Executive Summary

Why rushing a vaccine trial injects all sorts of risks into the equation
Weighing these risks vs the risks of not getting the vaccine
Others cautions to be aware of
My personal plans for the vaccine

If you have not yet read Part 1: Prive Profits Vs Public Health, available free to all readers, please click here to read it first.

You’ve all heard the news; the new vaccines were produced in a miraculously short time and are miraculously effective (90%+).

I remain both slightly skeptical and cautiously optimistic.

I am not anti-vaccine by any stretch. I have been well vaccinated in my life, and I continue to get tetanus boosters. But I am becoming increasingly ‘vaccine cautious’ as I learn more and more, especially from ER doc user ‘SandPuppy’ here at the site.

Covid has taught me a lot about viruses and our immune systems. Both are ridiculously complex and locked into a battle that is as gripping as it is subtle. Viruses may well be math geniuses. They play the law of large numbers and by trying new things, iterating, and refining, they evade and commandeer the very systems designed to detect and destroy them.

Consider that Sars-CoV-2 not only manages to invade a cell and replicate, but turns on and off a huge array of genes located in the cell nucleus and thereby commandeering the larger set of regulatory systems at the whole body level.

This is the “Bradykinin Hypothesis.” Everything in red (below, screenshot from Sept 3^rd YouTube video) is a gene system that is turned off or ‘downregulated’ and everything in blue is turned on or upregulated.

In other words, everything the virus needs to spread and replicate more widely is amplified and things that might interfere with those plans are dialed down or turned right off.

It’s mad genius I tell you!

It also makes a big mess in our bodies.

The point here is that our immune systems are ridiculously complex. When we introduce vaccines what we’re doing is consciously interacting with something that we really just don’t understand all that well and certainly cannot predict.

Which is why vaccine trials are among the longest and most complex to run. Well, they used to be. These current vaccines are being fast-tracked and many usual steps are being skipped in the interest of time.

For example, nobody can answer the question “what sorts of things do we find in vaccinated people at the 12-month mark?” because 12 months hasn’t yet passed. Ordinarily such surveillance is a typical and usual part of vaccine development not only because you want to scan carefully for any down-stream reactions, but you’d like to know if the vaccine remains effective.

By The Numbers

You’ve definitely heard the news; the Pfizer vaccine is 95% effective! Moderna’s is also 95% effective!

But what do these numbers mean?

Some quick math reveals much. Pfizer’s trials enrolled 43,661 patients and was analyzed once 170 cases of Covid were detected. That is, the study seals were broken and those who’d had the vaccine were known to researchers as were the controls.

162 of the Covid ‘cases’ were in the placebo control group and the remaining 8 were in the vaccine group. That yields the “95% effective” figure (162/170 = 0.953).

However, this is an unusual way to calculate things. This is the ‘relative risk’ which answers the questions “what are my chances of getting sick as compared to the treated group?”

The more normal way of calculating this would be by the absolute risk which would answer the question “what’s my chance of getting sick overall?”

For the placebo group that was (164/43,661/2) = 0.19% (or a 99.81% chance of not catching Covid during the study period)

For the vaccine group that was (8/43,661/2) = 0.01% (or a 99.99% chance of not catching Covid during the study period)

So, on an absolute risk basis the placebo control group has an 0.18% greater chance of contracting Covid than the vaccine group.

What we still don’t know is what constituted a ‘case’ to them. There’s nothing in the minimal information released yet to indicate what this meant. Detected via PCR? If so at what cycle threshold? We don’t know.

Again, none of these people were offered hydroxychloroquine or ivermectin, which breaches many ethical barriers as far as I am concerned.

Further there was no information offered on the severity of the ‘cases’ and hospitalizations and deaths were not endpoints so we don’t know what, if any, effect the vaccine will have on those parameters. Nor do we know if vaccination people will still spread the disease or not, or how long the vaccine might last in terms of effectiveness.

It is against this veritable see of unknowns that we have to weigh the risks of getting the vaccine vs not getting it.

Gilbert Berdine, as associate professor of medicine wrote about how all this uncertainty is playing out among some medical professionals:

There is no information about [mRNA] safety. None. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers. I am employed by a university-based medical center that is a referral center for the West Texas region.

