Day 688: Lockdowns Never Work Again

The Wall Street Journal reports that lockdowns never worked and were never going to work. They trace the unscientific temptation to lock down to Neil Ferguson's famously bad models, but lay the ultimate blame at the feet of politicians:

So why did public-health authorities abandon their opposition to lockdowns? Why did they rush to embrace the untested claims of flawed epidemiological modeling? One answer appears in the Johns Hopkins study from 2019: “Some NPIs, such as travel restrictions and quarantine, might be pursued for social or political purposes by political leaders, rather than pursued because of public health evidence.”

That's a bit circular, to echo their critique of self-validating models. Eugyppius gave a more concrete explanation a month ago: politicians are just as ignorant and afraid as the average man of these crazy times, yet they get to make the decisions:

In an interview I will never find again, someone asked Noam Chomsky about the failures surrounding the American debacle in Afghanistan. He responded that it was above all a reflection of the distorted and inaccurate intelligence assessments that pollute the thought of American foreign policy planners and military strategists. Random people on the internet, he said, had a better view of the situation from the start.

Exactly the same phenomenon plagues official responses to Corona. The problem with curated information isn’t just that it is slow, subject to inertia, and produced by insular out-of-touch functionaries. Because the information has political importance, there are incentives everywhere to manipulate and degrade its quality. Bureaucratic actors will lie about what is going on to curry favour, save face or evade blame. What is more, many advisers, analysts and modellers are only in the position of providing analysis in the first place, because we need more women in STEM, or because they tell the Faucis of the world what they want to hear, or because they have the right combination of sociopathy and narrow-mindedness necessary to ascend complex bureaucratic hierarchies.

Corona policies really are as stupid as they look. Politicians and bureaucrats have locked themselves into a sad parody of the film Contagion, and their increasingly unsustainable, erratic behaviour merely reflects their desperation.

Day 687: The Little Variant That Couldn’t

The data on Omicron continues to be very reassuring, with negligible morbidity and mortality despite its communicability. For example, Alex Berenson reports on auspicious numbers from South Africa and Denmark.

Day 686: Nine Deaths per Atlanta

Here at PlagueBlog headquarters, we thought we'd be blogging more of your usual COVID chaos today, but instead we have the CDC unexpectedly backing down on Johnson & Johnson and a surprise Pfizer trial failure.

PlagueBlog doesn't take the claim of nine deaths from J&J seriously; estimates based on VAERS data put the COVID vaccine death toll somewhere above 9 deaths per half hour, with about one of those due to J&J and the other eight due to the mRNA-based vaccines. Steve Kirsch puts the estimate even higher, at 388,000 total deaths in the US, based in part on his old estimate of at least 150,000 and also on new data from "Wayne at VAERS Analysis" (whose own estimate is 407,831).

Sadly, Pfizer's trial issues may not lead to a welcome delay in unnecessarily jabbing the children:

[Pfizer] said on Friday that its study in children between the ages of 2 and 4 who were given two 3-microgram doses of the vaccine found it did not create the same immune response that a larger dose of the vaccine had in older children.

The 3-microgram dose did generate a similar immune response in children aged 6 to 24 months, the company said.

The company said it will now test a three-dose course in both age groups, as well as in older children. It had previously expected data from 2- to 4-year-olds this year, but said it did not expect the delay would meaningfully change plans to file for emergency use authorization in the second quarter of 2022.

P.S. Massachusetts cases were up seven tenths of a percentage point today.

Day 685: National Nullification Day

It's the anniversary of the Boston Tea Party, and in imitation of the spirit (if not the catchy sloganeering) of our ancestors, the Unity Project has declared it National Nullification Day. Though the call is for general COVID rebellion, the organization itself is particularly devoted to not jabbing schoolchildren.

Why rebel? Just for example, The Washington Post opines on the FDA and CDC progressing from ignoring their expert panels to failing to convene expert panels at all—most notably in extending boosters to 16- and 17-year-olds with no discussion of myocarditis, or anything else.

In local news, Omicron is speeding around Massachusetts faster than we can sequence it—which apparently isn't all that fast:

Researchers from Yale New Haven Hospital and the University of Washington this week posted data showing increasing numbers of samples with the genetic change.

But it takes seven to 10 days to complete the full genomic sequencing that would confirm the presence of Omicron. As a result, the official case counts probably represent a fraction of the current infections, Lemieux said.

“It is alarming to see how quickly this virus is spreading,” said Bronwyn MacInnis, director of pathogen genomic surveillance at the Broad Institute.

P.S. Massachusetts cases were up two-thirds of a percentage point today.

Day 684: Hurting the Children

Vinay Prasad posts an impassioned condemnation of all the damage done to children in the name of Science. He mentions the underpowered trial used to emergency-authorize Pfizer's vaccine for children 5–11 despite the dangers, but devotes more words to school closures and small cloth masks:

Some have claimed that our policies to children reflect “following the science.” They do not. There is no science to support primary school closure. No science supported prolonged (>1 year) closure for any age. No science supported outdoor cloth mask mandates for young kids, and no science supported deviating from the WHO guidance [on masks]. These policies meanwhile have devastating consequences for the well-being of children.

The one thing he gets wrong is that no organization stood up for the children; Children's Health Defense did.

P.S. Alex Berenson mocks Moderna for "pulling out of a major biotech industry conference in January because it’s afraid of Covid":

[A] company that has sold upwards of $15 billion in mRNA Covid vaccines this year won’t participate in a conference in San Francisco next month.

Apparently too many people will be going, or some such.

Now that’s confidence in your product!

P.S. Massachusetts cases were up three-fifths of a percentage point today.

Day 683: Spikevax Forever

On the whatever doesn't kill you makes you stronger front, a preprint out of Kaiser Permanente shows Moderna vaccination is still effective after 8 months:

Results: 927,004 recipients of 2 doses of mRNA-1273 were matched to 927,004 unvaccinated individuals. VE [vaccine effectiveness] (95% CI) was 82.8% (82.2-83.3%) against SARS-CoV-2 infection, 96.1% (95.5-96.6%) against COVID-19 hospitalization, and 97.2% (94.8-98.4%) against COVID-19 hospital death. VE against SARS-CoV-2 infection was similar by age, sex, and race/ethnicity, and was 86.5% (84.8-88.0%) during the Delta period. VE against SARS-CoV-2 infection decreased from 88.0% at 0-<2 months to 75.5% at 6-<8 months. Conclusions: These interim results provide continued evidence for protection of 2 doses of mRNA-1273 against SARS-CoV-2 infection over 8 months post-vaccination and during the Delta period, and against COVID-19 hospitalization and hospital death.

Although it would have been simple enough to also calculate all-cause mortality, sadly the authors did not approach that hot potato.

P.S. Massachusetts cases were up less than half a percentage point today, but that's similar to last Tuesday. The weekend total was also similar to the previous weekend, so no signs of improvement yet.

Day 682: Myopericarditis in Ontario

There's an important preprint out of Ontario about local rates of "myocarditis/pericarditis" after vaccination, stratified by mRNA vaccine. H/T Vinay Prasad, who made a video about the results and their implications for vaccine policy. The conclusion:

Results: There were 19,740,741 doses of mRNA vaccines administered and 297 reports of myocarditis/pericarditis meeting our inclusion criteria. Among these, 69.7% occurred following the second dose of COVID-19 mRNA vaccine and 76.8% occurred in males. The median age of individuals with a reported event was 24 years. The highest reporting rate of myocarditis/pericarditis was observed in males aged 18-24 years following mRNA-1273 [Moderna] as the second dose; the rate in this age group was 5.1 (95% CI 1.9-15.5) times higher than the rate following BNT162b2 [Pfizer] as the second dose. Overall reporting rates were higher when the inter-dose interval was shorter (i.e., ≤30 days) for both vaccine products. Among individuals who received mRNA-1273 [Moderna] for the second dose, rates were higher for those who had a heterologous as opposed to homologous vaccine schedule.

Conclusions and Relevance: Our results suggest that vaccine product, inter-dose interval and vaccine schedule combinations may play a role in the risk of myocarditis/pericarditis, in addition to age and sex. Certain programmatic strategies could reduce the risk of myocarditis/pericarditis following mRNA vaccines.

Dr. Prasad goes into some detail about the various rates of myocarditis, some of which were quite high, and the "programmatic strategies" (avoiding Moderna and spacing shots more widely) for reducing this side-effect in young males. Nevertheless, PlagueBlog continues to recommend not injecting people who are at negligible risk of dying of COVID with vaccines that pose unprecedented risks of cardiac side effects.

