Aug 29 (Reuters) - The U.S. Food and Drug Administration

(FDA) has approved expanded use of Emergent BioSolutions' ( EBS )

ACAM2000 smallpox vaccine to include people at high risk

for mpox infection, the company said on Thursday.

Earlier this month, the World Health Organization declared

mpox a global public health emergency for the second time in two

years as a new variant of the virus, known as clade Ib, spread

rapidly in Africa.

The FDA's approval follows Emergent's application for an

Emergency Use Listing of ACAM2000 vaccine with the WHO.

Emergent last week said it would donate 50,000 doses of its

smallpox vaccine to the Democratic Republic of the Congo and

other impacted countries of Burundi, Kenya, Rwanda and Uganda to

address the mpox outbreak.

According to the U.S. Centers for Disease Control and

Prevention, ACAM2000 has more known side effects and risks than

Danish biotech Bavarian Nordic A/S's ( BVNKF ) Jynneos vaccine,

which is approved in the United States for both smallpox and

mpox.

ACAM2000 - a live, replicating virus vaccine - is known to

cause myocarditis/pericarditis - swelling in or around the heart

muscle - in 1 in 175 new ACAM2000 vaccine recipients, according

to the FDA.