Emergent BioSolutions Inc. (EBS) has recently received FDA approval for ACAM2000, a new preventive vaccine aimed at protecting high-risk individuals from mpox. Initially authorized for smallpox in 2007, this single-dose vaccine has now been granted an expanded indication to include mpox.The FDA’s decision is underpinned by extensive data from human safety trials and animal studies, which demonstrate the vaccine’s efficacy against the mpox virus. Furthermore, Emergent has requested the World Health Organization (WHO) to include ACAM2000 on its Emergency Use list, signifying its dedication to global health initiatives.CEO Joe Papa highlighted the importance of this expanded approval, especially as the global health community strives to address the recent rise in mpox cases. He conveyed confidence in Emergent’s ability to support global efforts by collaborating with health authorities and utilizing their existing vaccine stock, with plans for scaling up production as needed.With this authorization, ACAM2000 becomes the second vaccine approved for mpox in the U.S., alongside Bavarian Nordic’s Jynneos. Both vaccines utilize a strain of the vaccinia virus, similar to smallpox and mpox viruses but less potent. ACAM2000 employs a live, infectious version of the vaccinia virus, administered via small punctures in the skin using a bifurcated needle, resulting in scabbing at the injection site. This method carries a potential risk of the live virus spreading to other body parts or to other individuals until the scab fully heals.Recently, Emergent partnered with the U.S. government and the WHO to donate 50,000 doses of ACAM2000 to countries affected by mpox through Direct Relief. As of August 2024, there are four approved mpox vaccines 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.The material has been provided by InstaForex Company – www.instaforex.com
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