The US Food and Drug Administration (FDA) has approved the expanded use of Emergent BioSolutions’ ACAM2000 smallpox vaccine to include people at high risk for mpox. This decision was announced on Thursday by the company.
Earlier this month, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years, as a new variant called clade Ib rapidly spread in Africa.
The FDA’s approval comes after Emergent applied for an Emergency Use Listing of the ACAM2000 vaccine with the WHO.
Emergent also announced it would donate 50,000 doses of the smallpox vaccine to the Democratic Republic of the Congo and other affected countries including Burundi, Kenya, Rwanda, and Uganda to help control the mpox outbreak.
The US Centers for Disease Control and Prevention (CDC) notes that ACAM2000 has more known side effects compared to the Jynneos vaccine from Bavarian Nordic, which is approved in the US for both smallpox and mpox. ACAM2000, a live virus vaccine, is known to cause myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining around the heart) in about 1 in 175 new recipients, according to the FDA.
The US Food and Drug Administration (FDA) has approved the expanded use of Emergent BioSolutions’ ACAM2000 smallpox vaccine to include people at high risk for mpox. This decision was announced on Thursday by the company.
Earlier this month, the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years, as a new variant called clade Ib rapidly spread in Africa.
The FDA’s approval comes after Emergent applied for an Emergency Use Listing of the ACAM2000 vaccine with the WHO.
Emergent also announced it would donate 50,000 doses of the smallpox vaccine to the Democratic Republic of the Congo and other affected countries including Burundi, Kenya, Rwanda, and Uganda to help control the mpox outbreak.
The US Centers for Disease Control and Prevention (CDC) notes that ACAM2000 has more known side effects compared to the Jynneos vaccine from Bavarian Nordic, which is approved in the US for both smallpox and mpox. ACAM2000, a live virus vaccine, is known to cause myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining around the heart) in about 1 in 175 new recipients, according to the FDA.