Vaccine for Mpox (previously known as Covid Vaccine Induced Shingles) Granted Approval by FDA; Carry Potential Risk of Fatality in Vaccinated Individuals and Those They Interact With

Vaccine for Mpox (previously known as Covid Vaccine Induced Shingles) Granted Approval by FDA; Carry Potential Risk of Fatality in Vaccinated Individuals and Those They Interact With

The U.S. has a stockpile of over 100 million doses of ACAM2000, a vaccine developed by Emergent BioSolutions, a company specializing in vaccines for biochemical warfare threats. This vaccine, recently approved by the FDA for mpox prevention, carries specific risks and side effects.

ACAM2000, a live replicating vaccinia virus vaccine, induces immunity against mpox and related orthopoxviruses. However, it comes with potential complications. Common side effects include injection site reactions, fever, headache, muscle pain, fatigue, chills, swollen lymph nodes, and nausea. A characteristic lesion forms at the vaccination site within 3 to 4 days, which blisters, scabs, and scars over, indicating successful vaccination.

However, there are serious risks associated with ACAM2000. Myocarditis and pericarditis, inflammation of the heart muscle and lining, respectively, have been reported after vaccination. The estimated risk of myopericarditis linked to ACAM2000 is not precisely quantified, but it is recognized as a notable adverse event.

Another concern is the potential for virus transmission. Because ACAM2000 contains a live, replication-competent vaccinia virus, the virus can spread from the vaccination site to other parts of the vaccinated person’s body or to unvaccinated close contacts through direct contact with the lesion or contaminated material.

ACAM2000 is contraindicated for people with weakened immune systems, skin conditions, pregnant women, and others at higher risk for serious adverse effects. These contraindications are due to the live virus replication potential and associated risk of severe vaccinia complications like progressive vaccinia.

It's important to note that ACAM2000 can cause fetal death when taken during pregnancy and can be spread to and potentially cause the death of people who have close contact with the vaccinated person up to 6 weeks following vaccination.

The FDA requires every person receiving ACAM2000 to be given the drug's FDA-approved medication guide, which lists serious possible complications, including myocarditis, inflammation of the brain or spinal cord, serious skin infections, and fetal death if taken during pregnancy.

In August, the FDA issued an expanded supplement approval for ACAM2000's use against mpox. The U.S. Administration for Strategic Preparedness and Response at the HHS signed a $99.9 million deal with Emergent BioSolutions to obtain more ACAM2000 doses this year, but the exact number of doses was not disclosed.

Recently, Emergent BioSolutions pledged to donate 50,000 doses to address the mpox outbreak in Africa. Despite these efforts, it's crucial to be aware of the risks associated with ACAM2000 to ensure its safe and effective use.

[1] FDA-authorized guide for ACAM2000 [2] ACAM2000 package insert [3] Centers for Disease Control and Prevention (CDC) [4] World Health Organization (WHO) [5] National Institutes of Health (NIH)

1. To ensure the safe and effective use of ACAM2000, it is crucial to read the FDA-authorized guide for ACAM2000 before receiving the vaccine.
2. Articles on the health-and-wellness implications of ACAM2000 should include information about the potential risks associated with the vaccine, such as myocarditis, inflammation of the brain or spinal cord, and serious skin infections.
3. In the context of solutions to global health challenges, it is worth considering the various guidelines and resources available for ACAM2000, such as the CDC, WHO, and NIH.

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