Day 681: Hackeado

Hackers have erased Brazil's vaccine database, derailing the government's vaccine passport plans for the time being, if not permanently.

Day 678: Mouthwash

A Republican senator dared to mention the fact that mouthwash kills COVID, leading to the usual flurry of "fact check" hemming and hawing over facts the fact checkers don't know or don't like.

On the post-moderna front, Canada has quietly backed off of Moderna for teenaged boys, following in the footsteps of several European countries.

P.S. Massachusetts cases were up almost two thirds of a percentage point today.

Day 677: Immortal Time

Immortal time has nothing to do with the FDA doubling down and asking a federal judge for 75 years to release Pfizer's COVID vaccine approval application under an FOIA request. Seriously.

Here at PlagueBlog headquarters, we find it hard to resist the temptation to pronounce it "immortal time" like some sci-fi concept, but it's really "immortal time": the time during which a subject in the treatment group cannot die from the disease being treated.

Immortal time is generally due to a delay in the treatment process that causes patients to count as untreated for some interval, during which they can die of the disease or other causes. This makes the treatment look more effective against the disease (or against the proxy of all-cause mortality) than it actually is. Depending on the length of immortal time and the fragility of the patient population, this can be a significant statistical issue.

While the initial Pfizer trial was too brief and front-loaded with healthy people to need immortal time correction, population statistics for COVID vaccine rollouts do need adjustments for the long window (at least 14 days) of vaccinated but unprotected time. Patients in this window frequently find themselves in the unvaccinated column—though who is in which column is its own vexing issue with COVID data. Since the old and infirm get priority for vaccination, they can artificially inflate efficacy of the vaccine, or even create efficacy where none actually exists.

Troubling though immortal time is, it is only one of many statistical gotchas in calculating vaccine efficacy. Several of these issues are explained in a recent blog post and paper by Norman Fenton and Martin Neil, with regards to ONS England data.

Correlating unvaccinated mortality with vaccine roll out we see curious patterns (dotted line the proportion of people getting first and second doses). Why are the unvaccinated dying after NOT getting the 1st dose? Why are the single dosed dying after NOT getting the 2nd dose?

Plenty of evidence that the vaccinated who die within 14 days of vaccination may be categorized as unvaccinated. Then someone who dies within 14 days of first dose is miscategorised as unvaccinated and a similar thing could occur post second dose.

This theory could be described as "safe but ineffective", as opposed to the more common "unsafe but effective" theories that attribute excess deaths (regardless of how they are categorized) to vaccine side-effects. However, the authors do find some excess deaths to account for, and postulate that vaccines are, in fact, increasing mortality—but through innate risks of vaccination rather than adverse effects per se:

However, in interpreting these results it is important to avoid an overly simplistic understanding of the processes at play before and after vaccination. On the one hand, after vaccination the vaccinee is reported to endure a weakened immune response, [19], [21], for a period of up to 28 days [20] and may be in danger of infection from Covid or some other infectious agent at any time during that period. On the other hand, infection prior to vaccination, where Covid remaining symptomless for a period of up to three days, might endanger the vaccinee after vaccination because vaccination is supposed to be prohibited for 3-4 weeks after contracting Covid.

P.S. Massachusetts cases are up three fifths of a percentage point again today. We're approaching 6000 daily cases and looking a lot like this time last December.

Day 676: Where in the World is Gavin Newsom Again?

Steve Kirsch remains hot on the trail of the elusive Gavin Newsom, who's apparently still been scarce since the wedding sighting. While the story has fallen off the news/debunking cycle, Steve Kirsch maintains that (after stem cell therapy in Mexico disguised as yet more family time) the governor is still AWOL:

He’s occasionally surfaced since his disappearance, but has never (AFAIK) been seen in public where he’s walking around, shaking hands, etc.

In other underappreciated weeks-old stories, eugyppius reiterates that testing in Israel proves the vaccines are doing nothing to stop transmission:

The more you control for different rates of testing, the harder it gets to find vaccine effectiveness against transmission, and the more you start stumbling over evidence of negative efficacy. This is why we find evidence of negative efficacy in the UK data but not (for example) in the German data. In the UK, unlike in Germany, the unvaccinated are not subject to constant testing rules. In Israel, all national airport arrivals are tested regardless of vaccination status. These numbers, widely discussed a few weeks ago, show far lower third-dose efficacy than claimed, and also indicate negative efficacy among the double vaccinated for the month of August. Because unvaccinated arrivals to Israel are quarantined and subject to additional testing, however, even these numbers are imperfect.

When you test everyone all the time regardless of vaccination status, a very different picture emerges.

P.S. Massachusetts cases were up almost half a percentage point today.

Day 675: Poo Pending

Elevated COVID results from MRWA wastewater testing means that the virus is on the rise in the greater Boston area:

“The wastewater is predictive, and when it’s going up like this, you expect a significant surge in cases,” said Todd Ellerin, director of infectious diseases at South Shore Health. “Then in the weeks to follow, you see an increase in hospitalizations and an increase in deaths.”

Infections and hospitalizations have been spiking in Massachusetts for weeks. The state Department of Public Health reported more than 5,000 daily cases on Thursday and Friday, which were the first days exceeding 5,000 infections since January.

Massachusetts cases were up about two fifths of a percentage point a day over the weekend and today.

Day 673: It's Coming From Inside the House

Omicron has entered Massachusetts.

Day 672: Rumors of Our Demise…

Don't fall for the rumors of overflowing ICUs in Massachusetts. It's one university hospital with staffing issues in Worcester, hardly the medical center of the state. (I guess that's what happens when you fire a bunch of employees for not getting vaccinated.)

P.S. Massachusetts cases were up three fifths of a percentage point again today.

Day 671: Pfizer Leaking

Mathew Crawford evaluates some Pfizer vaccine safety documentation released on the FDA's 55-year plan to respond to a FOIA lawsuit. He mistook it for a leak, but later provided a link to the released document.

Mortality Envelope Math

There appear to be 20,000 or so cases of SAEs in the report, and in the initial Pfizer trial, 0.7% of those injected suffered one or more SAEs. I suspect this percentage is low given the extremely healthy nature of the participants in the initial Pfizer trial (based on all-case mortality rates and cardiac events in both arms), but it will do for some basic envelope math.

20,000 is 0.7% of 2,850,000 [injected individuals], give or take, so I take that as the population reach of this particular report. The 1223 fatalities represents 430 deaths per million individuals injected, which falls very near numbers that I have computed several times over[.]

Also of interest today is the sequence for Omicron and its distance from the rest of the Greek alphabet of variants. Science Magazine reports:

Omicron clearly did not develop out of one of the earlier variants of concern, such as Alpha or Delta. Instead, it appears to have evolved in parallel—and in the dark. Omicron is so different from the millions of SARS-CoV-2 genomes that have been shared publicly that pinpointing its closest relative is difficult, says Emma Hodcroft, a virologist at the University of Bern. It likely diverged early from other strains, she says. “I would say it goes back to mid-2020.”

That raises the question of where Omicron’s predecessors lurked for more than a year. Scientists see essentially three possible explanations: The virus could have circulated and evolved in a population with little surveillance and sequencing. It could have gestated in a chronically infected COVID-19 patient. Or it might have evolved in a nonhuman species, from which it recently spilled back into people.

P.S. Massachusetts cases were up three fifths of a percentage point today.

Day 670: For Your Spikopathy

Breaking news: Omicron has entered the country.

Via Dr. Meryl Nass: the World Council for Health has some advice for treating exposure to the spike protein, regardless of source. A bit of their advice is generic (multivitamins, intermittent fasting) or downright silly (avoid GMOs). Frankinense is seasonal, at least, and nigella is tasty. (They provide dosages and other helpful information, such as that potatoes come from grocery stores.)

At the other end of their spectrum of recommended drugs, teas, and supplements, there has been some promising research into N-acetylcysteine (NAC) vs. COVID, which is still available as a supplement in the US if you look hard enough. It even made their top ten:

• Vitamin D
• Vitamin C
• NAC (N-acetylcysteine)
• Ivermectin
• Nigella seed (a.k.a. black cumin, unfortunately not the only thing called black cumin)
• Quercetin (a flavonol flavonoid)
• Zinc
• Magnesium
• Curcumin (essentially turmeric)
• Milk thistle extract

P.S. Massachusetts cases were up three fifths of a percentage point today.

