trial that 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 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, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio includes its COVID-19 vaccine and its pipeline includes its CIC and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. 

Read also: EU gives marketing authorization for Novavax updated 2024-2025 Nuvaxovid COVID vaccine

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News