Novavax’s JN.1-adapted COVID-19 vaccine has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for use in individuals aged 12 years and older.
The announcement comes just over a week after the regulator approved updated vaccines from Pfizer/BioNTech and Moderna that target the KP.2 strain, a descendant of JN.1.
JN.1 only accounts for 0.2% of cases across the country, according to the latest Centers for Disease Control and Prevention data, but is the ‘parent strain’ of currently circulating variants.
The adaptations are based on recent guidance from the FDA, which advised COVID-19 vaccine manufacturers in June that vaccines for 2024/2025 should target JN.1, particularly KP.2 “if feasible”.
Its latest authorisation was supported by non-clinical data that showed Novavax’s updated vaccine provides cross-reactivity against JN.1 and multiple JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible.
“[This] authorisation provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support EUA.”
Pre-filled syringes of the vaccine will be available in thousands of locations following the Center for Biologics Evaluation and Research’s release of vaccine batches, Novavax said.
The company’s president and chief executive officer, John Jacobs, said: “[This] authorisation enables Novavax to launch our updated COVID-19 vaccine in the US in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide.”
The FDA has previously outlined that it anticipates that the composition of COVID-19 vaccines will need to be evaluated annually, as occurs for seasonal influenza vaccines.
Pfizer/BioNTech and Moderna have been developing combination vaccines for flu and COVID-19.
Top-line results from a late-stage study of Pfizer and BioNTech’s candidate were announced last month. Moderna also recently shared positive phase 3 results for its own flu/COVID-19 combination vaccine candidate and said it will “engage with regulators on next steps”.