Approval of Vaccine for Mpox [Alleged Covid Vaccine Side Effect of Shingles] Issued with Caution Regarding Potential Fatalities for both Vaccinated Individuals and their Contacts
The U.S. Administration for Strategic Preparedness and Response at the Department of Health and Human Services (HHS) has signed a $99.9 million deal with Emergent BioSolutions to acquire more ACAM2000 doses this year. The exact number of doses has not been disclosed.
ACAM2000, a vaccine for mpox, was recently approved by the Food and Drug Administration (FDA). However, it's essential to note that ACAM2000 is a live, replication-competent vaccinia virus vaccine, which carries certain risks.
The FDA requires the ACAM2000 medication guide to be given to patients before they receive the vaccine. This guide lists several serious possible complications, including myocarditis, inflammation of the brain or spinal cord, serious skin infections, and fetal death if taken during pregnancy.
Some of the most important risks associated with ACAM2000 include progressive vaccinia, eczema vaccinatum, ocular vaccinia, myocarditis and/or pericarditis, serious generalized vaccinia, secondary bacterial infection of the vaccination site, and transmission of the vaccine virus to close contacts.
Key populations warned against receiving ACAM2000 include those with weakened immune systems, certain skin conditions, pregnant people, people with serious heart disease, and close household contacts of such individuals.
Emergent BioSolutions has pledged to donate 50,000 doses to address the mpox outbreak in Africa. The U.S. stockpile contains over 100 million doses of ACAM2000.
The FDA's expanded supplement approval for ACAM2000's use against mpox was issued on Aug 29. The risk of myopericarditis is estimated to be around 1 in every 175 people who receive the ACAM2000 vaccine.
It's crucial that people who receive ACAM2000 are aware of the potential risks and follow the guidelines provided by the FDA. ACAM2000 was initially approved for smallpox in 2007, and it is manufactured by Emergent BioSolutions, a company specializing in vaccines for biochemical warfare threats.
The Centers for Disease Control and Prevention (CDC) website states that ACAM2000 has not been used in the ongoing clade II mpox outbreak that started in 2022, but it has been made available for use against mpox under an Expanded Access Investigational New Drug (EA-IND) protocol.
- To ensure the safety of those receiving ACAM2000, the FDA mandates a medication guide be provided before vaccination, outlining potential health risks like progressive vaccinia, myocarditis, and fetal death during pregnancy.
- In a bid to combat the mpox outbreak in Africa, Emergent BioSolutions plans to donate 50,000 doses of ACAM2000, while the U.S. stockpile possesses over 100 million doses of the healthcare-and-wellness product.
- The value of scientific articles discussing the risks, benefits, and possible solutions for health-related issues like mpox becomes increasingly important as vaccines like ACAM2000 play significant roles in global health.
