Gone Rambling

Go a little off topic

Coronavirus Update 07 Jan 2021

Coronavirus Archive

–Greetings fellow citizens! I am happy to provide you with a report of the progress since receiving my experimental vaccination 8 days ago. As you have learned from many of the leading internet experts on the mechanism of action of the vaccine, and its predictable effects, integration with my DNA is now complete. Mutagenesis for the purpose of biological enhancement has begun, and already the effects are noticeable–with minimal discomfort, praise be to Glorious Leader Gates! Within 48 hours, my entire skeleton had completed its biochemical conversion, replacing itself with an adamantium alloy many times stronger than my previous hoo-man bones. This was accompanied by a significant acceleration in my soft tissue healing rate–even the most minor wounds now heal themselves completely in seconds. Tissue oxygenation gains, with accompanying cardiac muscle hypertrophy and exercise endurance, appear to be closely correlated with this new hypermetabolic state. Gains in speed, power and strength have been exponential. These were preceded by significant changes in body composition with sudden and massive reduction in body fat percentage (independent of diet) and simultaneous hypertrophy of skeletal muscle (shockingly, independent of gravity dependent weight training).

“Gainz” as the gym bros say.

Photo of your author at work in the laboratory, vaccination D+3. Note body composition changes are incomplete at D+3, and would not classify as truly “swole” until D+5. However, retractable adamantium claw adaptations are clearly visible and already fully matured, even at this early timepoint. This precise pattern of adaptations status post vaccination appears specific to those with significant connection to Ann Arbor, Michigan, for reasons that are not fully clear. Geographic patterns of adaptation to vaccine DNA integration have been identified elsewhere. For example, many of those with equally strong connection to Columbus, Ohio have completed transition to hairless poisonous nuts, with no evidence of sentience. Fortunately, even these may find use as sustenance for pachyderms–testing is expected shortly.

Indeed, I reflect on previous state of unaugmented hoo-man DNA with a mixture of pity and contempt at its mortality, weaknesses, and evolutionary flaws, and elation that rationally designed enhancements have elevated me to a stronger, better existence. I can hardly consider what I was “natural” any longer–praise be Glorious Leader Gates.

Citizens, let us close this recitation of the success of vaccination enhancement program with our customary Pledge of Illuminati Compliance and Hymn of Post-Human Enlightenment, followed by recitation of our names, social security numbers, and current addresses.

–Yes, yes, I kid, I kid. Shoulder soreness was gone on day 2. No other adverse effects. Of all the folks I know who have got the vaccine, a little of the usual injection site soreness, and a few with some kinda/sorta/maybe fatigue (but tough to tell because it was right around New Years, and they went from sleeping in to up early again). That’s it. So far so good.

–As for temptation for antibody testing… good news, bad news.

Good news is I gave in and gave blood for antibody testing earlier this week.

Bad news is that I could not get an appointment with a lab running the right assay in the right time frame. Some of the major ones out there test the nucleocapsid gene antibodies, and NOT the spike protein antibodies. That’s a problem, because the vaccine is to the spike protein, so a test for antibodies to nucleocapsid are likely non-informative.

But the good news is that we are planning on bringing up a more comprehensive antibody panel at work, looking at multiple targets and multiple classes of antibodies.

But the bad news is that we don’t have it going just yet. So my blood is in storage until it’s ready. When I get some data, I’ll let you know.

–Separately, a reader reached out after the New Year’s update and mentioned their workplace (healthcare facility) is collecting baseline and post-vaccination samples on them for the same idea. The first shot should be a booster for anyone who was previously infected (even asymptomatically) and developed immunity, and so should be visible as a spike protein antibody level that is too much, too soon, and IgG from the drop. The vaccine in a person who has NEVER got an infectious exposure to SARS-CoV-2 or developed immunity to it yet should take 7-10 days and move from IgM class antibodies to IgG. So again, the difference in pattern should be telling.

The reader’s organization is not the only running this kind of experiment either. They should give us inference to a better sense of the true asymptomatic infection rate that has been out there.

