Bavarian Nordic's Smallpox and Mpox Vaccine Approved in Singapore

COPENHAGEN, Denmark, August 27, 2024 – Bavarian Nordic A/S (OMX: BAVA) has announced that Singapore’s Health Sciences Authority (HSA) has approved the use of JYNNEOS® (MVA-BN) for the prevention of smallpox and mpox in adults aged 18 and over who are at high risk for these infections. This approval transitions JYNNEOS from emergency use authorization to full approval in Singapore, following its deployment during the recent mpox outbreak.

Paul Chaplin, President and CEO of Bavarian Nordic, emphasized the significance of this approval in light of the World Health Organization's (WHO) declaration that mpox remains a Public Health Emergency of International Concern. Chaplin noted that removing barriers to vaccine access globally is crucial and expressed satisfaction in adding Singapore to the list of countries that have approved the vaccine. Bavarian Nordic is also collaborating with regulators in other regions to expand access to the vaccine, including supporting the WHO Emergency Use Listing process and working with the Africa CDC to ensure the vaccine’s availability in Africa, where there is an urgent need for prophylactic solutions.

The MVA-BN, marketed as JYNNEOS® in the U.S., Switzerland, and Singapore, IMVAMUNE® in Canada, and IMVANEX® in the EU/EAA and the United Kingdom, is a non-replicating smallpox vaccine. It is the only mpox vaccine approved in these regions. Initially developed with the U.S. government to extend smallpox vaccine coverage to immunocompromised individuals who cannot receive traditional replicating vaccines, MVA-BN is now indicated for adults at risk of smallpox or mpox infection.

Bavarian Nordic recently submitted data from a clinical study conducted by the U.S. National Institutes of Health (NIH) to the European Medicines Agency, aiming to extend the vaccine’s approval to adolescents aged 12-17. The company is also collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI) to evaluate the vaccine's safety and efficacy in children aged 2-12.

The company has been a reliable supplier of the smallpox/mpox vaccine to national stockpiles and played a crucial role during the 2022-2023 mpox outbreak by expanding vaccine access to over 70 countries. 

Bavarian Nordic is a fully integrated vaccine company dedicated to protecting and saving lives through innovative vaccines. The company is a global leader in smallpox and mpox vaccines, working in partnership with governments to enhance public health preparedness. It also boasts a diverse portfolio of vaccines targeting travelers and endemic diseases.

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