Monkey Pox Vaccines – by Robert W Malone MD, MS
August 22, 2022
The Food and Drug Administration has already licensed two vaccines for monkeypox. Both were licensed a while ago, not in conjunction with this outbreak. The ACAM2000 and JYNNEOS vaccines are effective in combating smallpox, according to the FDA.
JYNNEOS (also known as Imvamune or Imvanex) is licensed (or approved) by the U.S. Food and Drug Administration (FDA) for the prevention of Monkeypox virusinfection, and
ACAM2000 is licensed (or approved) by FDA for use against Smallpox and made available for use against Monkeypox under an Expanded Access Investigational New Drug application.
For a summary of the recent White House press conference on Monkey Pox vaccines, please see the recent Epoch Times article: FDA Grants Emergency Use Authorization to Stretch Monkeypox Vaccine to Meet Demand
You can find a link to the recent amazingly bad press conference from the newly formed US Government White House Monkeypox Response Team here. After watching, I was left wondering if Bob Redfield is suffering neurological speech effects from COVID (or the mRNA vaccines).
This isnt the first time that there there has been an outbreak of Monkey pox in the USA.
But it was NOT in the context of this outbreak, that the current smallpox vaccines were tested and licensed against monkeypox. Nope - it took 20 years after this outbreak for the FDA to get around to licensure of the small pox vaccines for monkeypox. These vaccines were licensed in 2019. What a strange coincidence - that this happened two years before the current outbreak!
According to the U.S. Centers for Disease Control, there is notyet any data availableon the effectiveness of either vaccine in the current outbreak of monkeypox. But there is older data available from animal studies, clinical trials and studies in Africa.
Note: there have been no randomized clinical trials done, but lots of immunobridging type studies and an in the field trial by fire testing for post-exposure prophylaxis, or PEP of health care workers in Africa. Just like repurposed drugs and multi-drug, multi-stage treatments for COVID, there are studies that suggest efficacy. Which in this case, was plenty for the FDA to grant FULL licensure.
A number of clinical trials were done during the approval process for the Jynneos vaccine (one of the licensed products) show that ittriggers a strong antibody responsesimilar to the other small pox (ACAM2000) vaccine. Note that there has not been a randomized clinical CHALLENGE clinical trial - the gold standard. However, the CDC notes that an additional study done in nonhuman primates showed that vaccinated animals that were infected with monkeypox survived80% to 100% of the time, compared with zero to 40% survivalin unvaccinated animals.
Another use of the Jynneos vaccine is as apost-exposure prophylaxis, or PEP, as mentioned above. This means that the vaccine can help to decrease disease severity after exposure to the virus. According to the CDC, because the monkeypox virus incubates in a persons body for six to 14 days, a person who receives the Jynneos vaccine shortly after being exposedwill produce antibodies that can help fight off infection and protect against a serious monkeypox case.
The ACAM2000 data is older and less precise but shows strong protection against monkey pox. Researchers tested the vaccine during an outbreak of monkeypox in central Africa in the 1980s. Although the study was small and didnt directly test vaccine efficacy (ergo from a statistical standpoint, we dont know whether it worked or not), the authors concluded that unvaccinated people faced an85% higher risk of being infected than vaccinated people.
According to the CDC, prior smallpox vaccination does provide some protection against monkeypox, though thatprotection wanes over time. Experts advise that anyone who had thesmallpox vaccine more than three years agois at increased risk for monkeypox and should get the monkeypox vaccine.
There are no data on efficacy or effectiveness of either of these products as pre- or post-exposure prophylactics for the currently circulating Monkeypox virus, nor for Monkeypox infections acquired via transmission between men who have sex with men (MSM). Route of infection and infectious dose are critical parameters for evaluating efficacy of effectiveness of any vaccine product.
Dr. Meryl Nass has summarized key aspects of these products in her substack linked above.
1) there is no evidence to support using this vaccine in pregnancy, lactation or children. There is no information on male (as well as female) fertility effects or carcinogenicity.
