Monkey Business with the Pox Vaccine

Are we in for another demonstration of the Law of Unintended Consequences?

Following my editor’s advice, I front-loaded the hardcore science stuff today, with the rambling musings at the end, so you could decide which, if any, you might read.

The Law of Unintended Consequences has been on brilliant display throughout the Pandemic. The noble lie told early on, that regular people don’t need to wear masks, only healthcare providers working directly with COVID patients — had the unintended effects of: allowing people to rapidly spread the virus, seize upon this as a definitive pronouncement which was quite appealing, and finally generated deep distrust, when it later became clear that the extreme respiratory contagion of the virus was already known, and the recommendation was a paternalistic rouse to protect the limited mask supply. There are numerous other examples, and everyone may have their particular favorites. I think history will eventually show that the enforced closure of schools, especially in large urban centers, for periods exceeding a year, was one of the most damaging examples of the Law. This went on well past the time that one could say it was necessary to “flatten the curve” and prevent overwhelming of the healthcare system. The tragic results are becoming clear now in the huge loss of learning affecting a generation of American children, and hitting particularly hard amongst those at the lower end of the socio-economic ladder; the very ones with the least chance of recouping the loss. Factor in the tremendous negative impact on mental health, and the increase in drug use and suicide, and we see the Law at its ugliest. Let’s look at some very recent data on the Monkeypox vaccine and see if this alerts us to potential problems. A good thing to keep in mind is that there is zero clinical data on the effectiveness of Jynneous vaccine in preventing Monkeypox (or Smallpox for that matter) and effectiveness is inferred by measuring antibody levels. We also have no real idea what level of neutralizing antibodies are effective in preventing Monkeypox.

As is well known now, the CDC and the FDA decided to stretch the limited supply of Jynneous vaccine by giving 1/5 the approved dose by the intra-dermal, rather than subcutaneous route. There are vaccines which are effective when administered in this manner, but extensive testing is usually performed to establish that. In response to questions and criticism of this decision, Dr. Walensky and colleagues published a letter in the August 31st NEJM explaining their reasoning, and referencing a very limited literature pertinent to the issue. The only published paper I am aware of addressing the efficacy of intra-dermal Jynneos vaccine, is the following cited in their letter. Comparison of lyophilized versus liquid modified vaccinia Ankara (MVA) formulations and subcutaneous versus intradermal routes of administration in healthy vaccinia-naive subjects 10.1016/j.vaccine.2015.06.075 Vol 33, Issue 39 Pages Vol. 33 Issue 39 Page5225-5234

First of all, these researchers were measuring the ability of the vaccine to generate neutralizing antibodies against Smallpox, not Monkeypox. They found moderate to severe local reactions in 96% of patients receiving the intra-dermal group versus 58% in the subcutaneous group. More significantly (at least if you are not one of the test subjects) they found that 180 days after the second intra-dermal vaccine, only 35% of people had any detectable antibodies.

Let’s look at one more piece of unfortunate information, and tie this together with the intra-dermal story. The following preprint from the Netherlands was published last week and compares neutralizing antibody levels against Monkeypox and Smallpox generated by the Jynneous vaccine, which they refer to as MVA-BN.

Low levels of monkeypox virus neutralizing antibodies after MVA-BN vaccination in healthy individuals. medRxiv.org

The paper is a bit of a slog, looking at levels of Monkeypox antibodies in groups of people with recent Monkeypox (MPXV) infection, people who received the old Smallpox vaccine (VACV) many years ago (>50), and people vaccinated with the full dose of Jynneous (MVA-BN) vaccine.

We show that MPXV neutralizing antibodies were detected across all cohorts in individuals with MPXV exposure as well as those who received historic (VACV) vaccination. However, a primary MVA-BN immunization series in non-primed individuals (no history of old Smallpox vaccination) yields relatively low levels of MPXV neutralizing antibodies. As the role of MPXV neutralizing antibodies for protection against disease and transmissibility is currently unclear and no correlate of protection against MPXV infection has been identified yet, this raises the question how well vaccinated individuals are protected.

Small study to be sure, but they found the Jynneous vaccine to be effective in generating Smallpox neutralizing antibodies in all recipients, but only about 60% of people responded with Monkeypox antibodies at any level, and those were significantly lower than the Smallpox levels. We clearly need further study on how effective Jynneous vaccine (which is the focus of a massive vaccination campaign) truly is against the currently circulating strain of MPX. The virus has evolved genetic changes compared to the previously circulating African strains and antigenic differences are possible. Consider also that a major contributing factor to the approval of Jynneous vaccine were experiments in monkeys showing that the vaccine reduced mortality from a lethal dose of MPX — it did not produce sterilizing immunity and skin lesions still appeared. These monkeys were very likely contagious. So in summary, we have a vaccine with no clinical data on efficacy, being given in a reduced dose by a route, which in my mind at least, is not validated and questionable, and now there is evidence that perhaps this vaccine is very limited in its immunogenicity against the current world wide MPX strain. So what could go wrong?

The Pandemic is over, correct? Except in China where upwards of 60 million people are under lockdown now. In one city, they announced a three day lockdown. You know that Mr.COVID virus will chill for the weekend, streaming Netflix like the Andromeda Strain and Contagion, and getting Grubhub dim sum, then head back out to the sweat shops. On the vaccine front, China seems to have scooped the world this week with approval of the first inhaled COVID vaccine, the Adeno5nCOV from CanSino Biologics. This adeno-vector vaccine accounted for a small portion of the Chinese vaccination program, and it looks like they took the unused vaccine off the shelf, put it in a nebulizer and— voila! Perhaps they tested it on some prisoners and pregnant Uygher women (excuse me, birthing individuals).

I want to close this update with recognition of the new law passed in California, which punishes doctors (and nobody else), for disseminating misinformation about COVID. The Biden Administration Disinformation Governance Board was stillborn, or more exactly aborted postnatally. Into the breach step the brave lawyers, used car salesmen and tech entrepreneurs of the Golden State legislature to shield us from misinformation. Now I am seriously averse to misinformation and disinformation. The only question is, “Who is the Exalted Arbiter of Truth”, by which the denizens of the medical profession should be judged? Is it the CDC, which has been wrong many more times than recounted earlier here? We were told recently by the White House press secretary that “extremist” thought is that which deviates from the “majority of American’s thinking”. Just sounding the alarm here — but if that standard had been the norm in the past, we would all be thinking the earth was the center of the universe, and that some crazy German with Harpo Marx hair had once suggested that time was not invariant across all inertial frames of reference… before his license to practice physics was revoked. I proposed myself to be Grand Arbiter of the Faith, and I’m waiting patiently for Governor Newsom to respond.

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