My colleagues include resident physicians and faculty physicians who work with covid patients on a daily basis. I have asked a number of my colleagues whether they will be first in line for the new vaccine. I have yet to hear any of my colleagues respond affirmatively. The reasons for hesitancy are that the uncertainties about safety exceed what they perceive to be a small benefit. In other words, my colleagues would prefer to take their chances with covid rather than beta test the vaccine.

Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.

These announcements by Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harm of covid-19. I certainly hope that these vaccines are safe. If both of these conditions are true, nobody will need to be coerced into taking the vaccine. However, you should pay even more attention about what is left out of an announcement than about what is stated.

The pharmaceutical companies are more than happy for patients to misunderstand what is meant by efficacy. Caveat emptor (buyer beware)!

(Source)

I’m in complete agreement. Wait a year, if you can. See how this all plays out. Let others raise their hands to be beta testers.

Or trust the same companies that have acted to suppress Ivermectin data will have your best interests at heart this time.

Other Notes of Caution

Where The Lancet and the NEJM of thoroughly embarrassed themselves by their potent advocacy for Pharma advertising masquerading as “science” this year (even going so far as to run completely fraudulent “studies” by Surgisphere) The BMJ now stands out as a journal with some integrity left.

Peter Doshi is associate editor there and he penned a quite thoughtful piece on the mRNA vaccines on November 27^th that deserves more attention:

(…)

Most crucially, we need data-driven assurances that the studies were not inadvertently unblinded, by which I mean investigators or volunteers could make reasonable guesses as to which group they were in. Blinding is most important when measuring subjective endpoints like symptomatic covid-19, and differences in post-injection side-effects between vaccine and placebo might have allowed for educated guessing. Past placebo-controlled trials of influenza vaccine were not able to fully maintain blinding of vaccine status, and the recent “half dose” mishap in the Oxford covid-19 vaccine trial was apparently only noticed because of milder-than-expected side-effects. (And that is just one of many concerns with the Oxford trial.)

In contrast to a normal saline placebo, early phase trials suggested that systemic and local adverse events are common in those receiving vaccine. In one Pfizer trial, for example, more than half of the vaccinated participants experienced headache, muscle pain and chills—but the early phase trials were small, with large margins of error around the data. Few details from the large phase 3 studies have been released thus far. Moderna’s press release states that 9% experienced grade 3 myalgia and 10% grade 3 fatigue; Pfizer’s statement reported 3.8% experienced grade 3 fatigue and 2% grade 3 headache. Grade 3 adverse events are considered severe, defined as preventing daily activity. Mild and moderate severity reactions are bound to be far more common.

One way the trial’s raw data could facilitate an informed judgment as to whether any potential unblinding might have affected the results is by analyzing how often people with symptoms of covid-19 were referred for confirmatory SARS-CoV-2 testing. Without a referral for testing, a suspected covid-19 case could not become a confirmed covid-19 case, and thus is a crucial step in order to be counted as a primary event: lab-confirmed, symptomatic covid-19. Because some of the adverse reactions to the vaccine are themselves also symptoms of covid-19 (e.g. fever, muscle pain), one might expect a far larger proportion of people receiving vaccine to have been swabbed and tested for SARS-CoV-2 than those receiving placebo.

This assumes all people with symptoms would be tested, as one might expect would be the case. However the trial protocols for Moderna and Pfizer’s studies contain explicit language instructing investigators to use their clinical judgment to decide whether to refer people for testing. Moderna puts it this way:

“It is important to note that some of the symptoms of COVID-19 overlap with solicited systemic ARs that are expected after vaccination with mRNA-1273 (eg, myalgia, headache, fever, and chills). During the first 7 days after vaccination, when these solicited ARs are common, Investigators should use their clinical judgement to decide if an NP swab should be collected.”

This amounts to asking investigators to make guesses as to which intervention group patients were in. But when the disease and the vaccine side-effects overlap, how is a clinician to judge the cause without a test? And why were they asked, anyway?

Importantly, the instructions only refer to the first seven days following vaccination, leaving unclear what role clinician judgment could play in the key days afterward, when cases of covid-19 could begin counting towards the primary endpoint. (For Pfizer, 7 days after the 2nd dose. For Moderna, 14 days.)

In a proper trial, all cases of covid-19 should have been recorded, no matter which arm of the trial the case occurred in. (In epidemiology terms, there should be no ascertainment bias, or differential measurement error). It’s even become common sense in the Covid era: “test, test, test.” But if referrals for testing were not provided to all individuals with symptoms of covid-19—for example because an assumption was made that the symptoms were due to side-effects of the vaccine—cases could go uncounted.