Day 669: Counting the Days

PlagueBlog's day count is of the days since COVID-19 officially arrived in Massachusetts (straight from Wuhan), but others are also counting the days. At r/flattenthecurvecount, "it's day 632 of 15 days to flatten the curve." At artist/vlogger Sir Wizzo's Instagram it's "day 623 of the coronavirus catastrophe." But closest in pace to us is a more all-caps political COVID chronicle called Nextrush Free, where it's "Day [625] of the Dictatorship of COVID-19, Day [625] of America and the World held hostage to COVID shots." Don't be fooled by the miscount; the blog predates the jabs.

Of perhaps more interest than an all-caps history of the plague years is eugyppius' latest post linking the great awokening to coronavirus craziness on campus. He believes COVID may bring down the ivory tower in the end—but all without conspiracies or direction, because that's the nature of the bureaucratic West.

P.S. Massachusetts cases were up two fifths of a percentage point.

Day 668: Not So Fast

One of the actual surprises of the Omicron variant was when thirteen or fourteen passengers (depending on which news report you read) apparently became infected with it aboard two flights from South Africa to the Netherlands. It turns out 61 of about 600 passengers tested during that Omicron airport panic had COVID of various lettering.

A reporter trapped aboard one of the planes after it landed reported that passengers had to be tested to board, making Omicron look very speedy indeed, but the Wall Street Journal reports that many of the vaccinated weren't tested because they held an EU vaccine passport. Though they quibble about whether the COVID cases occurred among the untested vaccinated or were acquired in mid-flight, the Dutch press reports that testing indicates the cases probably did not originate aboard the plane.

In you may already be a downer news, Steve Kirsch, who's been grousing lately about getting banned from Twitter for saying COVID vaccines cause prion disease, has put together some numbers from VAERS in order to estimate when people who die of the vaccines actually die: 45% in the first two weeks, and so on. Part of the data is behind his paywall, but the curve looks pretty smooth up until that point.

P.S. Massachusetts' case numbers for the weekend plus Monday average out to only a fifth of a percentage point increase, but there may be lingering data delays due to Thanksgiving.

Day 666 Retrospective: Nu Omicron

Saturday was day 666 of COVID-19 in Massachusetts. We're getting close to two years since an infected grad student from Wuhan touched down at Logan and became our first official case. To celebrate, we're freaking out on cue about a variant out of Africa that has killed no one that we know of to date. You may have heard the variant referred to as Nu early on, as that was next in the Greek alphabet, but the WHO decided Nu sounded too much like "new" and Xi sounded too much like Xi, so skipped ahead to Omicron.

You'd think people would be begging to let Omicrons into the country to push out our deadly Deltas the way Alpha banished the flu (however temporarily). But no, New York State announced a state of emergency over a probably harmless variant that isn't even in the country, never mind in the state.

Day 664: Soccer Kills

Israeli journalist Yaffa Shir-Raz attempts to quantify sudden soccer death syndrome the massive increase in players falling over on the field from cardiac events—all without mentioning the vaccines. Stephen Connolly collects and discusses her tweets about it here. She counts 183 "professional athletes and coaches" collapsing on or near the field in the past year, out of whom 108 died. For the sake of statistics, she counts up the recent deaths in FIFA specifically (21) compared to an annual rate of 4.2 over the past two decades, and finds that statistically signifcant.

Day 663: MIS-V

A ponderously-titled case report in Vaccines, Autoantibody Release in Children after Corona Virus mRNA Vaccination: A Risk Factor of Multisystem Inflammatory Syndrome?, recounts the difficulties in identifying and treating multisystem inflammatory syndrome in a Pfizer-vaccinated, COVID-negative 18-year-old, partly because MIS can occur up to 12 weeks after infection (or in this case, injection).

Interestingly, they note that multisystem inflammatory syndrome in adults (MIS-A) is a known side-effect of COVID vaccines and abbreviate it MIS-V, multisystem inflammatory syndrome after vaccination, following an earlier case study. They postulate a mechanism, "elevated functional autoantibodies against G-protein-coupled receptors", and casually note the negligible mortality rates of COVID in pediatric patients, as opposed to the real risks of MIS-V.

They cite the only previous case study in children, a healthy 17-year-old from Denmark; the EU report on it mentions that MIS-C occurs naturally at a rate of 2–6 per 100,000, and MIS-A at less than 2 in 100,000. For the record, VAERS is now up to 54 cases of MIS-V ever, with two from other vaccines and two bad entries with no vax listed that are still clearly about COVID. (The new one is about a 15-year-old.) Nine cases are clearly in adults, while the rest are under 30 and may or may not be MIS-C, as the cutoff for pediatric cases is 20 but VAERS groups 18–29 together.

On another topic, one of the known side-effects of lying to and gaslighting people is named "confession by projection". You can see it in action by rereading this hit piece on Alex Berenson that The Atlantic ran in April, and observing who was really spouting the "half-truths, untruths, and obfuscations." (You'd think the CDC would admit to at least one vaccine death, if only to get people to stop quoting their unbelievable zero deaths.)

P.S. Masssachusetts cases were up four elevenths of a percentage point today.

Day 662: All of the Data So Far

I was skimming a New York Times article about the children's surge when I came across this laughable conclusion:

All of the data so far indicates that the vaccines are far safer than a bout of Covid, even for children.

I suppose with the FDA on the 50-year plan of releasing data about Pfizer's vaccine, some extremely ignorant journalist might feel he could get away with a howler like that. Sadly, the only thing that says the vaccines are safe for children at all is a lot of hot air from the CDC about "mild" myocarditis and zero, count them, zero deaths from the vaccines for all ages. Add to that obvious undercount their senseless exaggeration of the risks of COVID to healthy children, and you get a cure that's impossibly safer than the disease.

If you want a dose of reality, though, Dr. Meryl Nass elaborates on the actual data; children are at an uncertain but significant level of risk from the known and unknown dangers of an entirely new vaccine technology, and at statistically no risk from COVID.

Massachusetts cases were up a third of a percentage point today.

Day 661: Diseases of Heart

This past summer, a quant named Austin G. Walters blogged about the slow revision of weekly CDC deaths from an undetermined cause of death (often pending COVID test results) to "diseases of heart":

At this point, we will still have another three to four weeks to identify exactly what is going on here. January 2021 appears to have a seasonal increase due to COVID-19, correlating with a rise in all causes of death. The question, is whether or not the increase in diseases of heart continues to be high.

Currently, fatalities related to diseases of heart are running one to three thousand higher than in the summer and early fall of 2020. If the deaths associated with ICD10 R00-R99 [undetermined] continue to be changed to diseases of heart (seems likely, given the decreasing COVID19 cases) that would be somewhat alarming.

Unfortunately he stopped COVID-blogging soon after and never updated with the next month of data.

On a similar topic, an abstract of Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning claims that mRNA vaccines increased the likelihood of acute coronary events in the next 5 years from 11% to 25% among their patient group.

Day 660: Death by All Cause Mortality

There's a simple statistical test that a new medication used to have to pass: it should not increase the rate of death in the patient population. If it does somehow increase deaths by all causes we blame the medication, even when the precise mechanism is unknown.

Sadly, that does not always mean that we stop using the medication. Antipsychotic drugs increase mortality in all patients but the majority of effort seems to go into preventing their prescription for the elderly. Some drugs aren't intended to end in recovery, such as cancer drugs that just need to kill the patient more slowly than the disease, and get a lot of leeway from the FDA to prove it. But in general, the cure being worse than the disease used to mean the cure didn't go to market or stay on the market long.

Those were the days. Alex Berenson reports on a 20% increase in deaths after vaccination in Sweden and double the death rate for the vaccinated under 60 in England.

The English data is a bit of a mess, but Steve Kirsch reports on a solid pattern of excess deaths among the vaccinated in Germany. He's previously counted up excess American deaths six ways from Sunday to get 150,000.

If you want to jab according to your personal odds of excess death, a new preprint evaluates US and European data to determine that the vax is worse than the disease for all young people as well as "older adults with low occupational risk or previous coronavirus exposure". And Vinay Prasad blogs a bit about boosting (above the paywall); in short, we know nothing except that there's been a bit of post-Pfizer-booster myocarditis in Israel.

On an apparently different topic, PlagueBlog staff have been monitoring the vaccine-induced myocarditis paper that Elsevier took down "temporarily" over a month ago for no good reason. As of our last check it was still down, and author Peter McCullough is now suing his publisher:

Dr McCullough wants answers as to why Elsevier chose to withhold this important research from both the public and the scientific community. However, we know that the answer is that real and genuine science completely disproves the supposed “safety” and “effectiveness” of these vaccines.

