HQ Team
November 12, 2024: Novovax Inc., will soon start enrollment for end-stage trials of its Covid-19-Influenza vaccine and stand-alone influenza jab following a nod from the US drug regulator.
The Food and Drug Administration withdrew a clinical hold on the investigational drug application for the protein-based vaccines, according to a company statement.
The FDA cleared the company to start enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues, according to the statement.
Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.
‘Serious event not related to vaccine’
“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.”
The clinical hold announced on October 16, 2024, resulted from a spontaneous report of a serious adverse event in a participant who received an investigational vaccine in a mid-stage 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.
Protein-based vaccine
The protein-based vaccine is made by creating copies of the surface spike protein of SARS-CoV-2 that causes Covid-19. The non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus.
The Covid-19 vaccine of Novavax is the company’s sole product in the market and amid falling global vaccine sales analysts have questioned the very survival of the Gaithersburg, Maryland-based firm.
In May, Novavax signed a $1.2 billion licensing agreement with Sanofi that included commercialising a combination Covid-19 flu shot as it hoped to turn the corner.
The FDA cleared Novavax’s Covid-19 vaccine, targeting the JN.1 strain, for people 12 years of age and older, in August 2024.