–Speaking of the vaccine though, this is a short Twitter thread worth a quick read. However, I want to emphasize the caveats here. This is early data suggesting a higher rate of adverse events to COVID vaccines versus the flu vaccine, and may be “unlucky” so far. Further, the author’s point that because of spotlight on the COVID vaccine, anything that occurs after vaccination getting reported as a possible vaccine effect as doctors and nurses are primed to hypervigilant on this new vaccine may explain some of the difference as well. The rates may catch up as more people get the vaccine.

Also, even though rates of reported events are higher, you are still talking ~324 events out of ~1,000,000 COVID vaccine doses–or a 0.03% rate so far. Versus 0.0007% for the flu vaccine.

–The FDA also reported that the Moderna vaccine saw a handful of Phase 3 patients with recent dental fillers experience some extra swelling.

–Turning back to infection rates, you did it. You bastards went and did it. You decided to send 2020 off just a little bit on New Year’s. And now it’s pink from coast to coast on the John’s Hopkins new COVID cases tracker–right on time for everyone exposed on or around New Year’s to show up with symptoms.

So the spike we suggested was likely last week is here. Now we will watch in the coming week for knock on cases our revelers may have or now be infecting to see how sustained and how big the New Year’s spike will be.

–Around the horn, Japan and China both have more new cases. China closed off another city today as 200+ new cases were officially announced there. The UK is going back into lockdown. Etc etc. Your local situation may of course vary.

–Got a reader question about an article published online earlier this week. I’m not going to link it (mostly because I have managed to accidentally close the link off my phone). The gist is that the author is shocked, shocked I tell you that trials for the COVID vaccines are incomplete and that if you go and check them on Clinicaltrials.gov, you will find that they are listed as “ongoing.” As you can probably guess, this then dovetails into allegations of approval of these vaccines before any of the Phase 1, 2 or 3 trials were even complete and… well, this should be a familiar tale of worry and woe by now.

The new twist for this article is the “incomplete studies” and how the Pfizer publication, for instance, was on “interim data.”

I will lay money that the author of this online article has never written or performed a clinical trial before. What they don’t know that they don’t know is that interim data locks like this are built into every clinical trial. And they are pre-defined BEFORE the study even starts. Usually interims happen at some convenient milestone, either a certain number of “events” (clear clinical outcomes the study seeks to measure) or after a certain number of patients have been enrolled and received the study intervention long enough for some sign of effectiveness. A key component of them is safety. If the study arm has worrying adverse events, or worrying rates of events, it may halt the study and keep other patients from enrolling onto what could be a dangerous intervention. Often, they will be checked for futility as well. It’s important to mention that these will still be blinded, and/or a neutral “referee” of physicians and scientists will review the data. The number of events or patients to trigger interim analysis are calculated to have enough statistical heft to estimate how likely the intervention will be to show efficacy if all the expected patients ultimately enroll. So if the drug is not looking likely to beat placebo, or doing worse than placebo, you can cancel the trial early. That way, patients can enroll in a different study, where hopefully the intervention is more successful and not waste their precious time and health.

On the other hand, interim analysis can also suggest that the intervention is almost certain to beat the placebo–to the point that you start question if it’s ethical to not offer the treatment to everybody. This is the interim result you hope for. And yeah, if you hit, you’ll be racing to register that drug.

So, going back to the COVID vaccines. The trials yes are still on going–mostly because they want to measure duration of immune response and any possible late side effects. They will follow for probably 6 months to a year. I am presuming that the author of this website wants that data right? Okay. You keep the trial open until all the patients (all of them, and remember, not everyone signed up at the same time) have that data. At that point, the trial will be closed for final data lock and analysis. The final results will be published. It’s not uncommon, and in fact quite common, to publish and present clinical data of on going clinical trials based on the interim data locks before that though.

The vaccine studies started what, late summer? They don’t have 6 month to 1 year duration of immune response data yet. What they DO have is published Phase 1 safety data (both Moderna and Pfizer). There is not going to be too much more to add to that unless something attributable to vaccination happens to some patients 6-12 months down the road. They also have interim efficacy and safety on the Phase 3s (Pfizer has published theirs; regulatory agencies have reviewed both). That interim was on 43,000+ patients for Pfizer alone. That’s a big trial and a huge interim. For comparison, here’s a flu vaccine publishing two Phase 3 studies in a little under 23,000 patients. Total. For both studies combined.

