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CSL and self-amplifying mRNA (sa-mRNA) pioneer Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval and authorization for their updated sa-mRNA COVID-19 vaccine, KOSTAIVE®.

According to the September 13, 2024, press release, KOSTAIVE is the world's first commercially available sa-mRNA COVID-19 vaccine for adults 18 and older.

Unlike conventional mRNA vaccines, sa-mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

"We believe KOSTAIVE® has the potential to change the paradigm for COVID-19 vaccines in Japan," commented Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. 

"Today's approval further demonstrates CSL's promise to pursue, develop, and deliver new innovative treatment options to protect public health."

Meiji Seika Pharma, CSL's exclusive partner in Japan, will begin vaccine distribution next month.

Following a peak in July 2024, MHLW data indicates COVID-19 cases in Japan have rapidly declined as of early September.

To avoid diseases such as Japanese encephalitis (IXIARO®), measles, and rubella, the U.S. CDC recommends speaking with a travel vaccine expert at least one month before visiting Japan.

 CSL, including three businesses: CSL Behring, CSL Seqirus, and CSL Vifor, provides lifesaving products to patients in more than 100 countries and employs 32,000 people. 

About two years ago, the World Health Organization (WHO) published a report highlighting the first-ever list of fungal priority pathogens, which included 19 fungi representing the greatest threat to public health.

Since then, the WHO has not recommended a fungal vaccine but continues to encourage the development of innovative therapies.

To address this unmet need, F2G Ltd announced a $100 million financing round that will enable the company to complete late-stage development, seek regulatory approval, and prepare for commercialization in the U.S. of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other invasive fungal infections.

It is anticipated that this treatment will be used to treat patients with a serious invasive, rare fungal disease for which existing treatments are inappropriate or no longer effective.

Olorofim is the first orotomide antifungal, an entirely novel class of antifungal agents. It is the only antifungal medication awarded a Breakthrough Therapy Designation for multiple indications by the U.S. Food and Drug Administration.

Olorofim has a novel mechanism of action, different from that of existing classes of antifungals. It exerts fungicidal activity by inhibiting the pyrimidine synthesis pathway.

Henry Skinner, Ph.D., Chief Executive Officer of AMR Action Fund, commented in a press release on September 12, 2024, “Fungal infections are a growing threat to patients worldwide and have a disproportionate impact on vulnerable populations, yet there has been a paucity of innovation in the field of antifungals."

"For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions. These therapies are increasingly failing in patients."

The U.S. NIH says some fungal infections are more common in people with weakened immune systems or hospitalized individuals, while others can infect anyone, including otherwise healthy people.

As of 2023, fungal vaccine candidates were segmented into broad categories based upon their composition, ranging from multiple to single antigens: whole organism vaccines (live-attenuated or killed fungal cells), crude extracts (fractions derived from cells and medium of fungal cultures), purified subunit vaccines (proteins, peptides), and nucleic acids (RNA and DNA) encoding the antigen(s) of interest.

No fungal vaccine has been approved as of 2024.

Bavarian Nordic A/S today provided an update on its supply and manufacturing activities supporting the ongoing mpox outbreak. The Company produces MVA-BN® (JYNNEOS®, IMVAMUNE®, and IMVANEX®), a leading smallpox and mpox vaccine.

Since the recent declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), Bavarian Nordic has intensified the collaboration with global stakeholders to support efforts to combat the mpox outbreak.

Thanks to donations from the European Commission, the U.S. government and Bavarian Nordic, the first doses of MVA-BN arrived last week in the Democratic Republic of Congo, the epicenter of the mpox clade 1b outbreak. More than 250,000 doses have already been shipped, and other countries have pledged further donations of more than 500,000 doses of MVA-BN.

Bavarian Nordic stated that by focusing the full capacity to address the current public health emergency, the Company could supply up to 13 million MVA-BN doses by the end of 2025, including 2 million in 2024.

Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on September 12, 2024, “As the supplier of the only non-replicating mpox vaccine that has shown to be highly effective during a mpox outbreak, we have been working closely with all governments and organizations to support the international efforts to combat the latest public health emergency."

"Just as during the clade two mpox outbreak in 2022/23, we will support all requests for vaccine and have already secured agreements and submitted responses to the UNICEF tender that will hopefully secure more access to MVA-BN globally."

The JYNNEOS vaccine is commercially available in the United States at select travel clinics and pharmacies. 

The U.S. government recommends two JYNNEOS doses to provide robust protection against disease. However, routine immunization against mpox is not recommended for the general public, and a booster dose (3rd) is not endorsed.