Japan greenlights updated Covid-19 vaccine for JN.1 variant

CSL and Arcturus Therapeutics have announced the approval of their self-amplifying mRNA (sa-mRNA) vaccine, Kostaive (ARCT-154), in Japan. This vaccine is designed to combat the JN.1 strain of Covid-19 and has received authorization from Japan’s Ministry of Health, Labour, and Welfare (MHLW). Distribution will be managed by Meiji Seika Pharma as part of the October 2024 Covid-19 vaccination campaign, according to CSL’s Senior Vice President and Head of Global Regulatory Affairs, Emmanuelle Lecomte-Brisset.

Lecomte-Brisset expressed enthusiasm about the introduction of Kostaive in Japan, emphasizing its safety, tolerability, and potential for long-lasting protection against Covid-19. The JN.1 strain, a derivative of the Omicron variant BA.2.86, is marked by an additional mutation in the spike protein.

Kostaive stands out from other mRNA vaccines like Pfizer and BioNTech’s Comirnaty and Moderna’s Spikevax. Unlike these vaccines, Kostaive is a self-amplifying mRNA vaccine, meaning it instructs the body to produce more mRNA and protein, thereby inducing a stronger immune response.

This approval follows recommendations from a Japanese health ministry panel in May, suggesting that Covid-19 vaccines should be updated to protect against current subvariants of Omicron. These decisions are in line with the World Health Organization’s (WHO) recommendations on updating vaccines.

In a similar vein, Japan’s MHLW approved an updated formulation of Moderna’s Spikevax targeting the JN.1 variant in August. Meanwhile, the US Food and Drug Administration (FDA) also addressed the need for updated Covid-19 vaccines. On June 5, the FDA’s Center for Biologics Evaluation and Research (CDER) convened a meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss updates to the US Covid-19 vaccines for 2024 to 2025. The committee unanimously decided to update vaccines to target the JN.1 variant. Following this decision, the FDA granted approval for updated versions of Comirnaty and Spikevax in late August. 

In summary, the approval of Kostaive in Japan signifies a notable advancement in Covid-19 vaccine technology. Designed as a self-amplifying mRNA vaccine, it promises a more robust immune response and extends the options available for combating the evolving virus.

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