Summarised by Centrist
The US Food and Drug Administration’s (FDA) emergency authorisation of a new COVID protein-based vaccine from Novavax was granted without requiring clinical data.
Instead, animal testing data was deemed sufficient for authorisation. Some critics, however, aren’t entirely convinced.
Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated that the vaccine meets safety, effectiveness, and manufacturing standards. Yet, critics like Barbara Loe Fisher, president of the National Vaccine Information Center, argue that these claims “ring hollow” without clinical trial data.
Novavax’s President, John C. Jacobs, said their vaccine worked well against JN.1 viruses in animals, but the US CDC pointed out that newer versions, like KP.3, have now replaced JN.1.
The authorisation covers individuals aged 12 and older, with the option for two doses for those previously unvaccinated and one dose for those who have already received a COVID vaccine. Despite the ongoing debate, the CDC continues to recommend COVID vaccination for all people aged six months and older.
