MPox vaccines that shed and other lessons regulatory and public health authorities just won't learn
When regulatory agencies repeatedly fail to learn from mistakes, we need to consider the possibility that they’re not mistakes. And then we need to think about what public health authorities are really doing…
Mpox is currently looking like the winner of the Pandemic Olympics. It’s symptoms are ugly and obvious and can serve as the perfect decoy for cases of shingles and other skin conditions that have surfaced in the wake of autoimmune and immune deficiency illness following mass Covid vaccination. But it needs to be scarier.
Enter testing. Positive tests can be used to convince (some) people that you can be sick and dangerous without any symptoms at all while “presumptive cases” inflate numbers to convince us that it’s EVERYWHERE.
The hope is that, once people are afraid enough, they’ll agree to take a fast-tracked emergency shot… or even an existing shot that has a terrible track record. And sheds.
It’s pretty clear that variations of the same playbook will continue to play out until we stop playing along. Can we please stop playing along?
Asymptomatic Mpox
The asymptomatic Mpox narrative is making rounds and stoking fear…
(“It’s possible”… “might be able to”.… Always watch for the qualifiers.)
From the 2022 Today Show article about a study from 2022:
An analysis of previously collected anal swabs from men who had sex with men and had no monkeypox symptoms revealed that 6.5% were positive for the virus…
To explore whether people could have asymptomatic monkeypox, Ghosn and his colleagues turned to swabs that had been collected earlier at their center as part of a screening program for gonorrhea and chlamydia in men had reported having multiple sexual partners and who were getting medication to prevent AIDS or to prevent infection with HIV.
The researchers examined only swabs from men who had tested negative for the two STDs, who did not show any lesions during exams by healthcare personnel and who had not reported any signs or symptoms of monkeypox. Of the 200 swabs that were testable for monkeypox, 13 were positive for the virus.
“Whether they might transmit the disease to someone else is not something we tested for,” Ghosn said.
You can read the full article here.
So we’re still testing (and now repurposing used anal swabs) as public health resurrects fear of asymptomatic disease spread.
Vaccines, of course
The CDC has listed two vaccines that “may be used for the prevention of mpox.” One of them sheds and has a horrible track record. The other one was approved based on a clinical trial that used the first/shedding vaccine as a comparator.
The CDC seems to have a problem learning two key things (among others):
Shedding vaccines are a bad idea (as they can spread disease).
Using other vaccines as “placebo comparators” also a bad idea (as they skew the risk profile).
So here we are. According to the CDC:
Two vaccines may be used for the prevention of mpox:
JYNNEOS vaccine is approved and recommended by CDC and ACIP for the prevention of mpox and smallpox. During the ongoing clade II MPXV outbreak (i.e., outbreak that began in 2022 affecting predominantly gay, bisexual, and other men who have sex with men), JYNNEOS has been the main vaccine used in the United States.
ACAM2000 vaccine is approved for immunization against smallpox and could be made available for use against mpox under an Expanded Access Investigational New Drug (EA-IND) protocol. In the United States, there is a large supply of ACAM2000, but this vaccine has more known side effects and contraindications. (emphasis mine)
Since FDA approval of JYNNEOS relied on a clinical trial that compared it to ACAM2000, let’s first look at ACAM2000.
ACAM2000
As stated earlier, the US has a large supply of ACAM2000, which has been approved for smallpox, but “could be made available for use against mpox under an Expanded Access Investigational New Drug (EA-IND) protocol.” We need to be vigilant about this. Here’s why…
Page one from the package insert is telling.
ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee and the risks in contacts are the same as those stated for vaccinees. (emphasis mine)
What are those risks??
Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome) and eczema vaccinatum. Severe disability, permanent neurological sequelae, and/or death may occur. Death of unvaccinated individuals who have contact with vaccinated individuals. [See Warnings and Precautions (5.1)]. • Myocarditis and/or pericarditis, ischemic heart disease and nonischemic, dilated cardiomyopathy [See Warnings and Precautions (5.1)]. • Ocular complications and blindness [See Warnings and Precautions (5.3)].
