FDA Committee Unanimously Votes to Update Covid-19 Vaccine for Fall

The US Food and Drug Administration's (FDA) committee of independent advisers has unanimously voted to recommend that the agency instruct vaccine manufacturers to update Covid-19 vaccines to be more effective against the JN.1 lineage of the coronavirus. The vote was held on the question of whether to roll out a monovalent JN.1-lineage vaccine composition for the 2024-2025 formula of COVID-19 vaccines in the US. All 16 advisers voted 'yes'. The FDA is yet to make a final decision but if it agrees with the advisory committee's recommendation, it will result in a new shot that protects against one coronavirus variant. Previous vaccines have been bivalent, offering protection against two variants, but JN.1 and its descendants KP.2 and KP.3 are the versions most common in the US currently, according to the US Centers for Disease Control and Prevention.

Recent vaccination data shows that only 25% of adults have received the latest shot, with 3-4% of those getting tested for the virus testing positive. However, Dr. Natalie Thornburg, acting chief of the Laboratory Branch of the Coronavirus and Other Respiratory Viruses Division of the National Center for Immunization and Respiratory Diseases at the CDC, has stated that hospitalization and death rates are currently the lowest since March 2020. She attributed this to vaccination and previous infection with the virus.

The vaccine manufacturers Pfizer/BioNTech, Moderna, and Novavax have assured the committee that they have already started working on the updated vaccine and it would be safe and effective. They also mentioned that they could have doses available by August 2023.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told the committee that the FDA will carefully consider the recommendations as it makes its final decision.