“The most notable finding is that this myocarditis heart inflammation that occurs typically on the second shot after either Pfizer or Moderna, it is explosive and it happens within a few days of the second shot,” Dr. McCullough said.

In other apparently unrelated news, Sergio Agüero is retiring from soccer due to the sudden arrhythmia he suffered on the field last month. He is 33 years old and has been playing professionally since he was 15.

P.S. Mathew Crawford untangles the UK death data to show the vaccines are merely ineffective, not doubling the death rate. However, he believes in 100,000 excess deaths caused by mRNA vaccines in the US and frequently mistaken for COVID deaths. This is especially interesting because vaccination is "known" to temporarily increase susceptibility to COVID.

Day 659: Return of the Lab Leak

Alert readers may have noticed the recent rehabilitation of the lab leak hypothesis. Tablet Magazine doesn't quite explain its renaissance, but does give a detailed account of its original fall from grace:

The backlash to Cotton’s comment, swift and vociferous, would mark a turning point in the media’s approach to covering and investigating the origins of the virus. On Feb. 17, The New York Times and The Washington Post ran twin reports accusing Cotton of repeating a noncredible “fringe theory” about the origins of the virus, and taking particular issue with his comments on Fox News the previous day that “we don’t have evidence that this disease originated [in the Wuhan lab], but because of China’s duplicity and dishonesty from the beginning, we need to at least ask the question to see what the evidence says. And China right now is not giving any evidence on that question at all.” Both stories claimed that there was a consensus among experts that the so-called lab leak theory had been comprehensively dismissed.

Cotton’s line at the time was difficult to distinguish from mainstream coverage of The Lancet paper, and from presidential candidate Joe Biden’s later insistence to CNN that “I would not be taking China’s word for it. I would insist that China allow our scientists in to make a hard determination of how it started, where it’s from, how far along it is. Because that is not happening now.” So what was wrong with what Cotton said?

While the top-line reporting was the same from the Post and the Times, each paper took a different approach to the nuances of the story. The Post conflated Cotton’s remarks about a possible accidental leak from a scientific lab with an assertion that the virus might have been connected to a Chinese bioweapons program—something Cotton never claimed, and which no statement from anyone on or off the record had even suggested. (The Post issued a correction to the article over a year later, removing the terms “debunked” and “conspiracy theory” and noting that “then as now, there was no determination about the origins of the virus.”)

And so on...

Day 658: Respiked and Rereiched

Moderna gloats that the FDA has approved their half-strength booster for all adults:

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

The booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. On October 20th, the FDA authorized for emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 µg mRNA 1273 third dose in immunocompromised individuals.

The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.

The FDA followed up with a Pfizer approval soon after. They await the usual CDC rubber stamp. [P.S.: Halfway stamped already... Smell that rubber burn!]

Meanwhile, Austria is rapidly leaping from Reich to Reich, with the recent lockdown of the unvaccinated expanding now to a full lockdown and universal vaccination mandate. Martin Lichtmesz describes the eerily familiar demonization of the unvaxxed at eugyppius' blog, without mentioning a single yellow star:

When will the police be at the door? When will vaccine refusal have criminal consequences? When will it result in fines of the sort that will destroy people of modest means? In the climate that is descending around us, anything seems possible. Social, legal, and medical-ethical standards are rapidly disintegrating, state overreach is becoming the norm. Already, among the unvaccinated, the feeling is spreading that they are outlaws and have their backs against the wall.

Of course, these “tightened measures” at the expense of the unvaccinated have not had the slightest effect on “the numbers,” which, according to the press, are once again “exploding.” They have finally, and totally predictably, resulted in this “lockdown for all.” Perhaps they intended this from the beginning, and were merely waiting for a dramatic spike to cause emotions to boil over.

This renewed “lockdown for all” will make a lot of people who have dutifully gone along with everything to this point extremely angry, and so the political and the media establishment have already provided a target for this anger and frustration: The blame for everything – for the lockdown, the high incidences, the high ICU occupancy, the alleged triage, the corpses piling up in the corridors [link to an article in German about false media propaganda], and so forth – lies with the well-poisoners, the “vaccine refuseniks”, the “hesitants,” the “Querdenker” [the “lateral thinkers” – a populist grassroots Corona sceptic movement in Germany and Austria], etc. No few people are now openly wishing death upon these noncompliants.

Had they been vaccinated – so goes their conspiratorial narrative – we’d all be free of Corona and the national government would not be forced by lack of alternative to impose these draconian measures. They’ve brought all of this on themselves. Whining just amounts to an insubordinate miming of the victim's role. They must be punished, educated, and forced, if argument and persuasion cannot help. The mob are so certain of themselves, they have even produced smiling priests who publicly boast that they have “no sympathy for the unvaccinated.”

Read the whole thing. It makes Massachusetts' groupthink look positively open-minded.

P.S. Massachusetts cases were up a third of a percentage point today.

Day 657: More Mask Myths

I have been pondering for a long time, how our entire response to Corona every day grows more bizarre and detached from any conceivable, realisable goal or rational purpose. I understand why many detect behind this broken response the machinations of evil conspirators, and indeed it often seems that all of this is being managed for maximum chaos and destruction. I’ve tried to offer different explanations: Perverse bureaucratic incentives, managerial blindness and iterative institutional processes surely all play a role here, but a failure this profound will have many facets. — eugyppius

On to the topic of the day: more mask efficacy numbers pulled out of thin air. On this pandemic episode of Sesame Street, the number of the day is 53%. Vinay Prasad fisks this number down to 11% or less:

Interestingly, in the only published cluster RCT [randomized controlled trial] to date during COVID19, surgical masks had an 11% risk reduction and cloth masks had no effect at all on the primary endpoint of symptom driven lab positive results. That cluster RCT took place in a location with essentially no vaccination (aka circumstances which would give masks the best chance to show the best effect size).

The only other completed RCT during the pandemic, DANMASK was null as to the effect of surgical masks, and had been powered to detect a 50% reduction. At the time, many complained DANMASK was underpowered. Masks worked, but not that well, they argued. Yet, it appears now DANMASK was adequately powered if one is to believe the 53% estimate. So which is it? Was DANMASK adequately powered or not? Is 50% plausible or not?

Before you answer, let’s remember that even the authors of the 53% study write, “Risk of bias across the six studies ranged from moderate to serious or critical.” I never thought I would be wishing for ‘mild’!

It goes on like that, and he also co-authored a 25,000-word review of mask research, if you're really, really interested in the topic.

P.S. Massachusetts cases were up four tenths of a percentage point today.

Day 656: Pfizer Can’t Count

Alex Berenson notes that Pfizer's COVID vaccine trial data has been mysteriously updated to include more deaths, with a notable increase among the vaccinated rather than the controls:

Pfizer said publicly in July it had found 15 deaths among vaccine recipients by mid-March. But it told the FDA there were 21 - at the same data cutoff end date, March 13.

21.

Not 15.

The placebo figure in the trial was also wrong. Pfizer had 17 deaths among placebo recipients, not 14. Nine extra deaths overall, six among vaccine recipients.

Could the discrepancy result from some odd data lag? Maybe, but the FDA briefing book also contains the number of Covid cases that Pfizer found in vaccine recipients in the trial. Those figures are EXACTLY the same as those Pfizer posted publicly in July.

Yet the death counts were different.

Pfizer somehow miscounted - or publicly misreported, or both - the number of deaths in one of the most important clinical trials in the history of medicine.

And the FDA’s figures paint a notably more worrisome picture of the vaccine than the public July numbers. Though the absolute numbers are small, overall deaths were 24 percent higher among vaccine recipients.

The update also shows that 19 vaccine recipients died between November and March, compared to 13 placebo recipients - a difference of almost 50 percent.

Sadly, the mystery of the missing deaths may not be solved until 2076, if Pfizer has anything to say about it.

Against the New York Times' advice, I went down this rabbit hole and found something rather different, a report challenging the CDC's assurances that mRNA vaccines are safe in pregnancy. The article disappeared from ResearchGate sometime this week (see the wayback machine version), but is still around at the bottom of the rabbit hole:

The use of mRNA vaccines in pregnancy is now generally considered safe for protection against COVID-19 in countries such as New Zealand, USA, and Australia. However, the influential CDC sponsored article by Shimabukuro et al. (2021) used to support this idea, on closer inspection, provides little assurance, particularly for those exposed in early pregnancy. The study presents falsely reassuring statistics related to the risk of spontaneous abortion in early pregnancy, since the majority of women in the calculation were exposed to the mRNA product after the outcome period was defined (20 weeks’ gestation). In this article, we draw attention to these errors and recalculate the risk of this outcome based on the cohort that was exposed to the vaccine before 20 weeks’ gestation. Our re-analysis indicates a cumulative incidence of spontaneous abortion 7 to 8 times higher than the original authors’ results (p < 0.001) and the typical average for pregnancy loss during this time period. In light of these findings, key policy decisions have been made using unreliable and questionable data. We conclude that the claims made using these data on the safety of exposure of women in early pregnancy to mRNA-based vaccines to prevent COVID-19 are unwarranted and recommend that those policy decisions be revisited.

