Got the mpox shot? You may be a walking biohazard
The government claims that 141 Americans have died due to monkeypox in the past few years since the disease "surged," to use the CDC's terminology. This surge, along with the fear it has engendered, is now being used to justify use of a biohazardous vaccine which leaves those treated able to transmit live vaccinia virus for up to 6 weeks following inoculation.
The vaccine is not new — it was originally approved almost two decades ago, solely for smallpox prevention. Several deaths have been associated with it, both in the inoculated and those who came into contact with them.
According to the CDC, this vaccine has not been used in the past few years for monkeypox, but VAERS reports suggest that this statement is false.
Why has the FDA authorized a dangerous product, especially as a safer alternative exists?
Never let a fake crisis go to waste
At the end of August, the Food and Drug Administration (FDA) approved use of ACAM2000, a smallpox vaccine, for use in people considered to be “at high risk” of monkeypox infection. ACAM2000 is one of 3 vaccines available in the United States for smallpox or monkeypox — the others are the Jynneos vaccine (a third-generation, live attenuated and non-replicating vaccine), and the Aventis-Pasteur smallpox vaccine (which is live and replicating).
ACAM2000 was first licensed in 2007 for immunization against smallpox specifically for people considered at high risk of contracting the disease. It was subsequently made available for immunization against monkeypox under the FDA’s “Expanded Access Investigational New Drug protocol” at the start of what the government calls the “current outbreak,” in 2022. According to the FDA, Expanded Access authorization is only granted when:
- The patient has a serious disease or condition and there is no satisfactory alternative to the “new drug” and
- The potential benefit justifies the risks, which are considered “not unreasonable in the context.”
Given that the Jynneos vaccine is available in the United States and carries substantially fewer risks, it is unclear why ACAM2000 should have been granted Expanded Access approval and the FDA did not give an explanation. The CEO of Emergent BioSolutions, the company that manufactures ACAM200, did however provide a hint in his reference to a so-called mpox “upsurge”:
This expanded indication for ACAM2000® comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases. We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply. [emphasis added]
Since the upsurge surged up from near-zero, there definitely has been a spike in cases reported. That said, even according to the WHO, only 208 people world-wide have died of monkeypox since the start of 2022, out of just under 100,000 laboratory-confirmed cases. Of those, around 63,000 cases were in the Americas where 141 people died over that period. Furthermore, the trend has been downward at least since this spring.
Caution: Live replicating virus
In its ACAM2000 Q&A, the FDA notes that “ACAM2000 is the first vaccine [to be] licensed with a Medication Guide.” The reason for this is that the,
FDA has determined that a Medication Guide is necessary for safe and effective use of the product, because it could help prevent serious adverse events and inform the recipient of serious risks relative to benefit that could affect their decisions to be vaccinated.
This Guide is six pages long and begins with the instruction to “read this Medication Guide and talk to your healthcare provider before you receive ACAM2000.” Following is a very long list of very serious adverse events as well as a warning that the “live vaccinia [cowpox] virus” in the vaccine “can be spread to individuals who have close contact with the vaccinated individual,” causing “serious complications” in them.
It’s to be hoped that people receiving ACAM2000 really will read the Guide. However, surveys have consistently shown that while a majority of people claim that they read patient inserts for drugs, when it comes to vaccines very few people read them — and most aren’t even given them in the first place.
Side-effect: Accidental Death
The “serious complications” the Guide lists include: myocarditis, inflammation of the brain or spinal chord, serious skin infections, death of an exposed fetus, spreading of the vaccine virus throughout the body via the blood, and severe allergic reaction. The only mention of death is in an unborn baby exposed to the vaccine, presumably through contact between the person who got the shot and the pregnant mother.
Emergent BioSolutions’ “Product Monograph” has a similar list of adverse events, and adds that,
These complications may rarely lead to severe disability, permanent neurological sequelae and death. The same complications may arise in unvaccinated individuals who have contact with vaccinated individuals.
Why does the FDA’s Guide omit the risk of dying from the shot? This is doubly curious given that the package insert for ACAM2000 (which most vaccine recipients won’t see) does include the warning:
5.1 Serious Complications
Serious complications that may follow either primary or revaccination with ACAM2000 include: 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.
These complications may rarely lead to severe disability, permanent neurological sequalae and 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.