Inadvertent inoculation at other body sites is the most frequent complication of vaccinia vaccination, usually resulting from autoinoculation of the vaccine virus transferred from the site of vaccination. The most common sites involved are the face, nose, mouth, lips, genitalia and anus. Accidental infection of the eye (ocular vaccinia) may result in ocular complications including, but not limited to, keratitis, corneal scarring and blindness.
Inadvertent inoculation (aka spreading of vaccine virus) is a frequent complication because of how the vaccine “works”.
The primary determinant for an effective immune response in those naïve to vaccine is a major cutaneous reaction. ACAM2000 was non-inferior to comparator in this population with regard to eliciting a major cutaneous reaction.
In an individual vaccinated for the first time (primary vaccination), the expected response to vaccination is the development of a major cutaneous reaction (characterized by a pustule) at the site of inoculation. The lesion evolves gradually, with appearance of a papule at the site of vaccination after 2-5 days. The papule becomes vesicular, then pustular, and reaches its maximum size at 8-10 days after vaccination. The pustule dries and forms a scab, which usually separates within 14-21 days, leaving a pitted scar. (See Figure 1) Formation of a major cutaneous reaction by day 6-8 is evidence of a successful ‘take’ and acquisition of protective immunity. An equivocal reaction is any reaction that is not a major reaction, and indicates a non-take (vaccination failure) due to impotent vaccine or inadequate vaccination technique. (emphasis mine)
So ACAM 2000 - which is “non-inferior” to the Dryvax vaccine that was discontinued in 1982 - demonstrates it’s efficacy by producing lesions and fluid-producing pustules that can spread vaccine virus. The package insert has detailed instructions about how to carefully clean, dry and dress the vaccination site for up to 21 days and deal with contaminated materials that may have touched the site until your “pitted scar” appears. (Now consider the potential impact of sending 50,000 doses of this to the Democratic Republic of Congo - see below.)
But you are reminded that, if you have a terrible reaction, it likely could have been worse…
Persons at greatest risk of experiencing serious vaccination complications are often those at greatest risk for death from smallpox.
Why would anyone want a vaccine that could actually infect them, cause serious and life-threatening side effects and potentially subject people around them to the same?
Given the risks to both vaccinees and the people around them, why would our government agencies would ever even consider giving them to us? Maybe because they’re already bought and paid for. In 2019, HHS made a $2 billion + deal with Emergent Biosolutions to continue supplying ACAM 2000 to the national stockpile.
In a nod to modern “philanthropy” (or philanthropathy, as Margaret Anna Alice would say), ACAM2000 maker, Emergent BioSolutions is donating the shedding vaccine to a humanitarian relief organization in the Democratic Republic of Congo.
Emergent BioSolutions announced in August 2024 that it is “proactively” working with WHO and the US government in response to the outbreak of mpox in Africa and has pledged to donate 50,000 doses of ACAM2000. The donation will be delivered with Direct Relief, a humanitarian relief organisation that has a “long history” of providing medical interventions to the Democratic Republic of the Congo (DRC) and other affected countries.
ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) is the primary smallpox vaccine designated for use in a “bioterrorism emergency”. Doses have been supplied to the US Strategic National Stockpile. It is indicated for active immunisation against smallpox disease for persons determined to be at high risk for infection. It is a single-dose vaccine administered via a bifurcated needle.
Emergent filed a supplemental Biologics License Application (sBLA) to the US FDA in 2023 to seek an expanded indication for ACAM2000 vaccine to include immunisation against mpox virus. This application includes human safety data and animal study data showing that ACAM2000 was effective in protecting against mpox virus exposure. Emergent has also responded to WHO’s invitation for an Expression of Interest for Emergency Use Listing.
It looks like those vaccines will also being going to Burundi, Kenya, Rwanda, Uganda, and other countries.
Sounds familiar. Everbo, Merck’s shedding Ebola vaccine, was used during the last big Ebola outbreak in Congo under “compassionate use” before it was approved. Medical apartheid in “compassionate” disguise. At some point we really need to be looking at the countries we regularly use to test vaccines to determine whether they solve problems or perpetuate them.
JYNNEOS
From a 2019 FDA press release:
The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection…
Jynneos does not contain the viruses that cause smallpox or monkeypox. It is made from a vaccinia virus, a virus that is closely related to, but less harmful than, variola or monkeypox viruses and can protect against both of these diseases. Jynneos contains a modified form of the vaccinia virus called Modified Vaccinia Ankara, which does not cause disease in humans and is non-replicating, meaning it cannot reproduce in human cells.