Which is to say, the CDC can't count, either.

P.S. Massachusetts cases were up a third of a percentage point today.

Day 655: COVID as Mass Hysteria

I have no doubt that COVID-19 is the greatest threat to humanity we have ever faced; not because of a virus; … but because of our response to it.

Fired ethicist Professor Julie Ponesse

Technically, today's topic is Mass Formation rather than mass hysteria (h/t Mark Wauck), but that only makes it worse:

Free-Floating Anxiety is the most painful psychological phenomena to experience and leads to panic attacks. In this state of unfocused anxiety the mind tries to connect it’s anxiety to something, an “Object of Anxiety”. The next piece of the puzzled is a strategy to deal with this Object of Anxiety.

So when these pre-conditions are highly present within a population and then the media provide a narrative which indicates a focal-point for this anxiety while at the same time describing a strategy to deal with this object of anxiety then all the anxiety connects to this object of anxiety.

If a large segment of people are willing to follow this strategy to deal with this object of anxiety no matter the cost, then in a second step people start a collective & heroic battle with this Object of Anxiety and in that way a new kind of social bond emerges & with that a new kind of “sense making” or purpose. Suddenly life is all directed towards battling this Object of Anxiety. This creates new sense of connectedness with others in the Mass-Formation.

In other news, New Jersey reports a mysterious increase in MIS-C cases among children in the past week. COVID cases didn't rise, so it's a complete mystery what could have happened. The article suggests "variability" or "luck" to explain "the biggest jump in a week that we’ve had in quite some time."

PlagueBlog suspects Mass Formation may be a factor, as there are already 43 or 44 reports of MIS-C associated with COVID vaccines in VAERS this year, and only two other reports, ever, for other vaccines. (One of the 44 reports is significantly typoed but is clearly about COVID, just not so clearly about a vaccine.)

P.S. There are so many challenges to the federal vaccine mandate that the circuit courts held a lottery to see who'd hear one, and the sixth circuit won. While possibly not as slap-happy as the fifth circuit, it's a relatively conservative court where the mandate may fare ill.

P.P.S. Massachusetts cases were up a quarter of a percentage point today.

Day 653: Slapdowns

This week was big on dissing the vaxx: the Fifth Circuit stayed OSHA's overreaching vaccine mandate, in language that forebodes a final slapdown to come:

On the dubious assumption that the Mandate does pass constitutional muster—which we need not decide today—it is nonetheless fatally flawed on its own terms. Indeed, the Mandate's strained prescriptions combine to make it the rare government pronouncement that is both overinclusive (applying to employers and employees in virtually all industries and workplaces in America, with little attempt to account for the obvious differences between the risks facing, say, a security guard on a lonely night shift, and a meatpacker working shoulder to shoulder in a cramped warehouse) and underinclusive (purporting to save employees with 99 or more coworkers from a "grave danger" in the workplace, while making no attempt to shield employees with 98 or fewer coworkers from the very same threat). The Mandate's stated impetus—a purported "emergency" that the entire globe has now endured for nearly two years, and which OSHA itself spent nearly two months responding to threat). The Mandate's stated impetus—a purported "emergency" that the entire globe has now endured for nearly two years, and which OSHA itself spent nearly two months responding to—is unavailing as well. And its promulgation grossly exceeds OSHA's statutory authority.

A smaller slapdown comes from some Swedish doctors and researchers, who have an extremely anti-vaxx response to recent whistle-blowing documented by the British Medical Journal:

The group’s statement in a November 5 press release came in light of a whistleblower’s testimony to the prestigious British Medical Journal (BMJ), alleging that a Pfizer subcontractor company had falsified data, unblinded trial participants, and neglected the timely follow-up of subjects experiencing adverse events as they conducted a Pfizer COVID-19 vaccine trial in the fall of 2020.

Brook Jackson, a “trained clinical trial auditor” with more than “15 years’ experience in clinical research coordination and management,” worked for Ventavia Research Group of Texas for two weeks in September 2020 and was fired the day she raised her concerns to the U.S. Food and Drug Administration (FDA).

It's starting to look like an Ayn Rand novel around here...

Day 651: Armchair Epidemiologists

Today's title refers not to semi-qualified disease bloggers such as infest PlagueBlog Headquarters, but to completely unqualified heads of state who feel the need to override their dedicated health bureaucracies in order to prescribe, say, COVID boosters for all without a license. The latest entry in this scarily overcrowdyed space is Colorado Governor Jared Polis, who's declared a booster free-for-all for his state because he doesn't like their case rate.

Mr. Polis’s order justified broadening access to boosters by saying that since the entire state of Colorado has seen significant spread of the virus, it qualified as the kind of high-risk environment for which federal regulators cleared boosters.

Sure it is...

P.S. Massachusetts' approximate case rate (due to yesterday's holiday) was two ninths of a percentage point.

Day 650: Russia Sets Records

Russia edged out the US last week with 200 more deaths (for the week), according to the Moscow Times. Russia's overall numbers have gotten a lot of attention, but rates are rising all over Europe. Heavily vaccinated Germany hit 50,000 new cases in one day today. The Netherlands also broke records with 16,000 new cases today. Their neighbors aren't doing any better; central Europe is particularly hot.

While we're looking at the numbers, it's worth noting that the world has exceeded 250 million cases and 5 million deaths from COVID-19. Massachusetts is currently 18th in total cases in the US, with Missouri hot on our tail.

P.S. The MDPH took the holiday off.

Day 648: Where in the World is Gavin Newsom

COVID isn't all sniffles and anosmia; sometimes it's fun and games, like when the First Partner [sic] of California Governor Gavin Newsom lashes out on Twitter over uppity speculation from the peanut gallery about why he hasn't been doing his job for over a week now. After his last public appearance receiving a booster shot on October 27th, he cancelled on a climate change conference in Scotland and didn't even attend virtually. Rumor placed him at a Getty heir's wedding at San Francisco city hall this weekend, but he did not attend the reception.

P.S. Massachusetts cases were up two elevenths of a percentage point today.

Day 644: Three Deaths in Thailand

The Bangkok Post has an interesting story about three deaths from unspecified COVID vaccines. The interesting part is that there were another 100 or so deaths where the vaccine couldn't be ruled out, out of the 842 deaths examined so far. (The numbers in the article don't quite add up, perhaps because the categories of death did not quite translate.)

On his own death watch, eugyppius mocks the UK's health agency dancing around another week of the vaxx is worse than the disease statistics. He predicts the politicians will just force them to stop publishing the numbers soon.

P.S. Massachusetts cases were up a fifth of a percentage point again today.

Day 643: More Original Antigenic Sin

There's a rather odd paper in Clinical Immunology Communications about original antigenic sin, antibody dependent enhancement, and back boosting. While it's a great description of those mechanisms and their history in other coronaviruses, it provides no data or citations about their role in COVID-19, only theoretical possibilities. So it's particularly jarring that they conclude on the basis of nothing at all that OAS and ADE have played no role in undermining the success of the vaccines:

Conclusions and perspectives

From the data thus far, there are no indications that the current SARS-CoV-2 vaccines lead to ADE or that the effectivity would be impaired because of the OAS. Yet, sometimes (social) media reports hint towards a higher risk of SARS-CoV-2 infection following vaccination. Furthermore, the concepts of OAS and ADE should be kept in mind when vaccines against novel SARS-CoV-2 variants are developed and tested, and the same would hold true for pan-coronavirus vaccines.

It should be realized that the effects of OAS not necessarily are negative, under some circumstances it can be beneficial because it can offer protection against antigenically related virus strains. Especially the back boosting aspect of OAS can have a relative protective effect when novel virus variants emerge, such as has been shown for influenza.

