The U.S. Food and Drug Administration gave the nod to Emergent BioSolutions’ smallpox vaccine for mpox.

With the FDA’s approval, Emergent BioSolutions’ shot becomes the second vaccine for mpox approved in the United States.

“FDA approves Emergent BioSolutions’ ACAM2000 vaccine (live vaccinia virus) for MPOX, which has black box warnings for myopericarditis, encephalitis, and severe vaccinial infections that can result in severe disability and/or death,” McCullough Foundation wrote.

“The approval is for prevention of MPOX disease in individuals determined to be at high risk for MPOX infection. The vaccine was first approved by the FDA in 2007 for active immunization for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection,” it continued.

“The decision to approve this vaccine for MPOX prevention is concerning, especially given its known risks. Considering that the alternative MPOX vaccine (JYNNEOS) has a significantly better safety profile and that Tecovirimat has demonstrated effectiveness in treating MPOX, this approval raises serious questions about the prioritization of safety,” it added.

JUST IN – FDA approves Emergent BioSolutions’ ACAM2000 vaccine (live vaccinia virus) for MPOX, which has black box warnings for myopericarditis, encephalitis, and severe vaccinial infections that can result in severe disability and/or death.

The approval is for prevention of… pic.twitter.com/yWPdSbq9Df

— McCullough Foundation (@McCulloughFund) August 31, 2024

* Image from McCullough Foundation X Post *

From Emergent BioSolutions:

Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000® vaccine was shown to be effective in protecting against mpox virus exposure.

ACAM2000® is a single-dose vaccine administered percutaneously via a bifurcated needle that is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine.

The vaccine was first approved by the FDA in 2007 for active immunization for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. Mpox, previously called monkeypox, is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus. The virus is a member of the Orthopoxvirus genus in the Poxviridae family, related to the virus which caused smallpox, which was eradicated in 1980.

Emergent BioSolutions’ stock soars 23% after FDA approves its smallpox vaccine for mpox https://t.co/o3VsMVgJYy

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Fierce Pharma reports:

Mpox is a zoonotic disease that can be spread from animals to humans. Emergent’s vaccine option is administered by a needle dipped in the vaccine solution and pricked into the upper arm several times to deliver a droplet of the vaccine.

With a recently identified mpox strain called the clade Ib variant leading to viral spread across Africa, the World Health Organization (WHO) has declared the ongoing outbreak a public health emergency. So far, the virus has spread to 12 African countries and stacked up a count of more than 2,000 confirmed cases and 517 deaths, according to the Africa Centres for Disease Control and Prevention.

Emergent last week linked up with the U.S. government and the World Health Organization (WHO) to donate 50,000 doses of ACAM2000 to the impacted countries the Democratic Republic of Congo, Burundi, Kenya, Rwanda and Uganda through relief organization Direct Relief.