With rates of severe disease now much lower in children than at the start of the pandemic—due to higher levels of natural immunity and lower rates of severe disease caused by omicron—trials would have needed to enroll hundreds of thousands of children, if not over a million, in order to detect a significant impact of the pediatric vaccine against severe disease. Vaccine companies could have conducted such time-consuming and costly trials, especially if there had been interest in international collaboration. But there was no economic incentive to do so, and every economic incentive not to: Speed, not providing meaningful information to parents and physicians about safety and efficacy, was the priority of U.S. regulatory agencies.

That paragraph comes from an ironically article called “The CDC Is Breaking Trust in Childhood Vaccination” Drs. Leslie Bienen and Tracy Hoeg. The article states:

With its unscientific push to vaccinate all infants and toddlers against COVID, the agency will harm vaccine uptake for more significant diseases.

The authors lament that the pediatric randomized-controlled trials (RCTs):

Did not assess protection from severe disease, hospitalization, or multisystem inflammatory syndrome in children (MIS-C), important outcomes that parents worry about.

Dr. Hoeg, a sports medicine physician, has been discussed previously on SBM for her VAERS dumpster-dive and suggestion that pediatricians weren’t competent enough to distinguish RSV from COVID. Meanwhile Dr. Bienen, a veterinarian and faculty member at the Portland State University School of Public Health, co-authored an article last year titled “The Reassuring Data on the Delta Variant” with Dr. Monica Gandhi. This article falsely claimed that “places that had higher percentages of the Delta variant had lower ratios of hospitalized people to COVID cases”.

Three areas of agreement

While their previous work aged extremely poorly, and the numerous factual errors in their most recent article were exposed by vaccine-advocates (here, here, and here), I will begin with three areas of agreement with Drs. Bienen and Hoeg.

First, I agree that since that severe COVID is mercifully rare in young children, it would take an expensive, time-consuming trial of hundreds of thousands of children, if not over a million, in order to detect a significant impact of the pediatric vaccine against severe disease.

Second, I too have been critical of the CDC in several articles here, writing:

The CDC’s failure to report clear and accurate data about how COVID-19 is affecting children has opened the door to those who wish to minimize its impact by spreading fear, uncertainty, and doubt.

The article by Drs. Bienen and Hoeg is a perfect example of this, and to the extent the CDC is breaking trust in childhood vaccination, they have willing accomplices in contrarian doctors who eagerly amplify every data mishap to minimize COVID’s impact on children.

Third, it’s true that many unvaccinated children have “natural immunity” to COVID. Dr. Hoeg worked hard to make this a reality by spreading rumors about the safety of COVID vaccines and falsely minimizing the virus. Though her most recent article claims “rates of severe disease now much lower in children than at the start of the pandemic”, nearly 300 children are being hospitalized every day, almost matching the Delta peak from last year. Dr. Hoeg has influenced powerful people. She was prominent member of a panel that led to The Florida Department of Health recommending against vaccinating healthy children.

Methodolatry part 1: An impossible, unethical study

With this is mind, I disagree with Drs. Bienen and Hoeg that it is possible or necessary to conduct an RCT of a million children before vaccinating them. I think they know this too.

In my previous article on methodolatry, the inappropriate worship of RCTs alone, I voiced the surprisingly controversial belief that it is much easier to casually request a million-child RCT than to actually run such an RCT. I also described the anti-vaccine technique of demanding impossible RCTs, both to cast doubt on the validity of existing studies and to disparage scientists who actually do this research. “If only lazy scientists enrolled millions of children in a simple RCT of the entire vaccine-schedule lasting the entire human lifespan looking at every possible outcome, my fears about vaccines would be assuaged“, they say in effect.

Drs. Bienen and Hoeg are scarcely different. Though they claim that a trial of a million children would be possible due to unspecified “advances in recruitment methods”, it’s easier said than done to enroll subjects in an RCT during a pandemic. These supposed “advances in recruitment methods” didn’t help an RCT of hydroxychloroquine and azithromycin run by the NIH. It closed after enrolling just 20 patients, or 1% of their goal. I am sure that trial, like the one fantasized by Drs. Bienen and Hoeg, looked great on paper.

Parents are not afraid of COVID the way they were polio. Currently, only 300,000 children younger than 5-years have been vaccinated against COVID in the US. Their hypothetical RCT calls for vaccinating more children than will likely receive the vaccine this year. Think how ridiculous that is. Nonetheless, Drs. Bienen and Hoeg tell their readers that triple this number of children could be enrolled in an RCT, despite their steady and successful campaign to amplify the vaccine’s imperfections and minimize its benefits. Their most recent article, for example, cherry-picked one study from Hong Kong which reported the highest-rate of vaccine-myocarditis by far. It also did not discuss the favorable prognosis of this condition for nearly all children.

Of course, such an RCT would require a massive outreach program and trial infrastructure, with an enormous number of highly-trained coordinators. It would take many years to complete. To get a sense of the logistics involved in vaccine-trials, I encourage you to peruse the 460-page protocol for one of the pediatric vaccine RTCs of just 2,300 children. These trials are extremely complex, and there are many opportunities for things to go wrong. As Drs. Bienen and Hoeg point out, the Pfizer pediatric RCT of 4,500 children had many children drop out before receiving all three vaccine doses. The inevitable hiccups that would occur in study of a million children would be gleefully used as fodder by those who fear monger about vaccines.

