Emergent's Smallpox Vaccine For Mpox Receives FDA Approval

(RTTNews) - Emergent BioSolutions Inc. (EBS) has recently obtained FDA approval for a new preventive vaccine, known as ACAM2000, designed to protect individuals at high risk from mpox. This single-dose vaccine, initially authorized for smallpox in 2007, has now been granted an expanded indication.

The FDA's decision is based on comprehensive data from human safety trials and animal studies that demonstrate the vaccine's effectiveness against the mpox virus. Notably, Emergent has also requested the World Health Organization (WHO) to list the ACAM2000 vaccine for Emergency Use, reflecting its commitment to global health initiatives.

CEO Joe Papa emphasized the significance of this expanded approval, particularly as the global health community works together to combat the recent surge in mpox cases. He expressed confidence in Emergent's capacity to contribute to the global response by actively engaging with health authorities and utilizing existing vaccine inventory, with plans to scale up production as necessary.

With this approval, ACAM2000 became the second vaccine authorized for mpox in the U.S., joining Bavarian Nordic's (BAVA.CO) Jynneos. Both vaccines contain a strain of the vaccinia virus, which shares similarities with smallpox and mpox viruses but is less harmful. Notably, ACAM2000 involves the use of a live, infectious version of the vaccinia virus, administered through small punctures in the skin using a two-pronged needle, leading to scabbing at the injection site. This approach presents a potential risk of the live virus spreading to other parts of the body or other individuals until the scab has fully healed.

In a recent development, Emergent has collaborated with the U.S. government and the WHO to donate 50,000 doses of ACAM2000 to mpox affected countries through Direct Relief. As of August 2024, there are four approved vaccines for mpox globally: Emergent BioSolutions' ACAM2000, Bavarian Nordic's Jynneos, K.M. Biologics' LC16 "KMB" freeze-dried smallpox vaccine from Japan, and OrthopoxVac from the State Research Center of Virology and Biotechnology Vector Laboratories.