Novavax’s Influenza-COVID Combo Vaccine Trial Halted by FDA Due to Safety Concerns
Neuropathy Reported in Trial Participant
As reported by the National Vaccine Information Center’s , the FDA has halted Novavax’s clinical trials for its COVID-influenza combination vaccine and standalone influenza vaccines following reports of nerve damage in a participant in January 2024.
The condition, diagnosed as motor neuropathy, causes muscle weakness and atrophy. While Novavax denies a direct link to the vaccine, the company is working with the FDA to lift the clinical hold and resume trials. However, this move comes at a time when Novavax’s credibility is under scrutiny, and the pause has significantly impacted its stock, causing a 24% drop and threatening its $1.2 billion partnership with Sanofi to develop a combined vaccine.
This setback is particularly damaging for Novavax, which has faced difficulties maintaining interest in its COVID-19 vaccine. While its protein-based COVID vaccine was introduced as an alternative to mRNA vaccines from Pfizer/BioNTech and Moderna—amid concerns about side effects like heart complications—Novavax’s struggles reveal the limits of its capacity to expand its product portfolio and recover from declining demand.
2024 Flu Shot Ineffectiveness Adds to Novavax’s Challenges
This year’s flu vaccine has shown “disappointing” effectiveness, reducing hospitalization risk by only 34.5%, compared to the usual 50% effectiveness. Data from five South American countries—Argentina, Brazil, Chile, Paraguay, and Uruguay—reflects this trend.
Influenza vaccination rates are down post-pandemic, especially among children and seniors, with only 75.4% of U.S. healthcare workers getting their flu shots in the 2023-2024 season. COVID-19 vaccination rates among healthcare personnel are even lower, with just 31.3% opting for updated shots.
In Canada, influenza vaccination rates among healthcare workers have been reported at around 42.5%. COVID-19 vaccination rates among healthcare workers are also notably low, with recent figures suggesting only about 31% received the most updated booster shots.
*********************************************************************************************************************************