Not only would running a million-child RCT would be impossible in a reasonable time-frame, it would also be unethical to allow unvaccinated children to suffer grave harms from the virus. This is why scientists with actual skin in the game unanimously voted to authorize these vaccines:

All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to the question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine when administered as a 2-dose series (25 micrograms each dose) outweigh its risks for use in infants and children 6 months through 5 years of age?”

Had regulators demanded RCTs of a million older children before authorizing vaccines, many more would have suffered, and some would have died before these trials concluded. Doctors who blithely call for such trials are only revealing their ignorance of how RCTs really work and how seriously COVID has impacted some children. However, calling for impossible, unethical RCTs while denigrating the smaller, though still valuable RCTs that have already been done is the entire gimmick for contrarian doctors who spread fear and doubt about vaccination.

Methodolatry part 2: An impossible, unethical study of dubious value

Even if the impossible trial proposed by Drs. Bienen and Hoeg were possible, there’s no reason to believe the extra knowledge it might provide would justify the costs of waiting. Let’s start with what is already known based on RCTs, thus far reported only in company press releases, conducted during the Omicron wave.

  • Pfizer: Pfizer vaccinated 1,678 children ages 6-months to under 5-years in its RCT and found that after a third dose the vaccine was 80.3% effective in preventing symptomatic infection.
  • Moderna: Modera enrolled 6,700 children under 6-years old in its RCT and found the vaccine was 51% effective against symptomatic infection among children ages 6-months to 2-years, and 37% effective among those 2 to 5 years.

While it’s true these studies were small and the vaccine’s protection against symptomatic COVID was middling, as is true for every age group with Omicron, the CDC stated that the vaccines “are expected to provide higher protection against severe disease” in the youngest children. This is a very reasonable supposition. There is robust evidence from observational studies that the vaccine protects all older children against severe disease. As such, it’s not a great stretch to imagine it will similarly protect younger children. We’ll see.

Moreover, the vaccine was safe in the RCTs for younger children, and vaccine myocarditis, which is almost always mild, occurs in about 1 in 400,000 boys ages 5-11 years. While it’s possible a new side effect might emerge in younger children, we already know a lot about these vaccines, despite what Drs. Bienen and Hoeg want their readers to believe. Millions of older children have already been safely vaccinated.

The risks of repeatedly exposing unvaccinated children to COVID seem much greater than the risks of vaccinating them. While all doctors want pristine science, making decisions with less-than-perfect evidence is an everyday part of medicine, and leaving unvaccinated children vulnerable to COVID is absolutely a medical decision. Basically everything I’ve done in my career derives from a less sturdy evidence base than an RCT of a million people. Curiously, it’s only with pediatric COVID vaccination that “pro-vaccine” doctors demand such a large trial. I’ve not seen Dr. Hoeg call for a million-person RCT, or any studies at all, for the treatments she profits from.

Methodolatry part 3: An impossible, unethical study of dubious value that’s not meant to be taken seriously

How and where would a million-child RCT actually be done? How long would it take? Given how quickly the virus spreads and changes, would the results have any utility by the time the study was over? Have they done power calculations to see if meaningful information could be obtained from a smaller study? Should pediatric vaccines be taken off the market until a larger study is done, even if that is many years into the future? What would be the consequences of leaving unvaccinated children vulnerable during this time?

None of the doctors who’ve proposed a million-child RCT seem to have given a moment’s thought to these important questions. They’ve not written a 400-page protocol, or even a 4-page protocol, for their proposed RCT. This is because they don’t expect anyone to actually take them seriously. They know the regulators and pharma executives they criticize have no intention of starting an RCT of a million children, and they have no interest starting such a trial themselves. They know they are calling for an impossible study. And thus the contrivance becomes clear. A million-child RCT is nothing more than a rhetorical device that plays on their readers’ emotions and signals, “this vaccine isn’t necessary, and it hasn’t really been tested“.

While a million-child RCT with years of follow-up would be super duper, we are allowed to believe reasonable things in the absence of massive trials when children’s’ lives are at stake in the middle of a rapidly shifting pandemic. There is a real cost to leaving children vulnerable to an ever-changing virus, which is why pediatricians who actually treat sick children are eager to vaccinate their patients. According to the COVID Data tracker, over 500 children younger than 5-years have died of COVID thus far, and thousands more have been hospitalized, some intubated in the ICU. Hopefully vaccines will limit these numbers moving forward, even though contrarian doctors have done their best to limit their use by pretending that impossible, unethical studies of dubious value would be feasible if only drug companies weren’t so greedy.

Unsurprisingly, neither Dr. Bienen nor Dr. Hoeg has run any RCT of any size themselves. Unsurprisingly, neither of them cares for sick children. Instead, they are part of a cadre of sheltered doctors whose main contribution this pandemic has been to sit on the sidelines, while being omnipresent in the media, making unserious declarations that that amount to, “here’s what I would do if I had any real-world responsibility“. Remember that the next time they demand someone else do an RCT of a million children.

Author

  • Dr. Jonathan Howard is a neurologist and psychiatrist based in New York City who has been interested in vaccines since long before COVID-19.

Posted by Jonathan Howard

Dr. Jonathan Howard is a neurologist and psychiatrist based in New York City who has been interested in vaccines since long before COVID-19.