(Source)

This is just a small sampling of the legitimate questions that need to be answered and in underscores just how tricky it is to pull off a large trial correctly.

Without knowing what actually constituted a ‘case’ or, as Peter points out above, even how it was that people were selected to go off for a follow up test for Covid (leaving open the large chance for bias), we’re left with the impression that we’d much rather wait for the full study data to be peer reviewed and released before accepting a jab.

A Personal Story

Because we’re safely behind the paywall I can tell you this. I have personally taken Ivermectin, not once but twice. Horse paste both times, 600 mg of paste each time.

The first time was back in March after I’d been suffering from very weird and painful lung sensations (like pleurisy), was feeling crappy, and thought there was a chance I had somehow caught Covid. I took Druvet horse paste – it’s greasy, like apple-flavored petroleum jelly – along with doxycycline and extra zinc.

Within 48 hours I was feeling fine. I have yet to have a Covid test so I can’t be sure of anything. All I can say is I’ve never quite felt a lung sensation like that before or since, and I recovered quickly after the Ivermectin experiment.

The second time was just two weeks ago. I’ve been under a lot of stress of late. My eldest daughter, Erica, just 26 and otherwise the very picture of health, was diagnosed with stage 4 Hodgkin’s. I was in a mad scramble for weeks to learn everything I could, phoning doctors and centers, helping to assemble a team and a treatment regimen, and otherwise in a definite psychological tunnel filled with emotions.

The good news is that Erica’s treatment is about to begin, she’s got a great team assembled, and at least we know the path she’s on. How it turns out remains to be seen. However, even though she’s stage 4, her prognosis is good due to her health, age, and other factors. Still – a huge shock for her. And for me.

The bad news is that at the end of all that I came down with shingles. Ugh! Everybody I know who has had them has a terrible tale of woe to share. Reading online didn’t help. Doubly worse, by the time I realized the itchy sore under my left breast wasn’t late season poison ivy and was in fact spread around my back like I’d been wrap-slapped with a Portuguese man-o-war it had been 5 or 6 days. Far too late to try an early stage anti-viral like acyclovir.

Crap!

So, me being me, I thought “well, Ivermectin seems to work against most classes of viruses, and works for late stage Covid, so why not?”

So I took another 600 mg (of paste) dose, slammed more zinc, and one other thing which may or may not have helped (some Arbidol I secured back in February). Within 48 hours I was on the mend. The nasty shingles rash stopped dead in its tracks, never progressed to the pustule stage, and went on the retreat.

Sure I still had the sensation that my left side had been kicked by a cow a week ago (that was my worst sensation – a deep bruise feel) but otherwise I got off very lucky.

Either I was due to have a very mild case (which happens sometimes) or I successfully treated it. I’m telling you in case you every get shingles…here’s a thing to try.

Either it was pure correlation or the Ivermectin + therapy I administered was curative. I’m 95% sure it was the ivermectin. I now hold that substance in very high regard. I wonder how many other ‘off label’ treatments are lurking out there with just as much powerful magic to offer.

Conclusion

I’m unwilling to be an early taker of the mRNA vaccine for three reasons:

insufficient safety data
insufficient long-term data, and
Ivermectin.

I’m unwilling to be a beta tester for this new vaccine modality. Let’s just wait and see. Unless this is the most amazing thing ever, there will be ‘learnings’ along the way.

Further, I full believe in the power of having ‘my terrain’ be tuned up as much as possible.

For this I am very thankful for Covid. I was basically a virus noob before Covid. Now I know things like that Vitamin D isn’t really a vitamin but a powerful immunomodulatory agent. Having enough of that in my body wasn’t really a priority before because I just didn’t know. I was ignorant. Now I’m not. It’s essential to fend off all sorts of things way beyond Covid and I’m thankful to know that.

I know about melatonin and how that works. Same story as for Vitamin D. Who knew all the things it did? I certainly didn’t.

I also did not know just how corrupt the US medical-corporate-political axis was. I suspected, but now I know. It’s awful. You have to advocate for yourself and not trust a single thing completely. Heck, I knew more than the first oncologist did about Hodgkin’s within about 3 days. That wasn’t their specialty, I made it mine. Covid gave me that too – the understanding that anybody with the time to read and be curious can know more than many so-called experts pretty quickly if those experts aren’t as curious or dedicated. Which happens a lot, by the way. It’s just people being people.