Emergent Donates 50,000 Smallpox Vaccine Doses Amid mpox Outbreak

Emergent BioSolutions announced it will donate 50,000 doses of its smallpox vaccine to the Democratic Republic of the Congo and neighboring countries to combat a new mpox outbreak. The World Health Organization recently declared mpox a global health emergency as a new variant emerges. Emergent's ACAM2000 vaccine, currently unapproved for mpox by the U.S. FDA, presents certain health risks.

Emergent BioSolutions announced on Monday its donation of 50,000 smallpox vaccine doses to the Democratic Republic of the Congo and other affected countries including Burundi, Kenya, Rwanda, and Uganda, in a bid to address the current mpox outbreak.

The World Health Organization declared mpox a global public health emergency last week for the second time in two years, as a new variant, identified as clade Ib, spreads rapidly in Africa. Notably, Sweden has confirmed its first case of this variant, marking its spread outside Africa. Though Emergent's ACAM2000 vaccine is approved for smallpox, it remains unapproved for mpox by the U.S. FDA.

The U.S. Centers for Disease Control and Prevention has reported that ACAM2000, a live, replicating virus vaccine, has more known side effects compared to the Jynneos vaccine from Bavarian Nordic A/S, which is approved for both smallpox and mpox in the U.S. ACAM2000 is linked to a risk of myocarditis and pericarditis in 1 in 175 recipients, according to the FDA. The vaccine is administered via multiple skin punctures using a two-pronged needle, and the resulting scab forms a potential vector for virus transmission until it heals within 2-4 weeks. The vaccine is not recommended for individuals with compromised immune systems, such as those with HIV.