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.)