March 31, 2025 – Bavarian Nordic, a prominent Denmark-based biotechnology company, received U.S. Food and Drug Administration (US FDA) approval for a freeze-dried formulation of its smallpox and mpox vaccine, Jynneos. This new approval aligns with the company’s goal to expand the versatility and accessibility of its vaccine offerings.
The newly approved freeze-dried version of Jynneos provides a more convenient and stable option for storage and distribution. It is expected to improve the vaccine’s use in emergency response situations and routine immunization programs.
Freeze-drying method, in which water is removed from a product, enhances the product’s shelf life and stability. It is becoming popular in the pharmaceutical industry to preserve sensitive pharmaceutical products like vaccines, enzymes, and biologics.
Earlier, Bavarian Nordic received a contract from the U.S. Biomedical Advanced Research and Development Authority to develop and supply the freeze-dried variants of Jynneos for stockpiling. Under this contract, manufacturing was started in 2024, and first vaccines are expected to be delivered later in 2025, as per the company’s officials.
Cases of Mpox and smallpox across nations like the United States and Congo are rising significantly. This is expected to create a high demand for vaccines in the coming period, leading to growth of the smallpox treatment industry.
According to Coherent Market Insights (CMI), the global smallpox treatment industry size is expected to reach US$ 82 million in 2032. Overall demand for smallpox treatments will likely surge at 2.1% CAGR during the forecast period.
Freeze-dried vaccines improve accessibility by making storage and transportation easier. This is particularly beneficial in regions with limited cold-chain infrastructure, where it can help save lives by ensuring vaccine stability and availability.
“US FDA’s approval will help to tackle Mpox and smallpox burden by enhancing global access to vaccines and treatments. It could also attract more investments in the smallpox treatment industry, including research and development of new treatments and vaccines,” says a senior analyst at CMI.”
The approval of a new version of Bavarian Nordic’s existing Jynneos vaccine may help expand immunization efforts against Mpox and smallpox. It is likely to boost confidence among government and health organizations, encouraging wider adoption and stockpiling of vaccines for emergency preparedness.
Other companies are expected to develop novel versions of smallpox vaccines, including freeze-dried ones. This will eventually boost growth of the global smallpox treatment industry during the forthcoming period.
Sources:
News Outlet: Reuters