HQ Team
October 17, 2024: Novavax, Inc.’s mid-stage trials on a combination of Covid-19 and influenza and a standalone influenza vaccine have been put on hold by the US regulator after a volunteer developed a serious nerve disorder.
“The clinical hold is due to a spontaneous report of a serious adverse event of motor neuropathy in a single,” participant outside of the US, who received the combination vaccine in January 2023, Novavax stated.
The trial was completed in July 2023 and the participant reported the serious adverse event in September 2024, according to the statement.
“We are working closely with the Food and Drug Administration to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold,” said Robert Walker, MD, Chief Medical Officer of Novavax.
‘Aim to start end-stage trial’
“It is important to note that safety is our top priority, and while we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfil requests for more information from the Food and Drug Administration.
“Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible,” Walker said.
Data from Novavax’s previous COVID-19 and influenza trials have shown no signals for motor neuropathy. Investigators have been informed of this action, he said.
The company stated that Covid-19 IND for Novavax’s COVID-19 vaccine is not impacted by the clinical hold.
August clearance
The US Food and Drug Administration cleared Novavax’s Covid-19 vaccine, targeting the JN.1 strain, for people 12 years of age and older, in August 2024.
The emergency use of the shot includes “a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.” The virus has claimed the lives of more than seven million people globally.
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.
Sole product
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 agreement allowed the French drugmaker to use Novavax’s Covid-19 vaccine to develop the shot along with Sanofi’s flu jab.
