Bavarian Nordic Receives Full Approval for JYNNEOS Vaccine in Singapore
Bavarian Nordic A/S (OMX: BAVA) has announced that Singapore’s Health Sciences Authority (HSA) has granted full approval for its JYNNEOS vaccine, designed to prevent smallpox and mpox disease. This approval is specifically for adults aged 18 and older who are considered at high risk for these infections.
The move from emergency use authorization to full approval represents a significant milestone, especially since the vaccine was initially used under emergency provisions during the recent mpox outbreak. This decision aligns with similar actions taken by other nations in response to pressing public health needs.
Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, expressed his approval of this recent decision, stating, “The recent declaration from the World Health Organization (WHO) about mpox being a Public Health Emergency of International Concern highlights the need to improve access to approved vaccines globally. Singapore's approval of our vaccine is a significant achievement. We are committed to working with other regulators to expand access considerably.”
About the JYNNEOS Vaccine
JYNNEOS, scientifically referred to as MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic, is a non-replicating smallpox vaccine. It is the only mpox vaccine approved in several countries, including the U.S. (marketed as JYNNEOS), Switzerland, Singapore, Canada (IMVAMUNE), as well as within the EU/EAA and the United Kingdom (IMVANEX). This vaccine was developed to be suitable for the entire population, including those who are immunocompromised and cannot receive traditional live vaccines.
Clinical Research and Future Developments
Clinical data supporting MVA-BN has been gathered through research conducted by the U.S. National Institutes of Health (NIH). Bavarian Nordic is also seeking extension approvals from the European Medicines Agency for use in adolescents aged 12 to 17 years. Additionally, the company is collaborating with partners, including the Coalition for Epidemic Preparedness Innovations (CEPI), to evaluate the vaccine's safety and efficacy in younger children aged 2 to 12 years.
Bavarian Nordic's Contribution to Public Health
Bavarian Nordic has played a crucial role in supplying the JYNNEOS vaccine to various national stockpiles. During the mpox outbreak from 2022 to 2023, the company significantly contributed to increasing vaccine distribution and access across over 70 countries, thereby supporting global public health efforts.
This vaccine not only serves as an immediate preventive measure but also enhances global health preparedness, enabling countries to effectively manage and combat potential outbreaks.
Company Mission and Vision
Bavarian Nordic is dedicated to protecting and saving lives through innovative vaccines. As a global leader in smallpox and mpox vaccines, they collaborate closely with governments to strengthen public health initiatives. Their extensive portfolio also addresses the needs of travelers and targets endemic diseases, reinforcing their mission to uphold global health standards.
For further inquiries, Bavarian Nordic can be contacted directly: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43, or Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600.
Frequently Asked Questions
What is the significance of the approval in Singapore?
The approval in Singapore represents a transition from emergency use authorization to full regulatory approval for the JYNNEOS vaccine, enhancing public health preparedness against smallpox and mpox.
What is JYNNEOS used for?
JYNNEOS is used to prevent smallpox and mpox disease in adults who are considered at high risk for these infections.
How does MVA-BN differ from traditional vaccines?
MVA-BN is a non-replicating vaccine, making it suitable for individuals who are immunocompromised and cannot receive live vaccines.
How many countries have approved the JYNNEOS vaccine?
The JYNNEOS vaccine has received approval in several countries, including the U.S., Switzerland, Singapore, and members of the EU/EAA, showcasing strong international recognition.
What future plans does Bavarian Nordic have?
Bavarian Nordic is pursuing additional approvals to extend the vaccine's use to adolescents and is researching its safety in younger children, reflecting their commitment to broader vaccine access.