And, while the Medication Guide refers merely to the possibility that a fetus might die following exposure to someone vaccinated with ACAM2000, the FDA’s more detailed patient insert writes that,
Death has also been reported in unvaccinated contacts accidentally infected by individuals who have been vaccinated. [emphasis added]
Thousand-fold rate of myocarditis
The reasons why people might die following exposure to someone who has been vaccinated are not detailed either by the FDA or by Emergent. VAERS reports from the years 2008 to 2013 (when the vaccine was used solely to address smallpox) reveal 1 death due to myocarditis, plus 169 serious cases out of 1,149 reports. Serious cases, according to VAERS, are those that involve hospitalization and/or permanent disability. Yet the CDC downplays the danger, writing only that, “a few people who have gotten the smallpox vaccine have developed heart inflammation (myocarditis), inflammation of the lining of the heart (pericarditis), or a combination of both…”
In fact, the FDA and Emergent saw very alarming signals during ACAM2000’s clinical trials, with 1 out of every 175 previously healthy adults developing myocarditis following inoculation. That’s a rate of 5,714 cases per million, over a thousand times greater than the background rate (found in the general population) which is 5.5 cases per million.
No such warning of myocarditis is included in FDA information on other pox vaccines such as varicella (chickenpox).
One vial for a hundred vaccinees
But the dangers of ACAM2000 start long before someone is diagnosed with myocarditis. The very administration of the injection involves the danger of contamination.
The person administering the shot begins with vaccine powder, which must be reconstituted using a liquid provided with it. This produces one vial of “approximately 100 doses” which can be stored for up to 30 days, “after which it should be discarded as a biohazardous material.”
Emergent’s Product Monograph stresses the precautions that must be taken:
4.4 Administration:
Wear surgical or protective gloves when preparing and administering the vaccine to avoid contact of vaccine with skin, eyes or mucous membranes...
Remove the vaccine vial cap. Remove bifurcated needle from individual wrapping. Submerge bifurcated end of needle in reconstituted vaccine solution. The needle will pick up a droplet of vaccine (0.0025 mL) within the fork of the bifurcation. Use aseptic technique, i.e., do not insert the upper part of the needle that has been in contact with fingers into the vaccine vial, and never re-dip the needle into the vaccine vial if the needle has touched skin.
This one vial will be used to inoculate around 100 people. Some of them may unknowingly already have monkeypox at the time, and are being inoculated because they came into contact with someone with clear symptoms. One small slip, and the entire vial could become infected with the disease.
15 jabs through a droplet: take care not to splash
The method of inoculation is unlike that of almost all other vaccines:
Deposit the droplet of vaccine onto clean, dry skin of the arm prepared for vaccination ... Rapidly make 15 jabs of the needle perpendicular to the skin through the vaccine droplet to puncture the skin, within a diameter of about 5 mm. The jabs should be vigorous enough so that a drop of blood appears at the vaccination site.
Wipe any excess droplets of vaccine and blood off the skin using a dry gauze pad and discard in a biohazard container. Discard the needle in a biohazard sharps container.
The administrator is then told to wash his hands “with soap and warm water or with alcohol-based hand rubs such as gels or foams after direct contact with the vaccination site, the bandage or clothes, towels or sheets that might be contaminated with virus from the vaccination site. This is vital to remove any virus from your hands and prevent contact spread."
All the bandages, plus the empty vial, the syringe used to dilute the powder with liquid, as well as the needle must be placed in “leak-proof, puncture-proof biohazard containers” and disposed of “appropriately.” The administrator should also,
Wash separately clothing, towels, bedding, or other items that may have come in direct contact with the vaccination site or drainage from the site, using hot water with detergent and/or bleach. Wash hands afterwards.
There are no instructions given for the person receiving the shot to wash up, head straight home, take a shower, and wash all their clothing, although it’s quite conceivable that during the rapid jabs of the needle into a droplet of live, replicating vaccine, some of the liquid could splash onto other parts of their body and/or clothing.
Six weeks of walking biohazard
The vaccination site is then to be covered by a porous bandage that allows air to access the wound, using gauze secured with medical tape. Only if physical contact with other people is “unavoidable” should a semi-permeable dressing be used, in which case the dressing has to be changed every 1 to 3 days due to build-up of fluid beneath it. Emergent BioSolutions is quite clear about the danger of infection from the injection wound, writing that,
Virus is shed from the vaccination site during the period starting with the development of a papule (day 2-5); shedding ceases when the scab separates and the lesion is re-epithelialized...
In primary vaccinees, scab separation occurs 3-6 weeks after vaccination, leaving a pitted scar.
Don't scratch!
How can vaccinees ensure that no one is infected during this weeks-long period? In fact, the danger is not only that the virus spreads to other people — it’s also possible for the person being inoculated to pass the infection to other parts of his own body, with sometimes very unfortunate results.
Accidental infection of skin at sites other than the site of intentional vaccination (inadvertent autoinoculation) is the most frequent complication of vaccinia vaccination and may occur in a vaccinee from trauma or scratching. The most common sites involved are the face, nose, mouth, lips, genitalia, and anus ... Self-inoculation of the eye may result in ocular vaccinia, a potentially serious complication.
To minimize the danger of this happening, those inoculated are told to be scrupulous about their personal hygiene, and to sterilize anything that comes into contact with the wound:
The most important measure to prevent inadvertent autoinoculation and contact transmission from vaccinia vaccination is thorough hand washing after changing the bandage or after any other contact with the vaccination site...
