The 2024-2025 formulations for COVID-19 vaccines should uniformly target the JN.1 variant, a US Food and Drug Administration advisory committee said, declining the agency’s invitation to suggest separate variant-based recommendations according to vaccine type.
COVID-19 Vaccines: Novavax Gets Reprieve With US FDA Panel Supporting JN.1 Formulation
Advisory committee members said having Novavax’s protein-based vaccine available in the fall was important, but would not have been possible if a different variant strain were used. They also worried separate recommendations by vaccine type would cause confusion.
More from US FDA Performance Tracker
• By
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.