The U.S. Food and Drug Administration (FDA) has paused Novavax’s application for a COVID-flu combination shot after a single report of nerve damage in a trial participant.

The FDA also put a hold on the company’s application for a stand-alone flu vaccine.

“The so-called clinical hold is due to a single report of nerve damage in a patient who received the combination shot in a phase two trial that finished in July last year,” CNBC reports.

However, the FDA has turned a blind eye to deaths and injuries caused by mRNA shots.

“FDA Pauses Novavax COVID-Flu Shot Trial Due to Single Case of Nerve Damage While Completely Ignoring 37,900 Deaths Reported to VAERS,” McCullough Foundation wrote.

“Since when has the FDA shown such concern for the safety of injectable products? This move seems poised to undermine Novavax in favor of mRNA-producing brands like Pfizer and Moderna,” it added.

“Just like J&J. Pave the way for mRNA,” Dr. Mary Talley Bowden commented.

CNBC reports:

A clinical hold is an order issued by the FDA to a manufacturer to delay or suspend a proposed clinical investigation on a drug.

It is unclear if the pause will impact Novavax’s ability to start and release data on phase three trials on those vaccines. Still, it appears to be a setback for the biotech company, which is scrambling to bring new products to market as demand for its Covid vaccine plummets worldwide.

Novavax said it was working with the FDA to resolve the clinical hold on its combination shot and stand-alone flu vaccine. The company said other trials of its Covid and flu shots had not shown any safety concerns related to the type of nerve damage reported in the patient.

Novavax said it does not believe there’s an established connection that the vaccine had caused the nerve damage in the patient, but said it is working to provide more information to the FDA.

“Data from Novavax’s previous COVID-19 and influenza trials have shown no signals for motor neuropathy,” Novavax stated in a press release.

“We are working closely with the FDA 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, Novavax.

“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 fulfill requests for more information from the FDA. Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible,” he added.

According to The Defender, the FDA has allowed trials of other drugs that showed serious adverse events to continue and granted them approval. 

“Although I’m glad the trial was suspended, I strongly believe the FDA should explain why some trials are given a pass for serious adverse events, including death, and others are not,” Brian Hooker, Ph.D., chief scientist for Children’s Health Defense told The Defender. 

From The Defender:

There have been 545 adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) associated with the Novavax COVID-19 vaccine. They include serious adverse events such as Guillan-Barré syndrome — a rare disorder in which the body’s immune system attacks its nerves — thrombosis, pericarditis and seizures.

Dr. Meryl Nass, an internist, told The Defender there have been other recent drug trials in which participants suffered serious adverse events similar to the one reported by Novavax today — yet the trials were allowed to continue, and the drugs were approved.

For example, in the adult RSV trials for Pfizer’s Abrysvo, two participants were diagnosed with Guillain-Barré syndrome. In GSK’s Arexvy vaccine trial, there was one reported case of Guillain-Barré and one death, both of which the FDA found to be potentially linked to the vaccine.

In May 2023, the FDA approved Abrysvo for adults over 60, and in June 2023, the agency approved Arexvy for the same population.

The Centers for Disease Control and Prevention narrowed the recommended age group for the drug to adults over 75 in June 2024, citing growing evidence of adverse events associated with the RSV vaccine. Consistent with evidence from clinical trials, those adverse events included the documented risk of Guillain-Barré syndrome.

 

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