Children and Vaccines: After FDA’s Emergency Authorization, a Look at the Evidence

In this image from video, Dr. Eric Rubin, left, explains why he will vote to advise the FDA to authorize Pfizer's COVID-19 vaccine for young children during an FDA advisory panel meeting on Oct. 26, 2021. The Epoch Times via FDA

News Analysis

To read the headlines, you’d think the verdict was in.

On Oct. 26, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee recommended the approval of Pfizer-BioNTech’s RNA COVID-19 vaccine for children 5 to 11, under an Emergency Use Authorization (EUA).

On Oct. 29, the FDA issued an emergency authorization based on the committee’s recommendation.

Still, a few small steps remain before vaccines reach a kindergarten near you.

A Centers for Disease Control and Prevention (CDC) advisory panel needs to carry out their own vote on giving kids the vaccine for COVID-19, the disease caused by the Chinese Communist Party (CCP) virus.

CDC Director Rochelle Walensky will then offer her own recommendation after evaluating that panel’s finding.

Assuming these decisions go Pfizer’s way, the path would be clear for the widespread vaccination of young children throughout the United States.

The Biden administration seems confident that the pharmaceutical giant will triumph: on Oct. 20, they released their Fact Sheet on their prospective rollout of the drug, stating that “the Administration has procured enough vaccine to support vaccination for the country’s 28 million children ages 5-11 years old.”

On Oct. 28, Pfizer announced that it had sold 50 million doses of its pediatric vaccine, deliverable by April 2022, to the U.S. government.

“Our planning efforts mean that we will be ready to begin getting shots in arms in the days following a final CDC recommendation,” the Biden administration’s Fact Sheet stated.

The FDA advisory committee’s recommendation was, we were assured, wholly scientific—after debating the evidence, including some results from an ongoing clinical trial of the Pfizer-BioNTech vaccine, panelists voted 17–0, with one abstention, to confirm that the benefits of two-course vaccination outweigh the risks in children 5 through 11.

Yet a few memorable sour notes marred that day’s presentations.

In one widely circulated comment, panelist Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said safety data are still lacking—but “that’s just the way it goes.”

“We’re never going to learn about how safe the vaccine is unless we start giving it,” said Rubin, before adding that knowledge about rare vaccine complications was acquired the same way in the past.

In an email to The Epoch Times, Rubin defended his comments, writing, “The clinical trial of the Pfizer-BioNTech COVID-19 vaccine in children showed no adverse events. All data to date indicate that it is safe. It will prevent the hospitalization of children with severe disease, as it does with adults. The vaccine works, and saves lives.”

Concerns with long-term safety data partly motivated the panel’s one abstention, from Dr. Michael Kurilla of the National Institutes of Health.

Let’s cut through the noise: What exactly is the case for vaccinating young children—and what’s the case against it?

Risks From COVID-19 for Young Children

The risks of death and serious illness from COVID-19 among young children are one key point of contention.

The FDA’s own briefing modeled scenarios for relative risks of serious illness or death from COVID-19 and serious illness or death from just one possible risk—namely, heart inflammation.

Relying on real-world data from individuals 20 years of age or older during the Delta wave, they assumed that the vaccine was 70 percent effective against COVID-19 and 80 percent effective against hospitalization.

In its briefing to the FDA, Pfizer stated that COVID-19 was among the top ten causes of death in children aged 5 to 14 between January and May 2021, referencing an analysis from the Kaiser Family Foundation.

The CDC has noted that over 94 percent of COVID-19 deaths included other comorbidities, with an average of “4 additional conditions or causes per death.”

Citing a Research Letter that analyzed CDC data, Pfizer’s FDA briefing counted 1.8 million cases and 143 deaths related to COVID-19 through Oct. 14, 2021, and 8,622 hospitalizations through Sept. 18, 2021, in children ages 5 through 11—reflecting a vanishingly low risk of serious illness or death in that population.

Notably, while the briefing did not specify how many of the children who died had serious comorbidities, roughly two-thirds of those hospitalized had one or more underlying comorbidity.

Researchers have consistently found that the dangers of COVID-19 to young children are very low.

A Nature study estimating the COVID-19 infection fatality rate (IFR), or the proportion of those who die from infection, found an IFR of just 0.001 percent in children aged 5 to 9—less than one in 100,000.

Risks From the Vaccine

While Rubin told The Epoch Times the clinical trial data did not identify any adverse events in children ages 5-11, the FDA’s own briefing document from Pfizer detailed a few, including 13 cases of lymphadenopathy, or lymph node swelling.