That interim analysis confirmed much of the phase 1 safety data (at least for early potential adverse events) AND showed significant efficacy. Enough efficacy that it was worth accelerating into the clinic to fight a pandemic through Emergency Use Authorization procedures. That’s because the pandemic was emergent enough to cause 2020 to be well, 2020, right? The regulatory bodies will expect the full data set once the 6 month to 1 year follow up is complete.

On all 43,000 patients (in just the Pfizer study).

The earliest enrollees of which might just be getting to 6 months follow up late this month, sometime next? Maybe?

The trial won’t officially close until then–but we can measure antibodies, T-cells, and count who got COVID after their vaccine or placebo shot thus far. We can also look at side effects for a vaccine whose mRNA is around for 48-96 hours tops.

At any rate, that’s why the studies are still open, but the vaccines are being issued.

Hopefully, that makes sense.

–In other popular comments and headlines…

“Death/hospitalization counts look like 2018 in [state, country]!  This means it’s just a bad flu! Plandemic!

That is one interpretation of that data, sure…. sure….

But the other is that those rates looking similar means lockdowns and other public health interventions worked : )

I’ll explain.

Remember when comparing to previous years’ data — you did not intervene in the same way as you did in 2020!  So it’s not an apples to apples comparison as a result.  

2020 looking similar to 2018 could be because the virus was overestimated and was just a really bad flu–if and only if the interventions did nothing and the virus was truly just “bad flu.” Thus, the effect you see in the data is solely due to the virus, and turns out the virus was not as bad as advertised.

Alternatively, and equally plausible given the data, is that the interventions worked and the ONLY reason 2020 rates look similar to 2018 (or only slightly worse) is that we intervened.  This explanation is true if and only if, the virus really was more dangerous than the flu, and the interventions were successful. Thus, you would see a much higher difference in 2020 vs. 2018 (because the virus is nasty, but lives were saved and hospitalizations avoided by flattening the curve).

In fact, you can argue the “interventions worked” case most strongly by invoking flu, for whom social distancing has been catastrophic.  If you hate lockdowns, lemme tell you how influenza feels about them right now…  On the other hand, God, in His divine mercy, may have seen how quickly the situation was spiraling out of control here based on just coronavirus and graced us with a very mild flu season.  Or we just got lucky with a very mild flu season (if you prefer to leave God out of it).  We don’t know for sure which it is—very mild flu by chance alone or very successful public health interventions hammering flu, which spreads like the similar coronavirus.

The truth is more probably between these extremes.  Someone arguing one of these extremes as conclusive, or conclusively proven, might be best regarded as mistaking their most preferred explanation for the most probable.

The main point is that the idea is to form a hypothesis and then -do- the experiment that would prove the hypothesis wrong.  You have to try your level best to kill your darling.

As we have discussed before, when it comes to lockdowns and other public health interventions of 2020, there is no control group, and there is no uniform set of measuring adherence to the interventions, and very different interventions were attempted in different times in different places all over. Those interventions evolved with “science”.  Thus, the main limitation of the retrospective cohort studies (which is essentially what you are doing comparing 2020 stats to other years) is that you do not have control of all the variables.  So any effect you see may be from different causes, and the same data can generate different hypotheses to explain it. Thus, retrospective cohort studies like these are most useful for hypothesis generation–but hopefully we do not get the opportunity to test our hypotheses from them prospectively on another pandemic! 

–Off topic a bit, but about yesterday at the US Capitol building. Can it be that you have not watched “The Social Dilemma” yet? But the last element of the “story” in the documentary speaks directly to what happened yesterday. And before yesterday. And what is likely to come. And why the fix is not what you might think it is.

Can it truly be you haven’t seen it yet?

–Last off topic, Jack Ma has fallen off the face of the earth. China’s richest man, disappeared for two months. I mention this only because this video was shot about a year or two ago–both of the predictions made starting at 43:20 in this video have apparently come to pass now: https://m.youtube.com/watch?v=4cwXifDaCjE&t=2600s

–Your chances of coronavirus are equivalent to the chances that I wish “The Witcher” was higher in pop culture consciousness as the picture and description for the “mutations” caused by the virus–if only because it connects to the sterility conspiranoia for the COVID vaccines too well.

Plus the meme from the Netflix series would have been easily apropos.

<Paladin>