FDA advises new Covid-19 vaccines targeting JN.1

The US Food and Drug Administration (FDA) convened a crucial meeting on June 5 to address the ongoing challenges posed by Covid-19. The FDA's Center for Biologics Evaluation and Research met with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss updates to the nation's Covid-19 vaccination strategy for the 2024-2025 period. The committee unanimously recommended the development of an updated vaccine targeting the JN.1 variant, a strain derived from BA.2.86 with an additional mutation in its spike protein.

The FDA has previously provided traditional approvals for two Covid-19 vaccines: Moderna's SpikeVax (elasomeran) and Pfizer-BioNTech's Comirnaty (tozinameran). These vaccines are authorized for individuals aged 12 and above to prevent Covid-19 caused by the Sars-Cov-2 virus. In addition, the agency has granted emergency use authorizations for three other vaccines. During the recent meeting, representatives from Moderna, Novavax, and Pfizer-BioNtech presented clinical data showcasing the efficacy of their vaccines against emerging variants, emphasizing the benefits of targeting new strains.

The recommendation by the FDA mirrors similar actions taken by the European Medicines Agency (EMA). After consulting with the World Health Organization (WHO), the EMA decided to include the prevention of the JN.1 strain in the region's Covid-19 vaccines. On April 26, the WHO also advised the global use of a monovalent JN.1 lineage as the antigen in future Covid-19 vaccine formulations, underscoring the international consensus on the importance of targeting this new variant.

Recent data highlight the prevalence of the JN.1 variant. As of January 2024, it accounted for 60% of Covid-19 infections in England, according to UK government reports. In the United States, the Centers for Disease Control and Prevention (CDC) reported in January that JN.1 was responsible for approximately 62% of all circulating Sars-Cov-2 variants. The FDA's advisory committee emphasized that the JN.1 variant had become the predominant strain by the spring of 2024.

This move to update Covid-19 vaccines is driven by the need to maintain their efficacy against evolving strains of the virus. As the JN.1 variant continues to spread, updating the vaccines to target this specific strain will be crucial in controlling the pandemic and preventing future outbreaks. The unified stance of both the FDA and global health authorities, such as the WHO and EMA, highlights the importance of a coordinated effort to combat the ever-changing landscape of Covid-19.

The FDA's decision underscores the ongoing battle against Covid-19 and the necessity for vaccines to evolve in response to new variants. By targeting the JN.1 strain, health authorities aim to ensure that vaccines remain effective and continue to provide robust protection against the virus. This proactive approach is essential in the global fight against Covid-19, as it seeks to address the challenges posed by emerging variants and safeguard public health.