Freeze-Dried Smallpox and Mpox Vaccine May Soon Be Available

Introduction to the New Vaccine Formulation

Bavarian Nordic has made significant strides with its latest vaccine development. The company has recently filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) to approve a freeze-dried version of their JYNNEOS® vaccine for smallpox and mpox for use in adults.

What is JYNNEOS®?

JYNNEOS® is a vaccine designed to protect against smallpox and mpox. Initially approved by the FDA in 2019, this vaccine uses a non-replicating method, making it safe for various populations, including those with compromised immune systems.

The current formulation of JYNNEOS® requires strict cold-chain logistics, which can be challenging for transportation and storage. The freeze-dried version offers a more flexible option, ideal for long-term stockpiling and easier dissemination in emergency scenarios.

Clinical Studies and Data

The sBLA is backed by robust clinical data from both Phase 2 and Phase 3 studies. These studies demonstrated that the freeze-dried formulation is bioequivalent to the liquid-frozen version. This indicates that the two formulations have similar efficacy and safety profiles.

Additional data supporting the application includes extensive process development and manufacturing details. This comprehensive set of data ensures that the new formulation meets all necessary safety and efficacy standards.

Impact on Public Health

The approval of the freeze-dried JYNNEOS® formulation has the potential to significantly enhance public health preparedness. Long-term stockpiling of vaccines is crucial for rapid response to potential outbreaks. The new formulation's extended shelf life and ease of storage will be beneficial for strategic national stockpiles.

This innovation comes at a crucial time as the world continues to deal with the implications of various infectious diseases. A more adaptable vaccine will greatly assist in managing public health crises.

Bavarian Nordic's Ongoing Commitments

Bavarian Nordic has a long-standing contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) valued at approximately USD 300 million. This contract supports the production of the freeze-dried JYNNEOS® doses before their official approval, ensuring that supplies are ready for use once the formulation is licensed.

Manufacturing began in the early months of 2024, with initial deliveries expected within the year. This move highlights Bavarian Nordic's proactive approach to meeting public health needs.

Future Prospects and Benefits

The freeze-dried formulation is particularly advantageous for its improved logistical properties. Unlike its liquid-frozen counterpart, it can endure various transportation conditions and longer storage times, making it an asset for both developed and developing nations.

This extended shelf life and reduced need for specialized storage make the vaccine more accessible, potentially increasing global vaccination rates against smallpox and mpox.

About Bavarian Nordic

Bavarian Nordic is a leading vaccine company dedicated to creating innovative solutions to combat infectious diseases. With a strong portfolio that includes smallpox and mpox vaccines, the company is at the forefront of public health preparedness.

Founded on a mission to save lives through vaccines, Bavarian Nordic collaborates closely with global health authorities to distribute vaccines that are both safe and effective.

Global Impact During the Mpox Outbreak

During the recent mpox outbreak between 2022 and 2023, Bavarian Nordic played a crucial role in providing vaccines to over 70 countries. This effort helped contain the spread and reduce the impact of the outbreak.

The expansion of vaccine access to a global scale highlights the company's commitment to addressing public health challenges worldwide.

Funding and Support

The development of the freeze-dried JYNNEOS® vaccine has been significantly supported by U.S. federal funds. The project is part of broader efforts by the U.S. Department of Health and Human Services to bolster national biological preparedness.

This collaboration with government agencies underscores the importance of public-private partnerships in advancing public health.