FDA warns monkeypox vaccine may cause death

Sep 18, 2024

FDA Approves Vaccine for Mpox — Warns It May Cause Death in Vaccinated and People They Come in Contact With

ACAM2000, a vaccine approved last month by the FDA for mpox, comes with a list of “serious complications,” including myocarditis, death and fetal death. The FDA’s medication guide also warns that people who receive the vaccine may spread it to unvaccinated people, who also risk developing vaccine side effects, including death.

by Suzanne Burdick, Ph.D.

SEPTEMBER 17, 2024

mpox vaccine bottle and magnifying glass with "fda approved" inside

A vaccine approved in August by the U.S. Food and Drug Administration (FDA) for people deemed to be at “high risk” for mpox infection may cause more harm than good, according to the FDA’s own medication guide for the product.

ACAM2000 — made by Emergent BioSolutions, a company specializing in vaccines for biochemical warfare threats such as anthrax and smallpox — was approved for smallpox in 2007.

However, on Aug. 29, the FDA issued an expanded supplement approval for ACAM2000’s use against mpox.

Since then, social media users have been posting clips of the FDA’s ACAM2000 medication guide, which warns the vaccine may cause “serious complications” in both the vaccinated person and those with whom they come into close contact up to 6 weeks after getting the shot.

Karl Jablonowski, Ph.D. — senior research scientist at Children’s Health Defense — told The Defender that the FDA’s approval of the shot is a “public hazard, not the practice of public health.”

“You can call ACAM2000 a ‘vaccine,’ but its impact on the United States will be as a ‘disease,’” Jablonowski said.

He added:

“For instance, the drug’s package insert reveals (see Table 3) that the U.S. Department of Health and Human Services (HHS) found roughly 520 per million ACAM2000 recipients contracted myocarditis or pericarditis.

“That is about 1 in 2,000. If the 262 million adults in the U.S. received this vaccine, an estimated 136,000 would contract the serious adverse reaction of myopericarditis.”

Myopericarditis is an umbrella term for myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart.

ACAM2000 can also cause fetal death when taken during pregnancy, the package insert states.

Additionally, the shot contains a “live vaccinia virus” that can be spread to — and possibly cause the death of — people who have close contact with the vaccinated person up to 6 weeks following vaccination, according to the medication guide.

The guide — which the FDA requires to be given to patients before they get the ACAM2000 vaccine — says, “ACAM2000 can cause serious complications in vaccinated individuals and in their close contacts to whom the vaccine virus has spread.”

Jablonowski said, “The spread of vaccinia virus is an infliction and an assault, as an unsuspecting person cannot possibly consent.”

“For good reasons you would not consent to this vaccine,” Jablonowski said, “even if you believed your benefits outweigh your risks, as you become a potential vector of a disease that is damaging to the heart and fatal to both fetus and infant.”

Risk of serious complications and death in vaccinated and those exposed to vaccinated individual

ACAM2000 is a single-dose vaccine administered using a bifurcated needle that’s been dipped into the vaccine solution, according to an Emergent BioSolutions press release.

In its Aug. 30 press release, the FDA stressed that “every person” who receives ACAM2000 is “required” to be given the drug’s FDA-approved medication guide.

“A Medication Guide is necessary,” the FDA said, “for safe and effective use of the vaccine because it could help prevent serious adverse events and inform the vaccine recipient of serious risks relative to benefit that could affect their decisions to be vaccinated.”

The guide lists serious possible complications, including: myocarditis, inflammation of the brain or spinal cord, serious skin infections, spreading the vaccine virus through the blood to other parts of the body and fetal death if taken during pregnancy.

According to the guide, “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 such as eczema, atopic dermatitis, burns, impetigo, contact dermatitis, chickenpox, shingles, psoriasis, or uncontrolled acne
are less than 1 year old
are pregnant or become pregnant within 6 weeks after vaccination.”

ACAM2000’s package insert warns of a longer list of possible serious complications, including:

“Myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, accidental eye infection (ocular vaccinia) which can cause ocular complications including keratitis and corneal scarring that may lead to blindness, and fetal death in pregnant women.”

The insert also goes into more detail about the risk of death:

“Historically, death following vaccination with live vaccinia virus is a rare event; approximately 1 death per million primary vaccinations and 1 death per 4 million revaccinations have occurred after vaccination with live vaccinia virus.

“Death is most often the result of sudden cardiac death, post-vaccinial encephalitis, progressive vaccinia, or eczema vaccinatum.

“Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated.”

U.S. stockpile contains more than 100 million doses

The FDA’s approval of ACAM2000 for use against mox followed just days after Emergent BioSolutions pledged to donate 50,000 doses to address the mpox outbreak in Africa.

On July 2, the U.S. Administration for Strategic Preparedness and Response at the HHS signed a $99.9 million deal with the drugmaker to obtain more ACAM2000 doses this year. Although the exact number of doses was not disclosed, Forbes on Sept. 8 reported that the U.S. currently has over 100 million doses.

HHS did not respond when The Defender asked if these doses are reserved for an emergency smallpox outbreak or are being made available as an mpox vaccine.

The Defender reached out to the Centers for Disease Prevention and Control (CDC) with the same question but was told by a CDC spokesperson, “We defer to the Administration for Strategic Preparedness and Response (ASPR) where the National Stockpile is housed.”

The CDC website on mpox vaccination states that ACAM2000 “has not been used in the ongoing clade II mpox outbreak that started in 2022″ but “has been made available for use against mpox in the clade II outbreak under an Expanded Access Investigational New Drug (EA-IND) protocol, which requires informed consent along with completing additional forms.”

When The Defender asked the CDC to clarify if the agency currently recommends ACAM2000 for mpox, an agency spokesperson said:

“It has not been used for U.S. civilians affected by the clade II global outbreak that began in 2022, and there are no plans to use it broadly during Mpox outbreaks.

“This is because JYNNEOS, the alternate to ACAM2000 in the United States, has fewer side effects.”

The Defender asked Emergent BioSolutions what it wants to tell members of the public who may be concerned about risks associated with ACAM2000 but did not receive a response by our deadline.

Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa