Where did Money Pock$ come from?

What a coincidence that FDA approved a sketchy monkeypox vaccine in 2019.

There are now 2500 moneypox cases diagnosed in the current outbreak, in over 40 countries, and not a single death that anyone can point to, outside of Africa. Maybe ever. One moneypox death is said to have occurred this year in Nigeria, a country of 206 million people, but without any confirmatory details.  I think the authorities have been desperate to locate a death.

Only CDC can confirm a case, which means CDC has the ability to decide how many US cases there are.

Canada offered vaccine to high risk men who have sex with men last week, and the UK is doing so now, as reported by the AP on June 21. On June 22, the criteria for vaccinating have already expanded, per today’s Stat:

Yesterday, British authorities recommended taking their monkeypox-fighting tactics one step further: Instead of offering vaccines only to close contacts of those diagnosed with the virus, they suggested broadening the eligibility to anyone at increased risk of exposure. The criteria would be similar to those for pre-exposure prophylaxis against HIV, and might include, for instance, men who have sex with men and who have several partners. 

This virus has never spread like this before.  I don't think a rave or two can explain how it suddenly appeared in 20 countries on 4 continents at once.  The simultaneous nature of widespread cases, and apparent increased human-to-human transmission suggest it was spread deliberately and may have been engineered.

The initial full genome sequence, performed in Portugal, revealed the current strain most closely matched a strain that had been identified in 2018 and 2019 in Israel, the UK and Singapore.  This is suggestive of lab origin, but not definitive proof.  Hopefully there are some honest virologists who will continue to study the genome, and more will become clear with time.  Hopefully Tony Fauci and Jeremy Farrar have not organized yet another coverup of the origins of the moneypox strain. 

Why MONEYPOX??  Could it be because there is a vaccine?

• Doesn't anyone else think it odd that this virus just happens to be susceptible (so they claim) to a vaccine that the US Government has stockpiled?

• Doesn't anyone else think it is odd that the FDA approved (licensed) a vaccine for moneypox named Jynneos in 2019, when there had only been about 50 human cases diagnosed in the US, cumulatively, during the past 60 years?  

• Why license a vaccine for a rare disease that almost nobody dies from?  

• Why license the vaccine for moneypox when it was never tested to see if it prevented moneypox in humans?  

It is hard to believe that FDA gave this vaccine a license when you read the FDA reviewers' comments in their own report, below.  They could not test the vaccine for efficacy against smallpox because there is no smallpox, nor against monkeypox because the disease is so rare.  So the FDA relied on neutralizing antibody titers.  But at the same time, FDA admitted there is no established correlate of protection.  This means that there is no evidence that the titers represent actual immunity to infection.  So FDA relied on animal studies to simply guess the vaccine might be effective in humans.

Furthermore, there is very strong suggestive evidence of cardiac damage/myocarditis, which is a well known side effect of other smallpox vaccines. CDC admitted as recently as last November that 5.7 people per thousand recipients (1 person for each 175 recipients) got myocarditis from the ACAM2000 vaccine, the other US-licensed smallpox vaccine.  But FDA acted blind, deaf and dumb about this obvious, serious risk:

Since only one effectiveness study with an active comparator (POX-MVA-006) exists, and vaccinia specific neutralizing antibody titers determined by PRNT vary greatly across studies, we concurred with the applicant that an integrated summary of efficacy (ISE) is not required. p. 23

... Reviewer’s comment: Contrary to the title, the study did not examine efficacy of the vaccine with a clinical endpoint but instead evaluated immunogenicity and take attenuation and no correlation of protection exists. p. 30

Vaccinia specific neutralizing antibody titers among vaccinia-naïve subjects dropped quickly following primary MVA-BN vaccination series. The antibody titer peaked at 2 weeks after the last dose of primary vaccination (GMT 46) and was almost undetectable at 6 months after the last dose of primary vaccination with a GMT of 7 (assay LLOD ≥6). A single dose of MVA-BN at 2 years after the primary vaccination with MVA- BN induced a booster antibody response. However, the neutralizing antibody titer dropped from a peak GMT of 125 at two weeks after the booster dose to 49 at 6 months after the booster dose. No data were available beyond 6 months after the booster dose. It appears that there may be a need for a booster dose after the primary MVA-BN vaccination. p. 196

Up to 18.4% of subjects in 2 studies developed post-vaccination elevation of troponin [a cardiac muscle enzyme signifying cardiac damage--Nass]. However, all of these troponin elevations were asymptomatic and without a clinically associated event or other sign of myopericarditis. p. 198

The applicant has committed to conduct an observational, post-marketing study as part of their routine PVP. The sponsor will collect data on cardiac events that  occur and are assessed as a routine part of medical care. p. 200

This suggests that all those men who receive the vaccine now will be the guinea pigs, the first humans to determine if there is protection, and what the risks may be. Gay and bisexual men in their 20s and 30s will probably be at the highest risk of myocarditis, since males in this age group are at the highest risk of myocarditis from COVID mRNA vaccines.

It is they in whom it will be determined whether elevated cardiac enzymes, seen in two trials in up to 1 in 5 Jynneos vaccine recipients, are associated with cases of myocarditis, pericarditis, hart failure, arrhythmias or heart attacks. Then again, assuming FDA and CDC follow the COVID playbook, this serious side effect is likely to get missed, and sudden deaths in recipients may simply be brushed under the rug.

OTOH, if 1 in 5 recipients gets cardiac inflammation, it may be impossible to airbrush it away.

Let me ask again:  WHY moneypox?  Here are some reasonable possibilities:

•To induce fear as anxiety about COVID is resolving? 

•To reduce sexual activity and encourage physical distancing?

•To push more vaccines on the public?

•To financially benefit politically connected biodefense companies?

•To use up a boondoggle and replenish the smallpox vaccine stocks?

There are two vaccines that FDA has licensed for smallpox in recent years.  The US government bought about 290 million doses of ACAM2000 and over 10 million doses of Jynneos, although now CDC will only say there are 100 million doses in the national stockpile.  The US government has ongoing contracts for more ACAM2000 smallpox vaccine.

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:

a) there is no evidence from any studies that either vaccine prevents moneypox in humans 

b) 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.

c) 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.

d) the odds so far are that moneypox came from a lab and was deliberately spread.

e) Both moneypox and shingles spread via the release of viral particles from the fluid in blisters, aka pocks. Casual spread is rare.

f) 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.

Remember what the WHO so presciently sang:  "Don't Get Fooled Again!"   Please stay safe.