Novavax Inc. (NVAX) stock took a significant hit on Wednesday, plummeting in pre-market trading after the Food and Drug Administration (FDA) placed a clinical hold on the company’s Investigational New Drug (IND) application for its combined COVID-19 and influenza vaccine candidate. The decision came in response to a single reported case of motor neuropathy, a condition affecting nerve function, in a participant outside the U.S. who received the vaccine during a Phase 2 trial in January 2023. This trial, completed in July 2023, saw the participant report the adverse event in September 2024.
The FDA’s action immediately halted further development of this promising combination vaccine, designed to offer protection against both COVID-19 and the flu in a single shot. Novavax, in a statement, emphasized its commitment to working closely with the FDA to provide the necessary information to address the agency’s concerns and lift the clinical hold. They also stressed that previous trials of their COVID-19 and influenza vaccines have not shown any signs of motor neuropathy.
While this setback comes as a blow to Novavax, it’s crucial to note that the clinical hold specifically pertains to the combined COVID-19/influenza vaccine candidate. The IND application for Novavax’s standalone COVID-19 vaccine remains unaffected.
This development comes on the heels of positive news for Novavax. In April 2022, the company announced initial results from the Phase 1/2 trial of its combined vaccine, indicating promising immune responses comparable to standalone COVID-19 and influenza vaccines. The initial trial also suggested the combination vaccine was well-tolerated with few serious adverse events, none of which were deemed related to the vaccine. Additionally, last week, the European Commission approved Novavax’s updated 2024-2025 Nuvaxovid COVID-19 vaccine for use in individuals aged 12 and older across the European Union.
The FDA’s clinical hold, however, raises concerns about the safety profile of the combined vaccine. While the single case of motor neuropathy is concerning, it’s important to emphasize that this is an isolated incident and does not necessarily indicate a widespread safety issue. Novavax will need to provide compelling data to the FDA to address their concerns and demonstrate the safety of their combined vaccine candidate. The outcome of this process will undoubtedly have a significant impact on Novavax’s future prospects.