Vaccinia virus may be transmitted by direct physical contact from the vaccination site or drainage from the site and or contaminated bandages to clothing, towels, bedding or other items. Wash hands and wash clothing, towels, bedding or other items that may have come in direct contact with the vaccination site or drainage from the site separately, using hot water with detergent and/or bleach.
Other, FDA-approved advice says: Leave home to protect those you live with
Given the danger of contact for vulnerable people, recently vaccinated people are also advised to,
... avoid close contact with individuals susceptible to adverse effects of vaccinia virus, i.e., those with cardiac disease, eye disease, immunodeficiency states, including HIV infection, eczema, pregnant women and infants, until the scab has separated from the skin at the vaccination site.
How far should one go to avoid “close contact”? The FDA doesn’t specify, but the Army Medical Logistics Command (AMLC), whose medication guide for ACAM2000 has been approved by the FDA, does.
In it, they write:
What should I avoid after getting vaccinated with the ACAM2000 smallpox vaccine?
For 4 weeks after vaccination AND until the vaccination site has healed, you should avoid:
- getting pregnant. Smallpox vaccine may rarely cause infection in an unborn baby if the mother is vaccinated during pregnancy. This infection usually results in stillbirth or death
- handling babies or breastfeeding
- swimming or hot tub use
- donating blood
- rubbing, scratching or touching the vaccination site
- sharing a bed, clothes, towels, linen, or toiletries with unvaccinated people
The AMLC adds that it is not known whether the virus can spread to pets which could spread it further, and so contact with pets should also be avoided.
Furthermore,
If there is someone in your household who should not get the vaccine, such as a pregnant woman, an infant, or someone who has an illness, you should not stay in the house until the vaccination scab falls off. [emphasis added]
Virus, virus everywhere...
Leaving home for 6 weeks following inoculation isn’t going to be simple for a lot of people. But even after the scab has fallen off, the danger isn’t over.
Studies have found that the vaccinia virus can persist for months on various hard surfaces such as glass, steel, cinderblock, and carpet. One study, which involved milk infected with cowpox, showed that the virus persisted in cheese made from the milk even after the cheese had been ripening for 60 days. When the milk was heated to 65 degrees Celsius for 30 minutes, around 97% of virus was eliminated, but some viable particles remained.
Other studies have found both monkeypox and vaccinia virus particles in wastewater.
Californian women worry some
The FDA insists that ACAM2000 will not be freely available. Rather, it is being kept in the U.S. Strategic National Stockpile for the Department of Health and Human Services to distribute “in case it is ever needed.”
Currently, designated U.S. military personnel receive the vaccine. In addition, laboratory researchers working on certain pox viruses are also eligible to receive the vaccine.
The CDC also insists that ACAM2000 “has not been used in the current mpox outbreak that started in 2022,” and recommends using the Jynneos vaccine to protect against monkeypox.
It is clear, however, from VAERS reports that some people who are not at all at high risk for monkeypox (or smallpox) have received ACAM2000 over the past few years. To give a few examples from 2023:
- A 46-year-old woman from Maine suffered “permanent disability” after receiving ACAM2000 at a pharmacy.
- A 64-year-old woman from Connecticut also received the shot at a pharmacy and suffered mild adverse events.
- A 69-year-old woman from California was inoculated at a pharmacy and suffered a long list of adverse events including “loss of personal independence in daily activities ... memory impairment ... intense nerve pain ... weight loss.” This woman also experienced diarrhea following inoculation, presenting a greater danger of shedding. However, the VAERS report did at least note that, “She wears a mask as she does not want to challenge her respiratory [sic.] anymore.”
- A 62-year-old man from Kansas was inoculated using ACAM2000 and Grave’s Disease resulted, which was confirmed by laboratory results.
- A 66-year-old woman from California had a privately administered vaccine apparently with no serious after-effects.
Other VAERS reports include those of ACAM2000 being administered to people who clearly should not have been approved due to immune deficiency, including one person who is HIV-positive, another with “Long COVID,” and another with COPD (chronic obstructive pulmonary disease).
At least one report refers to someone getting the ACAM2000 and COVID shots together, which Emergent stresses should not occur.
And does it work? No one knows...
So much for the risks. What about the benefits? Are all these people at least protected from monkeypox?
According to one study, “Between 18 March and 15 May 2023, there was a cluster of 21 [monkeypox] cases in Chicago, 17 of whom were vaccinated (11 with 2 doses of JYNNEOS, 1 with ACAM2000, 5 with 1 dose of JYNNEOS)."
ACAM2000 was not specifically studied here — the reference is a side-note to a single case-study of viral mpox shedding.
But what about the clinical trial data, based on which ACAM2000 was approved?
From the FDA:
No clinical effectiveness study of ACAM2000 against mpox has been conducted...
