![Approval of Vaccine for Mpox [Potential Link to Shingles Following Covid Vaccination] Issued by FDA...](/en/content/images/size/w1280/format/webp/20250819003737_fda-approved-vaccine-for.jpeg)
Approval Granted for Mpox Vaccine by FDA; Warns of Potential Fatal Consequences for Vaccinated Individuals and Their Contacts
The U.S. Administration for Strategic Preparedness and Response at the HHS has recently signed a $99.9 million deal with Emergent BioSolutions to obtain more ACAM2000 doses this year, although the exact number of doses was not disclosed. This vaccine, initially approved for smallpox in 2007, has been repurposed for mpox following the FDA's approval in August 2022.
ACAM2000, manufactured by Emergent BioSolutions, is a vaccine for biochemical warfare threats. It contains a live vaccinia virus, which can be spread to and potentially cause death in people with 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, warning of "serious complications" such as myocarditis, death, and fetal death. Myocarditis and pericarditis, inflammation of the heart muscle and its lining, are documented serious adverse effects linked to ACAM2000 vaccination. These conditions can cause chest pain and other cardiac symptoms.
Death has been reported rarely after ACAM2000 vaccination, mainly due to severe vaccine-related complications such as progressive vaccinia or encephalitis, especially in individuals with weakened immune systems. Fetal death risk is not explicitly detailed in the sources found, but smallpox vaccination is generally contraindicated in pregnancy due to live virus use and the risk of fetal vaccinia.
The risks for serious vaccine side effects are greater for people who have heart problems or a history of heart problems, are taking steroid eye drops or ointment, have a weakened immune system, have skin problems, are less than 1 year old, are pregnant or become pregnant within 6 weeks after vaccination, or are unvaccinated contacts accidentally infected by individuals who have been vaccinated.
In addition to these risks, vaccinated persons can transmit vaccinia virus to close contacts through skin-to-skin contact or contact with contaminated materials, risking serious complications especially for immunocompromised people, pregnant women, or individuals with eczema.
While the U.S. currently has over 100 million doses of ACAM2000, the CDC does not currently recommend ACAM2000 for mpox. Instead, they advocate for JYNNEOS, the alternate to ACAM2000 in the United States, which has fewer side effects.
Despite these risks, the FDA's approval of ACAM2000 for use against mpox followed just days after Emergent BioSolutions pledged to donate 50,000 doses to address the mpox outbreak in Africa. It is crucial to weigh the benefits and risks of vaccination, especially in the context of a global health crisis, and to continue monitoring the situation closely.
- Articles about health and wellness should discuss the risks associated with ACAM2000, a vaccine for biochemical warfare threats that has been repurposed for mpox, which can cause serious complications such as myocarditis, death, and fetal death, and transmission to close contacts and immunocompromised people.
- The FDA's approval of ACAM2000 for use against mpox raises questions about the science behind its safety and efficacy, given its known side effects and contraindications in certain populations.
- Despite the risks, solutions for addressing global health crises like mpox may involve balancing the potential benefits of vaccines like ACAM2000 with their risks, while prioritizing safer alternatives like JYNNEOS where available.