Notably, the trial did not detect any heart inflammation, a concern for young people receiving the vaccine.

However, Pfizer’s FDA briefing document stated that “the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis [heart inflammation] associated with vaccination.”

Some physicians have spoken in favor of administering the vaccines, even to their own young children.

“I am a board certified immunologist. My wife is a pediatric ER physician. I’ve followed #COVID vaccine data in teens & adults, read Pfizer safety/efficacy data in 5-11 year olds & listened to FDA discussion. We will vaccinate our 8 & 11 year old children w confidence & gratitude,” wrote Dr. David Stukus, a professor of Clinical Pediatrics at Nationwide Children’s Hospital on Twitter.

Dr. Leana Wen, a CNN medical analyst and former president of Planned Parenthood, argued in The Washington Post that young children “need vaccines.”

Others have expressed misgivings, based in large part on what they see as insufficient safety data.

“I don’t think children should be vaccinated for COVID. I’m a huge fan of vaccinating children for measles, for mumps, for polio, for rotavirus, and many other diseases, that’s critical. But COVID is not a huge threat to children,” said Dr. Martin Kulldorff, a Harvard University Professor of Medicine, in an interview with Jan Jekielek on EpochTV’s “American Thought Leaders” program.

“It’s not at all clear that the benefits outweigh the risks for children,” Kulldorff later added.

Rep. Andy Harris (R-Md.), a medical doctor who once served as chief of obstetric anesthesiology at the Johns Hopkins Hospital, voiced similar concerns to NTD about vaccine mandates

“Well, we certainly don’t know what the long-term consequences of the vaccine are, because it’s only been a matter of months since children have gotten this vaccine, because of course, the early studies done now nearly a year and a half ago, were done only in adults,” Harris said. “We do know that most children who are not particularly high risk, that the risk of COVID is actually not that high.”

Slowing the Spread?

Given the low rates of serious illness and death among children, a particularly key justification for vaccinating them is reducing the rate of community transmission.

Children, Pfizer’s FDA briefing claimed, are “important reservoirs of SARS-CoV-2 transmission and may become a primary driver of the pandemic in the near future.”

Yet researchers have generally not identified children—particularly young children—as key sources of community transmission.

One observational study in the Journal of the American Medical Association suggests that children up to the age of 9 attending school were not major contributors to COVID-19 spread, although the study’s findings on teenagers were more equivocal.

A 2020 meta-analysis, or analysis of multiple studies, on COVID-19 susceptibility among young children and adolescents concluded that susceptibility was lower in those groups than in adults and offered “weak evidence” that they play a lesser role in population-level transmission.

More recently, a 2021 meta-analysis on COVID-19 transmission clusters concluded that children infected in school “are unlikely to spread SARS-CoV-2 [COVID-19] to their cohabiting family members.”

The FDA seems to concede that preadolescent children are not super-spreaders in its briefing, noting that in schools, “transmission between school staff members may be more common than transmission involving students” and that “there is evidence that SARS-CoV-2 transmission is greater in secondary and high schools than elementary schools.”

What’s more, in the weeks since U.S. schools resumed in-person instruction, many for the first time since the pandemic began, hospitalizations of children with COVID-19 haven’t risen, as one might expect if children are major drivers of transmission.

In actuality, hospitalizations have rapidly fallen according to Department of Health and Human Services data, and as reported by Bloomberg.

Should it continue, this trend would make it even harder to justify vaccination of children 5-11 according to the FDA’s own risk-benefit assessments, most of which are predicated on the COVID-19 incidence and hospitalization rates in early September at or near the peak of the Delta variant surge.

Additionally, new research suggests that vaccinated individuals have the same likelihood of spreading the COVID-19 Delta variant within their households as unvaccinated individuals, raising further questions about the effectiveness of vaccinating children if slowing the spread is a key aim.

With these facts in mind, it seems difficult to state conclusively that vaccinating young children would make much of a difference at all when it comes to COVID-19 transmission.

Money and Influence

The current push for mass vaccination of our children seems to have multiple, often overlapping motivations—some more understandable than others.

For many, genuine concern about illness, hospitalization, and death in young COVID-19 patients is no doubt the predominant factor—particularly after months of media coverage on the dangers of coronavirus, leading viewers of outlets such as CNN and MSNBC to have a less accurate understanding of the COVID-19 death rate than viewers of more conservative outlets such as Fox News and OANN, according to a poll by Rasmussen. And many very well-informed individuals, such as the doctors quoted above, say they intend to vaccinate their children.

