by WorldTribune Staff, October 17, 2024 Contract With Our Readers

The FDA has stopped the trial of Novavax’s experimental Covid-flu combination vaccine and its standalone flu shot after a trial participant reported nerve damage.

The participant developed motor neuropathy — a disease affecting the nerves that control muscles after receiving the Covid-flu combination shot in January 2023 during Phase 2 trials for the drug. However, Novavax said it didn’t receive the report on the adverse reaction until last month.

In response, the FDA put a clinical hold on Novavax’s Covid-flu Phase 3 trial, which was set to begin this month, and on its flu vaccine trials, The Defender reported on Oct. 16.

Novavax’s only commercial product, the protein-based Covid vaccine, does not have a significant market share relative to the Pfizer and Moderna mRNA shots, Reuters reported.

As of Aug. 17, 2022, only 11,990 doses of the Novavax Covid vaccine had been administered in the U.S. And between July 13, 2022, and March 13, 2023, only 69,227 Novavax doses were administered.

There have been 545 adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) associated with the Novavax Covid injection. 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 in the Novavax Covid-flu combination trial — 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,” The Defender noted.

“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. “With industry money flowing freely at FDA through programs like Fast Track, this type of move is not surprising. Unfortunately, it puts the patient-consumers in the direct line-of-fire of faulty products that are inappropriately approved based on corporate pressure and not safety.”

Novavax’s share price immediately plummeted about 20% in early trading after the trial was halted. The company is struggling financially, FierceBiotech reported, having begun 2024 with a second round of layoffs that reduced its workforce by around 30%. Its growth plans are largely based on these two vaccines.

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  FDA halts Novavax trial of Covid-flu combination jab after participant develops nerve damage, WorldTribune.com