March 31 (Reuters) - Denmark's Bavarian Nordic ( BVNKF )

said on Monday the U.S. Food and Drug Administration has

approved a freeze-dried formulation of its mpox and smallpox

vaccine.

The company said the newly approved formulation of its

vaccine, Jynneos, provides advantages in terms of

transportation, storage conditions and shelf life, which are

important factors for long-term stockpiling.

The vaccine's liquid-frozen formulation, which was approved

by the FDA in September 2019, had specific cold-chain

requirements, Bavarian Nordic ( BVNKF ) said.

The approval was primarily based on clinical data that

showed comparability in terms of the immune responses and safety

between the freeze-dried and liquid-frozen formulations, the

company said.

Freeze-drying is a method used to remove water from a

product, to extend its shelf life and stability.

Bavarian Nordic ( BVNKF ) said it was contracted by the U.S Biomedical

Advanced Research and Development Authority to develop and

supply the freeze-dried version of Jynneos for stockpiling.

Manufacturing under this contract was initiated in 2024, and

the first vaccines will be delivered later in 2025, it added.

In February, the World Health Organization said the mpox

outbreak is still a public health emergency. Globally, there

have been more than 25,000 cases confirmed by laboratory testing

since the beginning of 2024, and over 70 deaths, mainly in

Congo, according to the WHO.

As per the WHO, the United States is one of 18 countries

with the new form of mpox, clade Ib, with 4 cases since the

start of 2024, as of March 21.