At the same time, it’s hard to ignore Big Pharma’s big money and influence.

As mentioned above, the Biden administration has already purchased 50 million of Pfizer’s pediatric doses, which are one third the size of the company’s adult dose.

According to Endpoints, “the cost of these 50 million doses was not initially made available, although the cost of the Pfizer vaccines has steadily risen for the US,” hitting $24 a dose in July 2021 versus roughly $19.50 per dose in July 2020.

Open Secrets reports that Pfizer alone was the 25th largest lobbyist in the United States in 2020, spending over $10.8 million that year alone. (That’s in addition to the $381,930 Pfizer-affiliated individuals donated to Joe Biden’s presidential campaign, the $119,768 such individuals donated to Donald Trump’s campaign, and the $47,869 such individuals donated to Bernie Sanders’ campaign, among many other political donations.)

Yet Pfizer’s lobbying still falls short of the Big Pharma trade group Pharmaceutical Research & Manufacturers of America. That organization was the third largest lobbying group in the United States in 2020, spending $25,946,000 according to Open Secrets.

Patrick Howley of National File has reported that numerous voters on the FDA’s advisory committee have direct Pfizer ties. Gregg Sylvester, for example, was previously the vice president for Pfizer vaccines.

Other motivations seem to go beyond the purely medical and financial.

Control

For the globe-trotting, technocratic class James Burnham identified as the “managerial elite,” power may be an end in itself, with compliance a necessary means to that end.

Thus, in New York City and many other jurisdictions, the vaccine passports that people age 12 and older (though soon, perhaps, 5 and up) need to access indoor restaurants, gyms, and other spaces do not recognize natural immunity as an alternative to vaccination—a policy at odds with how the CDC, the Army, and other entities have approached immunity in the past.

In Israel, meanwhile, individuals who have received “green passes” through vaccination are losing them six months after their vaccine’s second dose, necessitating a booster shot to retain access to many indoor venues. While this policy may arise partly out of doubts about the effectiveness of the vaccine, the drive for compliance doesn’t stop there. Those who have recovered from COVID-19, and can therefore be expected to have natural immunity, are now being required to receive one dose of vaccine to keep their green passes.

Authorities there have not yet stated whether people will need more boosters in the future to retain freedom of movement.

Dr. Jay Bhattacharya, a professor of medicine and health policy at Stanford University, in an interview with The Epoch Times, lay the blame for vaccine policy on deference to experts who seek control.

“Much of American policy has not been conducted by politicians. It’s been conducted by the science class—you know, a class of scientists,” he said.

“And the politicians have essentially said, I’m gonna relegate the powers I have off to these scientists who are advising me, and we’re gonna follow the science, right?”

“What does it mean other than, I’m gonna abdicate my responsibility as a politician to this group of experts, and I’m gonna do whatever these experts say? I think that is not a liberal social order. What that is very different than that. Again, I would call it a biosecurity state aimed at control. Now it has not been as extreme as Australia, but that’s essentially what we’ve had the last 18, 19 months,” Bhattacharya added.

Some college students, representing a group only a few years older than the children now on the path to vaccination, see the role of government or corporate compliance in the campaign for vaccination—including the vaccine mandates common across many universities.

Juliana, a college student at a university that has imposed a vaccine mandate, agreed that there is a dimension of social or political control to the policy.

“I think it’s also pretty significantly just a P.R. move by the university administration, just trying to cater to what the broader culture wants it to comply with,” she said, adding that most of her fellow students unquestioningly comply.

Though Juliana has requested a religious exemption, she feels her institution has deliberately made it difficult to receive such exemptions.

Graham and Noah attend a school with no vaccine mandate—but the students are still encouraged to get jabbed.

“I think the main rationale for emphasizing vaccines at our school is we don’t want to hit a certain number of cases where we all get shut down,” Graham said.

“I think any institution inherently wants more power and more control,” said Noah. “I think they’re trying to push how far they can extend their power over people’s lives.”

Enthusiasts for globalism speak of the need to “build back better,” which means, in part, moving toward a world without borders, whether between nations or between our bodies and a corporatist state. Perhaps this spirit informed Central Bank President Christine Lagarde in saying that “the whole world” needs to be vaccinated, lest COVID-19 “come back to haunt us.”

In this world, little children may not be exempt.