So Jynneos is not known to shed (although we’ve heard assertions like this before and many of the people who developed Mpox in the US were vaccinated with Jynneos). But there are a lot of leaps here.
First, Jynneos was studied in comparison to ACAM2000. Second, vaccine effectiveness was “inferred.”
The effectiveness of Jynneos for the prevention of smallpox was determined in a clinical study comparing the immune responses in study participants who received either Jynneos or ACAM2000, an FDA-approved vaccine for the prevention of smallpox. The study included approximately 400 healthy adults, 18 through 42 years of age who had never been vaccinated for smallpox, in which half of the study participants received two doses of Jynneos administered 28 days apart, and half received one dose of ACAM2000. The group vaccinated with Jynneos had an immune response that was not inferior to immune responses to ACAM2000. Vaccine effectiveness for the prevention of smallpox was also inferred from supportive animal studies that showed prior vaccination with Jynneos protected non-human primates who were exposed to viruses related to the smallpox virus…
The effectiveness of Jynneos for the prevention of monkeypox disease is inferred from the antibody responses in the smallpox clinical study participants and from studies in non-human primates that showed protection of animals vaccinated with Jynneos who were exposed to the monkeypox virus.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-live-non-replicating-vaccine-prevent-smallpox-and-monkeypox
In August 2022 an EUA was issued for Jynneos “however, real-world effectiveness data are limited.” A more recent CDC-funded study claims the “estimated adjusted effectiveness” for 2 doses of the vaccine is 66%.
Meanwhile, is anyone surprised that we’ve been doing gain-of-function research on Mpox?
For nearly nine years Dr. Anthony Fauci’s institute concealed plans to engineer a pandemic capable mpox, formerly known as monkeypox, virus with a case fatality rate of up to 15%, congressional investigators revealed in a new report on June 11.
In June 2015, a scientist at the National Institute of Allergy and Infectious Diseases (NIAID) received formal approval from the National Institutes of Health’s (NIH) Institutional Review Board for experiments expected to engineer a mpox virus with high transmissibility and moderate mortality…
A new interim report describes the obstruction and secrecy around the mpox proposal as a case study of how the institute “oversees and accounts for the monitoring of potentially dangerous gain-of-function research of concern.”
The revelations land amid global concerns about whether coronavirus gain-of-function research — research that might generate pathogens with increased pathogenicity or transmissibility — may have contributed to the worst pandemic in a century.
The committee, in conjunction with the House Committee on Oversight and Reform, is also investigating coronavirus gain-of-function research underwritten by NIAID at the Wuhan Institute of Virology, and faces similar stonewalling in that investigation, a committee aide said.
Or that Dr. Bertrand Moss, the NIAID scientist who did this research also helped create the vaccine? From Wikipedia:
Most importantly, he developed a technology for exploiting the vaccinia virus as a mechanism for developing novel vaccines.
You can check out the patents based on his research (many of which the CDC and NIH hold) here.
Does anyone else find it troubling that the same people who seeded the Mpox narrative and may have contributed to the spread and amplification of Mpox have also helped to provide the “solution”?
You are very likely correct. They are not our friends, whatever loyalty and concern that they have for us, is because of the milk of human kindness (which COVID pretty clearly dried up and spoiled.) and not because of any institutional incentives or orientation to individual citizens (we are n to their patients.
More crudely, we are of of interest to them only so far as we comply with their injections, many of them want us Dead whether or not we take the jabs. Whether for jab benchmarks, financial incentives, personal ego, or personal, professional, or political animus, they couldn't care less about us.
The thing to look for would be to see if there's an uptick of people with skin issues, since the rollout of the COVID-19 diseases -- before all the monkey pox nonsense fired up.
I would assume there would be. I just haven't looked into it yet.
The only thing that strikes me as odd about the whole monkey pox bit, is that they were just saying how it was not really an issue, then they flip the script, and now it's a big issue again.
You would imagine that "the science" would be questioned by more people when they keep going back and forth with all of this. Just like Fauci with the masks. You don't need them, then you do, now you need two! It's just stupid at this point.