Speaking of side-effects, there's also a paper out about myocarditis in recently-vaccinated adolescent males who had received an mRNA-based vaccine and had not had a prior case of COVID:

Of 52 patients who underwent cardiac MRI during the study period, 5 underwent MRI for suspected myocarditis after recent COVID-19 mRNA vaccination without known prior COVID-19. These 5 patients were all males with age ranging from 16 to 19 years (mean, 17.2±1.0 years) who presented within 4 days of the second dose of COVID-19 mRNA vaccine. Troponin levels were elevated in all patients (mean peak troponin I, 6.8±4.1 ng/mL). Alternate possible causes of myocarditis were deemed clinically unlikely based on medical history, physical examination, myocarditis viral panel, and toxicology screen. Cardiac MRI findings were consistent with myocarditis in all 5 patients based on Lake Louise criteria, including early gadolinium enhancement (EGE) and late gadolinium enhancement (LGE) in all patients and corresponding myocardial edema in 4 patients. All 5 patients had a favorable hospital course and were discharged in stable condition with improved or resolved symptoms after mean hospitalization length of 4.8 days. Two patients underwent repeat cardiac MRI that showed persistent, though decreased, LGE. Three patients reported mild intermittent self-resolving chest pain after discharge; 2 patients had no recurrent symptoms after discharge.

That's practically the entire paper, but there's some interesting speculation on Reddit about what the mechanism might be.

Massachusetts cases were up a sixth of a percentage point yesterday, and [p.s.] a fifth today.

Day 641: Vitamin D Again

A meta-analysis of "much" COVID vs. calcidiol research concludes

Results: One population study and seven clinical studies were identified, which reported D3 blood levels preinfection or on the day of hospital admission. The two independent datasets showed a negative Pearson correlation of D3 levels and mortality risk (r(17) = -0.4154, p = 0.0770/r(13) = -0.4886, p = 0.0646). For the combined data, median (IQR) D3 levels were 23.2 ng/mL (17.4-26.8), and a significant Pearson correlation was observed (r(32) = -0.3989, p = 0.0194). Regression suggested a theoretical point of zero mortality at approximately 50 ng/mL D3.

Conclusions: The datasets provide strong evidence that low D3 is a predictor rather than just a side effect of the infection. Despite ongoing vaccinations, we recommend raising serum 25(OH)D levels to above 50 ng/mL to prevent or mitigate new outbreaks due to escape mutations or decreasing antibody activity.

If you're curious about how much vitamin D you can take, here's some unintentional advice from the Mayo Clinic:

The main consequence of vitamin D toxicity is a buildup of calcium in your blood (hypercalcemia), which can cause nausea and vomiting, weakness, and frequent urination. Vitamin D toxicity might progress to bone pain and kidney problems, such as the formation of calcium stones.

Treatment includes stopping vitamin D intake and restricting dietary calcium. Your doctor might also prescribe intravenous fluids and medications, such as corticosteroids or bisphosphonates.

Taking 60,000 international units (IU) a day of vitamin D for several months has been shown to cause toxicity. This level is many times higher than the U.S. Recommended Dietary Allowance (RDA) for most adults of 600 IU of vitamin D a day.

A less authorotative but more detailed source puts the dangerous dose somewhere between 40,000 and 100,000 units a day (although the latter dose was proven safe in pregnancy).

Euggyppius strikes again, with a nice graph of case rates being higher in the vaccinated over 30 in England:

I had to make the graph myself, because they’re not publishing it anymore. Instead, we just get the tables, which they’ve festooned with hilarious disclaimers pleading that these numbers are “unadjusted,” by which they mean “inconvenient.”

CNN reports that the CDC is deciding today whether to jab the children. (A pro-forma approval from the director is to be expected after that.) Pfizer has the vials in place already.

Perhaps the Commonwealth will release case numbers today, but no promises...

P.S. Massachusetts cases were up a seventh of a percentage point.

Day 635: Original Antigenic Sin

Not surprisingly, the FDA ruled yesterday to authorize Pfizer's experimental (in children) vaccine for healthy children 5–11 years of age who are statistically at no risk from COVID-19. It may seem like the only risk to children is from side-effects of the vaccine itself, but vaccinating against harmless, variable diseases is in fact counter-productive due to original antigenic sin:

Original Antigenic Sin was most influentially described by Thomas Francis in 1960. He noted that, regardless of whatever influenza A strains were in circulation, subjects tended to have dominant antibody responses to the strains that were current in their early childhood:

The antibody of childhood is largely a response to … the virus causing the first Type A influenza infection of the lifetime. As the group grows older and subsequent infections take place, antibodies to additional families of virus are acquired. But … the antibody which is first established continues to characterize that cohort of the population throughout its life. The antibody forming mechanisms have been highly conditioned by the first stimulus, so that later infections with strains of the same type successively enhance the original antibody to maintain it at the highest level at all times in that age group. The imprint established by the original virus infection governs the antibody response thereafter. This we have called the doctrine of original antigenic sin.

An important consequence of this childhood conditioning, is that different age cohorts within the population have overlapping or layered immunity to different influenza strains. This is an important if subtle aspect of our population-wide immunity to influenza A.[...]

The most dangerous thing to do, at this point, would be to vaccinate children. The virus is not a threat to them, and if they are infected by the new forms of SARS-2 that are sure to emerge every winter, we will begin to establish – through them and the as yet unvaccinated – the layered immunity that is the only way of coming to terms with SARS-2 in the longer term. As long as the vaccinators are permitted to continue their radical and increasingly insane campaign, though, nothing will improve. Indeed, their policies threaten to bring about a semi-permanent pandemic state for generations to come.

Read the whole thing for lessons learned from dengue fever and why the flu vaccine doesn't work, yet appears to help at the epidemiological level, and check out the rest of eugyppius' substack.

Massachusetts cases were up a sixth of a percentage point again yesterday.

P.S. When finally reported, cases were up a sixth of a percentage point.

Day 633: Spikevax Spiked Again

Despite the local enthusiasm for Moderna boosters, Sweden, land of the old normal, continues to diss the Spikevax, extending their under-30's Moderna moratorium beyond the initial December 1st deadline.

Things aren't all rosy for Pfizer, either. Lawyers for the de Garay family are agitating against Comirnaty in children. In their letter to the FDA and CDC they say:

To date, Pfizer’s Comirnaty is approved for children ages 16 and 17 and authorized for emergency use in children 12 through 15, with authorization expected shortly for children 5 through 11. Before any additional authorizations or approvals for children are granted, it is imperative that you properly account for what occurred to Mr. and Mrs. de Garay’s 12-year-old daughter, Maddie, in Pfizer’s clinical trial.

The only rigorous way to ensure safety and efficacy is via appropriate clinical trials which do not ignore serious adverse events occurring in those trials. Pfizer’s clinical trial for children aged 12-15 included 2,260 participants, half of who received the vaccine and half who received a placebo. Meaning, only 1,131 children were vaccinated and at least one of those children, Maddie de Garay, suffered a devastating, life-altering injury which, despite incontrovertible proof and the cries of both the victim and her parents, has not been acknowledged by the sponsor (“Pfizer”) or the Food and Drug Administration (“FDA”).

For a virus for which children have a 99.998% chance of surviving, the FDA must ensure there is an even more remote chance of a serious adverse event from any vaccine intended to prevent harm from the virus. Therefore, we implore you to carefully consider the following information.

Massachusetts cases were up a sixth of a percentage point on Friday.

Day 629: Delta 13 Pro Max 5G

MSN has some details about the rumored Delta variant variant known as Delta Plus, AY.4.2, not to mention sillier names (h/t Reddit). It doesn't sound particularly newsworthy:

“We need urgent research to figure out if this delta plus is more transmissible, has partial immune evasion,” Gottlieb said in a tweet.

“There’s no clear indication that it’s considerably more transmissible, but we should work to more quickly characterize these and other new variants. We have the tools.”

P.S. Massachusetts cases were up a sixth of a percentage point.

Day 628: Out-N-Out

The local CBS affiliate reports that the only San Francisco In-N-Out Burger joint was temporarily shut down by the city's Department of Public Health (SPDPH) for failing to check customers' vaccination status, and is now restricted to take-out only. Corporate expressed an interesting take on private enforcement of state mandates:

The company’s Chief Legal and Business Officer Arnie Wensinger said in a statement that the location “properly and clearly posted signage to communicate local vaccination requirements.”

However, Wensinger’s statement went on to disagree with the SFDPH requirement that restaurant employees “must actively intervene by demanding proof of vaccination and photo identification from every customer, then act as enforcement personnel by barring entry for any customers without the proper documentation.”

The statement said that the company believes in serving all restaurant customers and making all feel welcome, and said the company would not comply what it called the requirement to act as “vaccination police.”