2) About 2% of recipients had a serious adverse event
3) According to the label, between 1.3% and 2.1% of recipients had a cardiac event of special interest, compared to 0.2% of placebo subjects. According to the FDA review document, not mentioned in the label, there were 10% and 18% of subjects with troponin elevations in two sub-studies. This suggests that somewhere between 1 in 90 and 1 in 6 people will have a troponin elevation or EKG abnormality, indicating some degree of cardiac damage due to the shot.
4) The monkeypox virus against which the vaccine was tested is probably quite different from the monkeypox virus currently circulating.
5) Now, if you want a scarier picture of what the vaccine does to recipients, it is found in the FDA review of the documents and studies that led to Jynneos' 2019 license, but was not included in the label.
For example on page 191 of the FDA review: 8% of those subjects who were HIV positive could not get their second Jynneos dose due to side effects from the first. 7% of the HIV positive subjects had worsening of HIV parameters. It is likely that Jynneos causes immune suppression.
Thirty-eight SAEs [serious adverse events] were reported in HIV-infected subjects (17 vaccinia-nave, 6 vaccinia-experienced) and none in HIV-uninfected controls. Most of these fell under the Infectious or Respiratory SOCs. One of these SAEs, pneumonia which occurred 2 days after the 2nd dose of MVA-BN in a 39-year-old HIV-infected, vaccinia-nave woman, was considered possibly related to MVA-BN. [And the rest weren't, even though you withdrew the subjects from further doses?--Nass] Of note, 1.0% of HIV infected subjects (n=6) were withdrawn from the study due to AE and 7% (n=35) of HIV infected subjects did not receive a second dose of MVA-BN due to worsening of HIV parameters (drop in CD4 count or rise in HIV viral load) after the first dose.
The FDA label for the Jynneos product can be found here, and key points are listed below:
5.1 Severe Allergic Reactions
Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS.
The risk for a severe allergic reaction should be weighed against the risk for disease due to smallpox or monkeypox.
6. Adverse Reactions
Serious Adverse Events
SAEs were monitored from the day of the first study vaccinationthrough at least 6 months after the last study vaccination.
Among the smallpox vaccine-nave subjects, SAEs were reported for 1.5% of JYNNEOS recipients and 1.1% of placebo recipients. Among the smallpox vaccine-experienced subjects enrolled in studies without a placebo comparator, SAEs were reported for 2.3% of JYNNEOS recipients. Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 SAEs, all non-fatal, which included Crohns disease, sarcoidosis, extraocular muscle paresis and throat tightness.
Cardiac Adverse Events of Special Interest
Evaluation of cardiac adverse events of special interest (AESIs) included any cardiac signs or symptoms, ECG changes determined to be clinically significant, or troponin-I elevated above 2 times the upper limit of normal. In the 22 studies, subjects were monitored for cardiac-related signs or symptoms through at least 6 months after the last vaccination. The numbers of JYNNEOS and placebo recipients, respectively, with troponin-I data were: baseline level (6,376 and 1,203); level two weeks after first dose (6,279 and 1,166); level two weeks after second dose (1,683 and 193); unscheduled visit, including for clinical evaluation of suspected cardiac adverse events (500 and 60). [What happened to the rest of the people (about 70%) who should have gotten a second dose? Why are they missing followup visits?--Nass]
Cardiac AESIs were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients and 0.2% (3/1,206) of placebo recipients who were smallpox vaccine-nave. Cardiac AESIs were reported to occur in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced. The higher proportion of JYNNEOS recipients who experienced cardiac AESIs was driven by 28 cases of asymptomatic post-vaccination elevation of troponin-I in two studies: Study 5, which enrolled 482 HIV-infected subjects and 97 healthy subjects, and Study 6, which enrolled 350 subjects with atopic dermatitis and 282 healthy subjects. An additional 127 cases of asymptomatic post-vaccination elevation of troponin-I above the upper limit of normal but not above 2 times the upper limit of normal were documented in JYNNEOS recipients throughout the clinical development program, 124 of which occurred in Study 5 and Study 6. Proportions of subjects with troponin-I elevations were similar between healthy and HIV-infected subjects in Study 5 and between healthy and atopic dermatitis subjects in Study 6. A different troponin assay was used in these two studies compared to the other studies, and these two studies had no placebo controls. The clinical significance of these asymptomatic post-vaccination elevations of troponin-I is unknown. Among the cardiac AESIs reported, 6 cases (0.08%) were considered to be causally related to JYNNEOS vaccination and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations.
