Emergent BioSolutions’ ACAM2000® Receives FDA Approval for Mpox Indication
Emergent BioSolutions Inc. (NYSE: EBS) has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ACAM2000®, a live smallpox and mpox (Vaccinia) vaccine. This approval allows for the prevention of mpox disease in individuals identified as being at high risk for infection. This decision is supported by existing human safety data and results from a controlled animal study demonstrating the vaccine's efficacy against the mpox virus.
ACAM2000®: A Single-Dose Vaccine
ACAM2000® is administered as a single-dose vaccine via a bifurcated needle technique, in which the needle is dipped into the vaccine solution and the skin is pricked multiple times with the vaccine droplet on the upper arm.
Historical Context of ACAM2000®
Initially approved by the FDA in 2007, ACAM2000® was designated for the active immunization against smallpox disease in individuals at high risk for smallpox infection. Mpox, formerly known as monkeypox, is an infectious disease endemic to certain regions caused by the mpox virus, which is part of the Orthopoxvirus genus in the Poxviridae family, related to the virus that caused smallpox, which was eradicated in 1980.
Implications of the Approval
“The FDA approval of ACAM2000® for immunization against mpox in high-risk individuals fortifies our smallpox vaccine portfolio, which encompasses other products such as VIGIV® and TEMBEXA®,” stated Joe Papa, the president and CEO of Emergent. “This expanded indication comes at a crucial moment as the global health community strives to mount an effective response to the recent rise in mpox cases.” Emergent BioSolutions is actively participating in global health discussions and readiness efforts aimed at addressing public health needs associated with mpox outbreaks.
Global Health Emergency and Support from Emergent
This FDA approval arrives at a time when mpox has escalated to a significant public health concern. Emergent has committed to donating 50,000 doses of ACAM2000® to support public health initiatives in regions impacted by mpox outbreaks, particularly in Central Africa. The epidemiological increase in mpox cases necessitates leveraging available and effective vaccination strategies.
Understanding Mpox Variants and Risks
Reports have highlighted that the clade I variant of mpox presents more severe clinical outcomes and a higher mortality rate, necessitating prompt intervention. Furthermore, the recently identified clade Ib variant is known for heightened transmissibility, contributing to increased cases in vulnerable populations, especially among children and families.
About ACAM2000®
ACAM2000® is recognized as the primary smallpox vaccine designated for emergencies related to bioterrorism, with distributions supplied to the U.S. Strategic National Stockpile. This vaccine is not only licensed in the United States but also in other countries, including Canada, Australia, and Singapore.
Safety Profile and Contraindications
While ACAM2000® serves as a crucial tool for preventing smallpox and mpox infections in at-risk individuals, it does carry contraindications. Notably, those with severe immunodeficiency should avoid this vaccination due to the risks associated with progressive vaccinia. Additionally, there are precautions related to potential side effects such as myocarditis, pericarditis, and other significant health risks.
Emergent BioSolutions: Commitment to Public Health
Emergent BioSolutions is dedicated to enhancing life and safeguarding public health amidst complex health challenges. The company crafts innovative solutions tailored for urgent public health threats, supported by a robust portfolio of vaccines and therapeutics. To learn more about their commitment and advancements in health security, one can explore their official channels and communication platforms.
Frequently Asked Questions
What is ACAM2000® used for?
ACAM2000® is indicated for the prevention of smallpox and mpox disease in individuals determined to be at high risk for infection.
What prompted the FDA approval for mpox indication?
The FDA's approval was based on human safety data and a controlled animal study illustrating ACAM2000®'s effectiveness against mpox virus exposure.
Who will benefit from the expanded indication of ACAM2000®?
The approval facilitates vaccination for individuals identified as high-risk, aiding in the management of mpox outbreaks, particularly during global health emergencies.
How does ACAM2000® differ from previous smallpox vaccines?
ACAM2000® uses a modern administration method and is designed as a single-dose vaccine, unlike earlier vaccines that required multiple doses.
Where can I find more information about the safety of ACAM2000®?
Further details regarding the safety and efficacy of ACAM2000® can be found in its prescribing information and clinical resources provided by Emergent BioSolutions.
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