Federal Authorization Granted for Vaccine Against Mpox [Shingles Linked to Covid Vaccine] with Caution Regarding Fatality Risk for Inoculated Individuals and Those Near Them
In a recent development, the Food and Drug Administration (FDA) has approved the ACAM2000 vaccine for use against mpox, a virus that has been causing outbreaks around the world. However, it's essential to understand that this vaccine comes with several known serious complications.
ACAM2000 is a live, replication-competent vaccinia virus vaccine, which means it can potentially cause severe infections, especially in people with weakened immune systems or skin conditions. The complications associated with ACAM2000 include progressive vaccinia, eczema vaccinatum, myocarditis, pericarditis, and spreading of the vaccinia virus infection to other parts of the body, such as the eyes, brain, or heart, potentially causing long-term damage.
These complications primarily occur through local reactions at the vaccination site, systemic reactions, severe infections, and heart complications. Local reactions may include redness, tenderness, swelling, blistering, and lesion formation that typically scars. Systemic reactions can involve fever, headache, fatigue, muscle aches, and swollen lymph nodes. Severe infections are a concern due to the live virus in the vaccine, especially in people with weakened immune systems or skin conditions. Heart complications like myocarditis and pericarditis have been reported, although they are uncommon.
For those in close contact with vaccinated individuals, the complications arise because the vaccine virus can be shed from the lesion at the vaccination site. If the lesion is not kept clean and covered, the vaccinia virus can be transmitted to others, causing infections, especially in individuals who are immunocompromised or have skin conditions.
Given these risks, it's crucial for vaccinated persons to keep the vaccination site covered, maintain hygiene, and avoid close contact with vulnerable individuals. In case of serious adverse symptoms such as swelling in face or throat, breathing difficulties, chest pain, or spreading rash, urgent medical attention is recommended.
Notably, Emergent BioSolutions, the manufacturer of ACAM2000, has pledged to donate 50,000 doses of the vaccine to address the mpox outbreak in Africa. The U.S. stockpile contains more than 100 million doses of ACAM2000.
It's worth mentioning that JYNNEOS, an alternate to ACAM2000 in the United States, has fewer side effects. However, no mpox-specific antiviral is FDA-approved yet, and treatment for serious complications may include vaccinia immune globulin intravenous (VIGIV) and antiviral agents.
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 a controversial stance, Karl Jablonowski, a senior research scientist at Children's Health Defense, stated that the FDA's approval of the shot is a "public hazard, not the practice of public health."
Despite these risks, the CDC acknowledges that ACAM2000 has not been used in the ongoing 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.
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.
In conclusion, while the ACAM2000 vaccine offers a potential solution against mpox, it's crucial to be aware of the significant risks associated with its use. Vaccinated individuals must take precautions to minimize the risk of complications, and those in close contact with vaccinated individuals should exercise caution to avoid transmission of the vaccine virus.
- The FDA-approved ACAM2000 vaccine, used against mpox, has possible severe complications.
- Local reactions to the vaccine may include redness, swelling, or lesion formation, typically leading to scarring.
- Systemic reactions, such as fever, headache, and muscle aches, can also occur.
- Severe infections are a concern, particularly for individuals with weakened immune systems or skin conditions.
- For those in close contact with vaccinated individuals, it's important to maintain hygiene and avoid transmission of the vaccine virus.
- JYNNEOS, an alternative vaccine in the United States, has fewer side effects, but no mpox-specific antiviral treatments are FDA-approved yet, with treatments for serious complications including VIGIV and antiviral agents.