None of the cardiac AESIs considered causally related to study vaccination were considered serious. [I guess heart attacks and myocarditis no longer count as serious when there are $Billions at stake--Nass]
8.1 Pregnancy
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
8.2 Lactation
It is not known whether JYNNEOS is excreted in human milk. Data are not available to assess the effects of JYNNEOS in the breastfed infant or on milk production/excretion.
8.4 Pediatric Use
Safety and effectiveness of JYNNEOS have not been established in individuals less than 18 years of age.
11. DESCRIPTION
JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose is formulated to contain 0.5-3.95 x 10 to the 8th power infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7.
Each 0.5 mL dose may contain residual amounts of host-cell DNA ( 20 mcg), protein ( 500 mcg), benzonase ( 0.0025 mcg), gentamicin ( 0.163 mcg) and ciprofloxacin ( 0.005 mcg).
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
JYNNEOS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.
13.2 Animal Toxicology and/or Pharmacology
The efficacy of JYNNEOS to protect cynomolgus macaques (Macaca fascicularis) against a monkeypox virus (MPXV) challenge was evaluated in several studies. Animals were administered Tris-Buffered Saline (placebo) or JYNNEOS (1 x 108 TCID50 ) sub-cutaneously on day 0 and day 28.
On day 63, animals were challenged with MPXV delivered by aerosol (3 x 105 pfu), intravenous (5 x 107 pfu) or intratracheal (5 x 106 pfu) route. Across all studies, 80-100% of JYNNEOS-vaccinated animals survived compared to 0-40% of control animals
Meryl makes a key point regarding the non-human primate studies:
[Hang on, the monkeypox virus against which the Jynneos vaccine was tested killed 60-100% of the unvaccinated monkeys. But the currently circulating monkeypox virus has not killed a single American and causes a mild, self-limited disease according to the CDC. Seems like this vaccine was tested against a very different virus. Does it work against the current strain?--Nass]
Regarding the other Monkey Pox vaccine that is actually a smallpox vaccine. Further observations from Dr. Meryl Nass:
ACAM2000 caused 1 in 220 never previously vaccinated recipients to get myocarditis or pericarditis, and over 3% (1 in 30) to have elevated troponin, in a well done military study in over 1000 vaccinated soldiers. But Jynneos could conceivably cause a lot more myocarditis, if the 2 studies that showed troponin elevations in 11-18% of recipients hold up.
Here's the bottom line:
there is no evidence from any studies that either vaccine prevents moneypox in humans
the current moneypox outbreak causes a febrile, flu-like illness followed by rash, then resolves. It is mild. Mortality figures have been way overblown, since no one has died n a western country. The disease seems roughly equivalent to shingles.
either vaccine may cause very serious heart damage, much more commonly than COVID vaccines do, based on available evidence, so the risk from the vaccines far exceeds any potential benefit they might convey.
the odds so far are that moneypox came from a lab and was deliberately spread.
Both moneypox and shingles spread via the release of viral particles from the fluid in blisters, aka pocks. Casual spread is rare.
FDA and CDC are probably excited that they will finally get some real data in humans to justify their approval of the smallpox vaccine boondoggles.
