CSL and Arcturus Therapeutics’s self-amplifying mRNA (sa-mRNA) vaccine, Kostaive (ARCT-154) has been approved in Japan to tackle the JN.1 strain of Covid-19.
The vaccine was approved by Japan’s Ministry of Health, Labour, and Welfare (MHLW) and Meiji Seika Pharma will be responsible for distribution as part of the October 2024 Covid-19 vaccination campaign, said CSL’s SVP and Head of Global Regulatory Affairs, Emmanuelle Lecomte-Brisset.
“We look forward to introducing Kostaive in Japan as a safe, tolerable and more durable option in protecting against Covid-19,” Lecomte-Brisset added in the 13 September announcement.
JN.1 is a derivative of Omicron variant BA.2.86 and is characterised by an extra mutation in the spike protein.
Like Pfizer and BioNTech’s Comirnaty and Moderna’s Spikevax, Kostaive is an mRNA vaccine designed to protect against Covid-19 by providing the body instructions on how to fight the disease. However, the sa-mRNA vaccine, Kostaive instructs the body to produce more mRNA and protein, promoting a stronger immune response.
According to GlobalData’s consensus forecasts, Kostaive is expected to generate total sales of $697m in 2030. GlobalData is the parent company of Pharmaceutical Technology.
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By GlobalData
With its November 2023 approval in Japan, Kostaive became the first sa-mRNA Covid-19 vaccine to gain approval. The vaccine is intended for use in adults 18 years and older.
The updated approval of Kostaive comes after a Japanese health ministry panel recommended in May that Covid-19 vaccines be updated to protect against the present subvariants of Omicron. The decisions also aligned with the World Health Organization’s (WHO) stance on updated vaccines.
In August, Japan’s MHLW granted Moderna approval for an updated formulation of Spikevax targeting JN.1.
Similar to Japan’s MHLW, on 5 June, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CDER) held a meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the changes to implement to the US Covid-19 vaccines from 2024 to 2025. The committee was unanimous in their decision to update vaccines to target the JN.1 variant.
Following the decision, the FDA granted updated versions of Comirnaty and Spikevax approval in late August.
