Bavarian Nordic Receives Mpox Vaccine Green Light From Singapore

Bavarian Nordic announced today that its vaccine, JYNNEOS, has been licensed by Singapore’s Health Sciences Authority (HSA) for the prevention of smallpox and mpox in individuals aged 18 and older who are at increased risk of infection. This approval marks a transition to full licensure for JYNNEOS in Singapore, where, like in many other countries, the vaccine was previously available under emergency use authorization to combat the recent mpox outbreak.

Paul Chaplin, CEO of Bavarian Nordic, emphasized that the World Health Organization’s (WHO) recent declaration of mpox as a Public Health Emergency of International Concern (PHEIC) highlights the critical need to remove barriers to vaccine access globally. He expressed satisfaction in adding Singapore to the growing list of countries where their smallpox and mpox vaccines are now fully authorized.

Chaplin also mentioned that the company is working with regulators in other countries to further expand vaccine access. Additionally, they are actively supporting the WHO Emergency Use Listing process and collaborating with the Africa CDC to ensure the vaccine is available on the African continent, where preventive measures are urgently needed.

Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) is the only non-replicating mpox vaccine authorized in Singapore, the U.S., Switzerland, Canada, the European Union/EEA, and the U.K.

Originally developed in partnership with the U.S. government to ensure that all Americans, including those with compromised immune systems, have access to a smallpox vaccine, MVA-BN is now approved for use in adults at risk of contracting smallpox or mpox.

Based on findings from a clinical study funded by the U.S. National Institutes of Health (NIH), Bavarian Nordic has requested the European Medicines Agency to extend the vaccine’s approval to include adolescents aged 12–17. The company is also working with organizations like CEPI to assess the vaccine’s safety and efficacy in children aged 2–12.

During the mpox outbreak of 2022–2023, Bavarian Nordic supported authorities and international organizations by increasing vaccine availability to over 70 countries worldwide. The company has long been supplying vaccines to national stockpiles.

This news comes less than a week after Bavarian Nordic’s shares rose 13% following strong earnings reports; the company’s second-quarter revenues exceeded 1.4 billion Danish kroner, equivalent to nearly $213 million.

The company also announced that it has secured a contract to supply an undisclosed European nation with 440,000 doses of vaccines against mpox and smallpox. Bavarian Nordic stated that this order was already accounted for in the company’s initial forecast for 2024 and will not impact the remaining capacity for this year.

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