“We refuse to become the vaccination police for any government. It is unreasonable, invasive, and unsafe to force our restaurant associates to segregate customers into those who may be served and those who may not, whether based on the documentation they carry, or any other reason,” the statement read. “We fiercely disagree with any government dictate that forces a private company to discriminate against customers who choose to patronize their business. This is clear governmental overreach and is intrusive, improper, and offensive.”

In more disturbing news, Reuters reports that the White House is out ahead of the science again, preparing for Pfizer jabs for 5–11-year-olds that haven't been approved yet:

[U.S. Surgeon General Dr. Vivek] Murthy said the administration was not looking to get ahead of health regulators but wanted to lay the groundwork to ease distribution to ensure there is ample supply and access to vaccination locations.

PlagueBlog's response to this rush to administer an experimental vaccine to children at no statistically significant risk from the uncommon cold comes from the offGuardian's Monday morning meme series:

P.S. Massachusetts cases were up two elevenths of a percentage point today.

Day 627: Mix'n'Match

Without citing any evidence, The New York Times reports that the FDA is planning to permit boosting with a different vaccine later this week:

Federal regulators this week are aiming to greatly expand the number of Americans eligible for booster shots. The F.D.A. is expected to authorize boosters of the Moderna and Johnson & Johnson vaccines by Wednesday evening; it could allow the mix-and-match approach by then. The agency last month authorized booster shots of the Pfizer-BioNTech vaccine for at least six months after the second dose.

An advisory committee of the Centers for Disease Control and Prevention will take up the booster issue on Thursday; the agency will then issue its own recommendations. By the end of the week, tens of millions more Americans could be eligible for extra shots.

They don't seem to think the list of boostable people will be changing from prior reports: all adult Johnson & Johnson recipients, plus at-risk Moderna recipients presumably matching the Pfizer booster candidates.

CNBC reports Southwest has backed down on their vaccine mandate deadline. Employees will now go on working while their exemption requests are processed.

P.S. Massachusetts cases were up a quarter of a percentage point.

Day 626: Withdrawn Article in Press

Longtime vaccine researcher and blogger, Dr. Meryl Nass, notes the disappearance of an article about vaccine-induced myocarditis from Science Direct/Current Problems in Cardiology. A copy can be found at archive.is, and the non-reason for taking it down can be found at Science Direct:

The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.

The late, lamented article was a rather simple and unobjectionable analysis of the VAERS data on the subject:

Following the global rollout and administration of the Pfizer Inc./BioNTech BNT162b2 and Moderna mRNA-1273 vaccines on December 17, 2020, in the United States, and of the Janssen Ad26.COV2.S product on April 1st, 2021, in an unprecedented manner, hundreds of thousands of individuals have reported adverse events (AEs) using the Vaccine Adverse Events Reports System (VAERS). We used VAERS data to examine cardiac AEs, primarily myocarditis, reported following injection of the first or second dose of the COVID-19 injectable products. Myocarditis rates reported in VAERS were significantly higher in youths between the ages of 13 to 23 (p<0.0001) with ∼80% occurring in males. Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males. A total of 67% of all cases occurred with BNT162b2. Of the total myocarditis AE reports, 6 individuals died (1.1%) and of these, 2 were under 20 years of age - 1 was 13. These findings suggest a markedly higher risk for myocarditis subsequent to COVID-19 injectable product use than for other known vaccines, and this is well above known background rates for myocarditis. COVID-19 injectable products are novel and have a genetic, pathogenic mechanism of action causing uncontrolled expression of SARS-CoV-2 spike protein within human cells. When you combine this fact with the temporal relationship of AE occurrence and reporting, biological plausibility of cause and effect, and the fact that these data are internally and externally consistent with emerging sources of clinical data, it supports a conclusion that the COVID-19 biological products are deterministic for the myocarditis cases observed after injection.

PlagueBlog eagerly awaits the return of the article.

Massaschusetts cases were up about a tenth of a percentage point daily over the weekend.

Day 623: Johnson & Johnson & Johnson

Yesterday's rubber-stamp-happy FDA committee are still in session; today they approved boosters for Johnson & Johnson's COVID vaccine, for all the unfortunates previously vaccinated with their one-shot non-mRNA regimen. The recommended delay after an initial dose is two months; most people are well past that by now. The doubts about Moderna PlagueBlogged earlier this week also apply to this decision:

Days before the meeting Friday, FDA scientists published an analysis on J&J’s application for a booster, questioning the strength of the data. The FDA said people may benefit from a second dose, but added the information provided by the company was limited and the agency hadn’t verified all of it yet. It acknowledged a single J&J dose was consistently less effective than the mRNA vaccines in clinical trials and in real-world studies.

Before the vote, some committee members asked the FDA whether they could postpone a decision on boosters, saying it may be too early as there are still a number of outstanding questions. Other members wondered why the agency brought J&J’s application before the committee before it was able to verify all of the data.

P. S. Massachusetts cases were up a fifth of a percentage point today.

Day 622 Retrospective: Spikevax Bounces Back

Yesterday, despite the lack of evidence, the FDA committee of 19 voted unanimously in favor of distributing Moderna's half-strength Spikevax booster to the usual suspects, "including the elderly, adults with underlying medical conditions and those who work or live in high-risk settings, such as health-care and grocery workers." One member was particularly honest about the state of vaccine science at the FDA these days:

When the FDA committee met last month, they rejected a proposal to distribute booster shots of Pfizer and BioNTech’s vaccine to the general public. Some committee members at the time said they were concerned there wasn’t enough data to make a recommendation, while others argued third shots should be limited to certain groups.

After Moderna’s unanimous vote Thursday, committee member Dr. Patrick Moore said the data the company submitted for authorization of a booster “was not well explained,” adding he voted yes more on “gut feeling.”

“The data itself is not strong, but it is certainly going in a direction that is supportive of this vote,” he said.

Massachusetts cases were up two ninths of a percentage point yesterday.

Day 621: Spikevax Spiked Some More

There's been some snide "fact checking" in the mainstream media over hasty alt-press reports that Sweden had banned Moderna's vaccine outright rather than just for young adults [under 30]. On the other hand, Iceland has abandoned Spikevax altogether as of last Friday. The following is a slightly corrected Google translation of that link. Note the Epidemiologist's comments on neighboring countries' policies.

Use of the COVID-19 vaccine Moderna in Iceland

In recent days, there has been data from the Nordic countries on the increased incidence of myocarditis and pericarditis after vaccination with Moderna vaccine in addition to [sic] vaccination with Pfizer/BioNTech (Comirnaty).

In Sweden, the use of Moderna has been restricted to individuals born before 1991. In Norway and Denmark, it has been emphasized that Pfizer vaccines are recommended rather than Moderna vaccines for 12–17 year olds.

In Iceland, only the Pfizer vaccine has been recommended for primary vaccination at 12–17 years of age since vaccination of this age group began.

For the past two months, Moderna vaccines have been used almost exclusively for booster vaccinations after the Janssen vaccine and after two-dose vaccinations for the elderly and immunocompromised. Very few individuals have received the second dose of primary vaccination, which started with Moderna.

As there is a sufficient supply of Pfizer vaccine in Iceland for both the pre-vaccine activation vaccines and the primary vaccinations of those who have not yet been vaccinated, the Epidemiologist has decided not to use the Moderna vaccine in Iceland, while providing further information on the safety of the Moderna vaccine vaccine.

—Epidemiologist

There's a bit more information about the history of Moderna in Iceland in this alt-press article.

Domestically, the FDA dissed Moderna this week, as the advisory panel punted on their boosters (as well as Johnson & Johnson's), due to concerns about insufficiently increased efficacy:

Moderna said the mean antibody level of participants in its study was 1.8 times higher after the booster than it was after the second shot. In another measurement, the booster raised neutralizing antibodies at least fourfold in 87.9 percent of people compared to after the second dose, thus narrowly failing to meet the agency’s requirement of 88.4 percent.

The EMA also has yet to rule on Moderna boosters. To some extent Moderna is suffering from its greater initial efficacy, which may be due to their higher dose (the booster is proposed to be only half-strength) or the longer delay between initial shots, or both.

It's not recommended to boost with a different vaccine than initially administered (e.g., Pfizer's approved Comirnaty booster) even though there have been some reports that varying the vaccine administered increases overall efficacy. So the Spikevaxxed are out of luck unless they fall under the exemption for the immunocompromised. Nevertheless, the New York Times estimates that 1.5 million of the Spikevaxxed have gotten boosted (with a full dose) by hook or by crook. (PlagueBlog does not recommend illicit boosting.)

