• 04 Sep 2024
• Admin
• News Article

Novavax’s Jn.1-Adapted COVID-19 Vaccine Granted FDA Emergency Use Authorisation

Overview

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.

About JN.1

• 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.

Recent Guidance from the FDA

• 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.

From Center for Biologics Evaluation and Research

• 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.”

Syringes Availability

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.

Words from the CEO: Novavax

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.”

Annual cpmposition review- 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.

Previous Results 

• 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”.