Given the risks of adverse events, cost and logistical considerations associated with smallpox vaccination, alternate strategies should also be considered for control of human MPX. An alternative to vaccination could be treatment of incident cases with antiviral therapy to reduce the morbidity and transmission, and by providing access to antibiotics for treatment of secondary bacterial infections. Clinical diagnosis of MPX is relatively easy, thus effective antivirals and supportive clinical care may be more practical options than vaccination at this time.
Reducing the frequency of human MPX infection could be also be accomplished through health education on handling potential animal reservoir species to prevent animal-to-human transmission and by quarantine or contact isolation to prevent human-to-human spread. Defining the factors underlying increased incidence, and their impact on primary versus secondary transmission, is thus a crucial direction for on-going research. Additionally, a better understanding of the mortality and complications associated with monkeypox infection should be assessed. Continued active disease surveillance in endemic regions coupled with household and contact studies with long term follow up would address these important questions.
Further studies are also needed to identify intermediate hosts and animal reservoirs. Smallpox vaccination will not modify the reservoir nor the amount of MPX virus found in amplification species. Introduction of MPX into human populations is dependent upon contact with infected species, thus vaccination alone will not be effective in controlling the geographic spread of MPX as it is determined by the movement of animals and driven largely by the loss of natural habitat.
Most monkeypox cases resolve with only the use of over-the-counter medications for symptomatic care. However, more severe cases can be treated with an antiviral medication called Tecovirimat or TPOXX, which is available through the US stockpile.
Although this medication is available, it is not directly approved for monkeypox. Tecovirimat was approved in 2018 for the treatment of smallpox in adults and children but it has not been directly studied in monkeypox. Clinical trials of animals have shown that there is some efficacy in treating all diseases caused by orthopoxviruses, which includes monkeypox.
Several physicians have reported that getting this medication can be difficult as they had to go through a lengthy process to obtain it from the US Stockpile for their patients.
The administrative and bureaucratic issues surrounding giving tecovirimat are substantial and many clinicians struggle with getting this medication, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Tennessee.
The CDC has given guidance to those who qualify for this medication including those with severe illnesses.
Currently tecovirimat is only available from a CDC-sponsored expanded access program for patients at high risk for complications those that are immunocompromised, pregnant, and children under eight or those with severe disease such as lesions in the eye, mouth, or anogenital areas, disseminated lesions, or encephalitis, said Dr. Roy Gulick, Chief of the Division of Infectious Diseases at the Weill Medical College of Cornell University.
Another medication called Brincidofovir, or CMX001, has similarly been approved for the treatment of smallpox, and the CDC is currently creating a protocol to use it for monkeypox but can be more toxic to individuals taking the medication.
Despite the potential promise of these medications, they are still not readily available to all physicians and pharmacies.
The primary option for treatment is Tecovirimat which is not readily available in hospitals or pharmacies and must be obtained through a specialist working closely with the health department or CDC, explained Dr. Jeremey Walker, assistant professor at the University of Alabama at Birmingham Division of Infectious Diseases.
In the context of the current outbreak, Monkeypox is for all intent and purposes a STD.
As such, the risk of contracting a STD is depending on lifestyle choices. Ergo - if people change their lifestyle, even for a month - this epidemic could be halted in its tracks. Yet, in reading the CDC and Whitehouse literature, at no point does it advise people to consider abstinence. Nor is there a recommendation that if they suspect monkeypox they should notify their physician immediately with names and numbers of sex partners. Ergo: contact tracing. No discussion of some sort of self-quarantine.
This is a tried and true methods of ending infectious STD outbreaks such as this one. That this method of public health control is not being advertised and acted on is shocking. This implies regulatory capture by interest groups.
This is not a time to be squeamish or politically correct. If we do not want to see Monkeypox join the ranks of Chlamydia, Gonorrhea, Syphilis, Mycoplasma Genitalium (MG), Human Papilloma Virus (HPV), Crabs / Pubic Lice, Herpes or Hepatitis B/HBV, the US government has to do more than offer vaccines to high risk individuals.
The rest is here:
Monkey Pox Vaccines - by Robert W Malone MD, MS