While normally the FDA would be ruling in line with the advisory panel's decision come Thursday, the New York Times has some frightening things to report about the temptation "to reach 'a harmonized approach' for all three vaccines and to simplify booster recommendations for the general population." PlagueBlog does not recommend purely political boosters.

P.S. Massachusetts cases were up a fifth of a percentage point today.

Day 620: You Are Not Free to Move About The Country

Southwest Airlines is experiencing a miraculous new phenomenon of airline-specific weather delays. While the more willingly vaccinated (or at least more reliably staffed) airlines continued to fly over the holiday weekend, some Southwest-specific dark clouds grounded hundreds of their flights.

The MDPH was merely sleeping on the job last week, not giving up daily reporting, and the numbers have now appeared (sans apology) on the website. Of course Monday was a holiday, so the best I can give you is an increase in cases of two ninths of a percentage point as of last Friday.

P.S. Here's an article with a Southwest pilot's perspective on the "weather" situation.

Day 616: Sweden Strikes Again

It sounds like anti-vaxx propaganda, but it is the case that Sweden has halted the use of SpikeVax for young people [under 30] due to complications (myocarditis and pericarditis). Similarly, in Denmark and Norway only Comirnaty is given to teens, and is recommended for young males up to 30.

The CDC has not noted such an advantage of Pfizer over Moderna in the case of these complications; it seems that Johnson & Johnson is the way to go for that age group (though their European analogue doesn't see it that way).

This week the state stopped reporting daily numbers, even though cases were up a fifth of a percentage point last Friday. (Apparently the MDPH is suffering from COVID fatigue.)

Day 580: Long, Long, Long COVID

The rationalists are out in force on the controversial topic of Long COVID. Scott Alexander summarized the definitional chaos overnight, and Zvi summarized the meta impact on the COVIDosphere (as it were) today.

While Zvi continues to disbelieve in long COVID as anything more than just another long flu, and notes that a society-wide epidemic of depression and other mental illness is hiding (in plain sight) in the long COVID control group data. Scott, on the other hand, gives it too much credit by calling it a long Spanish Flu, though he agrees there's probably little to no long COVID in children. He also mentions that, otrangely, vaccination does not reduce the rate of long COVID in the infected.

PlagueBlog sides with Zvi; the only thing we need to fear is the fear of long COVID itself:

I agree with Scott’s view here that our worries about Long Covid strongly imply the need for more worry about Long Disease in general, and also Long Everything. The previous Aceso Under Glass post emphasized this point, that there’s lots of such risks in the background all the time, and this isn’t an especially big one.

More to the point, Long Covid Prevention has clearly reached crisis levels and really is a big deal, and seems more severe than Long Covid, and a huge percent of the population has this problem, so we need to do what it takes to stop this deadly syndrome in its tracks.

Massachusetts cases were up about a quarter of a percentage point again today.

Day 579 Retrospective: The Week That Dare Not Speak Its Name

It's been a summer of snarky remarks about orgies at Market Basket here at PlagueBlog Headquarters, but reading about Bear Week at Less Wrong reminded us that we have not properly blogged about the Provincetown delta scare that never was. It's perhaps too obvious here in Massachusetts what's going on in Provincetown all summer, but to the CDC a few non-fatal cases of delta during Bear Week has become an excuse to doubt the vaccine and send the nation back under the mask.

Bear Week was cancelled last year and (allegedly) toned down this year, but the bears still got an early start to it over the Fourth of July weekend and continued to party during the official dates of July 10th through the 18th. The CDC study's outbreak dates were July 6th through 25th, and their patient population was 85% male, or in other words, sick bears.

Believe it or not, the CDC's total failure to account for what we in the epidemiology field abbreviate MSM was not the only problem with the Provincetown study, nor was the other MSM's (mainstream media's) failure to report that it was Bear Week. Zvi at Less Wrong goes into more detail about the flawed report here and here.

From the second link, we must include Zvi's unrelated summary of our new social media COVID Stasi censors:

It’s about the new definition of misinformation, which as far as I can tell is information used to lead to a conclusion we don’t like.

Massachusetts cases were up a quarter of a percentage point again yesterday (Day 579).

Day 578: SpikeVax or StrikeVax?

Here at PlagueBlog we intended to report on the extra-metalness of SpikeVax, now shown to make twice as many antibodies as the less-metal-named Comirnaty. But the news overtook us that two vaccine leaders are leaving the FDA, apparently in protest of the Biden administration's recent foray into deciding who should get boosters and when.

A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.

FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”

Here in Massachusetts, cases were up almost a fourth of a percentage point today, after a dip down to a fifth daily since Thursday's high.

Day 574: Kids Still Unaffected

Despite some hand-wringing at The Atlantic, children remain statistically unaffected by COVID. Emily Oster (perhaps best known for Cribsheet: A Data-Driven Guide to Better, More Relaxed Parenting, from Birth to Preschool) has been blogging about the data to the end of reassuring freaked-out parents. As of her latest post, COVID is still barely even the flu for children:

The million dollar question: Does Delta change this? It is not completely clear. People, including the CDC Director, have cited more hospitalizations among children in heavily affected areas as evidence that Delta might be worse for kids. However, with more cases, we expect more hospitalizations. We saw this rise in pediatric hospitalizations last winter, as well, without Delta. Seeing more cases is different from saying that delta increases the hospitalization rate. There is also an increase in RSV in young children in many of the same areas COVID is spreading widely, complicating the analysis.

I would argue, though, that what we do know suggests the risks are in the same range. That the narrative that this is a new virus which is tremendously more dangerous for children is just simply not supported by the data.

Massachusetts cases were up a quarter of a percentage point yesterday, our biggest one-day jump since mid-April.

Day 570: Comirnaty

As rumored, the FDA approved Pfizer's COVID vaccine, Comirnaty, today, but only the first two jabs for those over 15. The rest of the protocol remains experimental, as does Moderna's far more pronounceable SpikeVax. The side effects of myocarditis and pericarditis, mainly in boys, got special attention.

P.S. Massachusetts cases were up about a seventh of a percentage point on Monday. (This number is derived from the merged weekend data and not indicative of much.)

Day 566: Vexxed by the Unvaxxed

One-time skeptic and ongoing editor-in-chief of Skeptic magazine Michael Shermer recently wrote an article for Quillette about how vexxed he is by vaccine skeptics. After confessing to scolding an employee for her skepticism, he goes into the usual irrelevant risk analogies (yes, the vaccine is less risky than driving, but so is COVID itself), superficial political analysis (no, being pro-life doesn't automatically make you pro-vaxx anymore than it makes you anti-death-penalty), and conflation of vaccination against diseases of childhood with mass adult vaccination against a disease that barely affects children. Vaccine reluctance was summed up much better by a commenter (aptly pseudonamed Sane World):

There may be a fourth reason, not mentioned by the author, why people hesitate to get vaccinated. After the numerous drastic coercive measures of the last twenty months, many of which were previously unknown in liberal western democracies, some people may simply be tired of constantly being persuaded, exhorted, pressured, lied to, incited, coerced, bullied, humiliated, denounced, threatened, criminalized, and punished into submission to an increasingly totalitarian mode of government.

On the irony front, the governor of Texas has come down with COVID. Despite having just tested positive, being vaccinated, and showing no symptoms, he's being treated with Regeneron.

Massachusetts cases were up to a new local high of a fifth of a percentage point yesterday. Our governor remains uninfected.

P.S. Cases were up a fifth of a percentage point again on Thursday, and rumor has it that the Somerville city council Board of Health voted to put us back under the mask (indoors).

Day 563 Retrospective: Booster Shots

The New York Times reports that the Biden administration [sic] is recommending a booster shot of all three US vaccines after 8 months. At least they're waiting for the FDA to approve such a move, but it's unclear why a more relevant agency (the CDC, or at least the Surgeon General) is not doing the recommending. PlagueBlog would prefer medical advice on the matter as opposed to political advice, nor are we the only ones with doubts:

The regulatory path for additional shots is not entirely clear. Pfizer-BioNTech filed data to the F.D.A. on Monday that it said showed the safety and effectiveness of a booster shot. But the data was preliminary, from Phase 1 of a clinical trial. Moderna is on a similar track, exploring the safety and efficacy of both a half-dose and a full dose as a third shot.

The World Health Organization has called for a moratorium on booster shots until the end of September, saying available doses should be used to help countries that are far behind in vaccinations. But Israel is already offering third shots to those at least 50 years old.

Massachusetts cases were up a seventh of a percentage point on Monday. Our governor remains anti-mask, but is permitting cities and towns to gin up their own mask requirements.