The FDA has placed a clinical hold on Novavax’s investigational new drug (IND) applications for its combined COVID-19/influenza vaccine and standalone influenza vaccine candidates. The move comes after participants who received the combination vaccine reported experiencing motor neuropathy, a rare acquired immune-mediated disease that causes muscle weakness in the arms and legs. . As a result of the FDA’s clinical hold, Novavax stock has fallen significantly. Approximately 16%.3
Participants received the vaccine in January 2023, the trial was completed in July 2023, and serious adverse events (SAEs) were reported by participants in September 2024. It is currently the company’s only product available on the U.S. market that is not affected by the FDA’s clinical hold. 2
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According to a news release, the SAE occurred in a Phase 2 trial participant who was outside the United States. The trial reached competition in June 2023, and a Phase 3 trial was in development between Novavax and the FDA at the time the SAE was reported. Additionally, Novavax emphasized that the AEs were not related to other vaccine candidates under investigation and there were no other cases of motor neuropathy during the Phase 2 trial or during previous trials. Additionally, cases of this AE have been previously reported by some individuals who received other COVID-19 vaccines. However, this complication is not directly related to vaccination. 3
Novavax is confident that its current adjuvanted COVID-19 vaccine (2024-2025 formulation) will improve the efficacy of the original monovalent Novavax COVID-19 vaccine and that of Omicron BA.1 and Omicron BA.5.3. reported that it is based on the immunogenicity of monovalent vaccines. The 19 vaccines are built on protein-based platforms used in some vaccines for influenza, respiratory syncytial virus, and hepatitis B, and serve as an alternative to mRNA vaccines. 2,4
“We are working closely with the FDA to provide the necessary information to help them better understand this finding and resolve the clinical hold,” said Robert Walker, M.D., Novavax’s chief medical officer. said in a news release. “It is important to note that safety is our top priority, and although we do not believe a causal relationship with this SAE has been established, we remain responsive to requests for further information from the FDA.” Our goal is to successfully resolve this issue and begin Phase 3 trials as soon as possible. ”
Additionally, even if you have been previously vaccinated, it is still important that you are up to date with your vaccinations. In an interview with Pharmacy Times, Walker said that while previous vaccines may provide some level of protection, it is best to receive the latest formulations containing currently circulating strains for optimal protection against infection. He emphasized that there is. 5
Walker said the decline in vaccination rates is likely due to general vaccine hesitancy and inadequate or inaccurate information that can be circulated. He also acknowledged that some people may be tired of getting vaccinated every year and want to move on from the COVID-19 pandemic.
“…Our job, of course, is to help people understand the importance of getting vaccinated and to try to raise awareness as much as possible because vaccination is in the best interest of the individual. It’s also important for other family members to not spread the virus to their loved ones. We also want to make sure that people who are susceptible to the really bad kinds of illnesses can end up getting seriously ill. It’s also important for the community to be on a ventilator in a hospital or intensive care unit,” Walker explained during an interview. “We want to ensure that vulnerable people in our communities are protected, and the best way to do that is to protect ourselves and reduce the opportunity for the virus to spread.” 5
References
1. Reuters. The US FDA has suspended clinical trials of Novavax’s new coronavirus combination vaccine due to safety concerns. News release. October 16, 2024. Accessed October 17, 2024. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-places-trials-two-novavax-vaccines-hold-2024-10-16/2. PR Newswire. Update on Novavax’s Phase 3 study in combination therapy for COVID-19 and influenza and influenza alone. News release. October 16, 2024. Accessed October 17, 2024. https://www.prnewswire.com/news-releases/update-on-novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-phase-3 -trial-302277807.html3. biospace. Novavax’s stock price fell after the FDA paused development of its coronavirus/influenza vaccine candidate. News release. October 16, 2024. Accessed October 17, 2024. https://www.biospace.com/drug-development/novavax-shares-slide-as-fda-pauses-covid-flu-vaccine-candidates4. Non-mrna COVID-19 vaccine information for HCPs: Novavax COVID-19 vaccine, adjuvanted (2024-2025 formulation). Non-mRNA COVID-19 Vaccine Information for HCPs | Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formulation). Accessed October 17, 2024. https://us-hcp.novavaxcovidvaccine.com/5. New coronavirus vaccine targeting new variants for the 2024-2025 season. Pharmacy Times. September 2, 2024. Accessed October 17, 2024. https://www.pharmacytimes.com/view/covid-19-vaccines-targeting-new-variants-for-2024-2025-season
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