The Medical Community is Less Gung-ho on Child Vaccines Than You Might Think
The CDC's exuberance doesn't reflect the sentiment of even the FDA's own scientific advisors
Now that the Pfizer-BioNTech Covid-19 vaccine has received Emergency Use Authorization approval for children 5-11 years old, the Biden administration, along with state governments and public health agencies, is rolling out a campaign to encourage parents to inoculate their kids. On the press circuit, CDC Director Dr. Rochelle Walensky has been entirely upbeat about the safety and efficacy of the shot for children, claiming that the vaccine is “91 percent effective against infection,” that “there were no severe events associated with the safety of this vaccine” in clinical trials, and that the risk of side effects for most people amounts to “a sore arm.”
But a number of doctors and scientists, including some who advised the FDA, have been far less sanguine about the risk-benefit calculation.
“The concern is that it’s a new technology,” Dr. Larry Kwak, an oncologist and former FDA advisor who co-wrote an op-ed on the subject, told me. “So the long-term risks, we need to be honest and acknowledge that they’re completely unknown.”
Kwak, along with another of the op-ed’s authors, Dr. Steven T. Rosen, is primarily worried about the possibility of autoimmune disorders. Autoimmune side effects “will clearly be an issue in healthy children with intact immune systems receiving these inoculations,” Dr. Rosen told me.
He described one such case in a vaccinated adult. “I had a patient in remission from blood cancer who developed ITP, a disease where you consume your own platelets, which predisposes you to bleeding,” he said. “He got it from the J&J vaccine. We hospitalized him. That was the first case I'd seen of an immunologic response after the vaccine.”
“I would have great reluctance for my 3 year-old granddaughter to be vaccinated,” he said.
Long-term side effects aren’t the only concern. Dr. Charlie Bennett, who specializes in adverse drug events, told me that if short-term side effects were to crop up, we might not even find out about them, because our national detection system is so outdated. He believes that we’re still using a “twentieth century approach” to vaccine safety, relying on cumbersome and inaccurate systems like VAERS and FAERS.
Complicating the picture still further is the hyper-politicization behind vaccines. Dr. Bennett has been looking into the possibility that the vaccines have been causing miscarriages. “It’s an area of huge concern,” he told me. If it proves to be the case, “that’s a show stopper.” But it’s been difficult to pursue this line of inquiry given the politics around it. “The first thing that happens when you talk about safety is someone calls you an ‘anti-vaxxer,’” he said.
Dr. Rosen shared the concern. “I think there should just be an honest discussion. Right now anyone who speaks is criticized or ostracized,” he told me.
One of the tricky things about assessing the risk side of the vaccine is that there is so much that’s unknown and unknowable that you’re often left speculating or extrapolating from limited data. You don’t have that same problem when you analyze its benefits — yet on that count, too, the picture is far murkier than the one presented by Dr. Walensky.
On October 26, the FDA’s Advisory Committee held a seven-hour discussion on whether to approve emergency use. Though the 18 scientists on the committee nearly unanimously voted in favor of emergency use authorization (one abstained), their concerns on both the risk and benefit sides were substantive and, in some cases, quite grave.
At least three times on the Zoom call, FDA advisors mentioned that 42 percent of children within the age range in question have likely already been infected by SARS Cov-2. That suggests that 42 percent of these kids likely have some measure of natural immunity, and are therefore in less need of vaccination — and maybe in no need of a shot at all. (The New York Times questions this figure.) As Dr. Michael Kurilla of the National Institutes of Health, who was the abstaining vote, told his colleagues, for these naturally protected children, “the question really becomes, does this vaccine offer any benefits to them at all?”
Dr. Cody Meissner from Tufts Children’s Hospital expressed sympathy for parents who are desperate to inoculate their kids because they’re “so frightened — maybe overly so” of the risk of Covid-19. But, he pointed out on the FDA call, “the issue is side effects.” The hospitalization rate for this age bracket for children is very low: 24 out of 100,000 at its height in August, with a death rate of .008 percent (a CDC official on the call compared its severity to the pre-pandemic flu). Out of this small number, Dr. Meissner noted that 68 percent of kids who have been hospitalized with Covid-19 had underlying co-morbidities. If you presume that 40 percent of the 32 percent remaining “may have immunity already, we're getting down to a very small percent of otherwise healthy 6-11 year old children who might derive some benefit. And we simply don't know what the side effects are going to be.”
One might argue that whether or not it provides any direct benefit to these children, the vaccine indirectly benefits everyone by slowing transmission. But that, too, is questionable.
Despite Dr. Walensky’s 91% claim, Dr. Meissner expects that the vaccine is "probably not going to prevent infection.” Dr. Kurilla agreed, saying he doubted that the vaccine will reduce overall cases of Covid. He expects that we’ll see breakthrough cases and “all the same problems that Covid does whether or not they're vaccinated.”
“The argument in favor of, ‘this will lead to herd immunity, and reduce transmission’ — that’s a theoretical possibility; I’ve seen very little data, and in fact most of what I see right now is that regardless of the percentage in terms of vaccination the newer variants seem to be able to pass through the population,” Dr. Kurilla told his colleagues. “So if all we’re focused on is reducing cases in terms of a benefit, I don’t think that’s likely to be realized.”
Certainly in the rare instances in which children who do contract serious cases of Covid-19, the vaccine will benefit them by preventing them from becoming even more critical. But that benefit is likely to wane over time, as new variants emerge against which booster shots are less and less effective, Dr. Kurilla argued. “We are vaccinating with a prototype spike protein that is no longer circulating, so we have to go to higher and higher levels in order to get sufficient potency in terms of neutralization,” he said. “Everyone is focused on Delta right now but Delta is on the decline. We can anticipate that the future variants are going to be more distantly related, and simply boosting, which we're likely to need to do in this population in six months … is going to become harder and harder to do.” Dr. Kurilla even wondered whether the immune response of kids with infections from the Delta strain would be helped or hindered by a shot of a strain that “goes back almost two years.”
Vaccinating children, then, may provide little direct benefit to them, while imposing upon them some unknowable level of risk, yielding an uncertain amount of added protection to the country at large. That’s hardly a slam dunk case for Dr. Walenksy’s assurance to parents that “the benefit of this vaccine so much outweigh the risks of Covid itself.”
“In some ways we’re vaccinating children to protect the adults, and it should be the other way around,” Dr. James Hildreth pointed out on the FDA call. Speaking of the 40 percent of kids who have already been infected, he continued, “if 30 million children already have some form of immunity, they’ve made their contribution to herd immunity already.”
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Lurking behind the vaccine’s approval and the government’s persuasion campaign is the threat, and the reality, of vaccine mandates. California’s Governor Gavin Newsom added the Covid-19 vaccine to the list of required vaccinations for California public schools nearly a month before it received the Food and Drug Administration’s emergency approval. The statewide school mandate will not go into effect until the vaccine is approved on a non-emergency basis, but San Francisco plans to require proof of vaccination for children in the 5-11 year old range to access indoor public spaces well before that.
The costs that school closures have imposed on children came up again and again in the FDA advisors’ discussion. They were in part inclined to approve the emergency authorization use in order to put an end to them. They also argued for the moral imperative of providing the vaccination option to parents with immunocompromised children.
But more than one advisor openly deplored that the vote before them was binary: yes or no. If left to themselves, many of them clearly would have preferred to limit the population of kids the vaccine was approved for. (The FDA representative on the call objected to doing so on “equity” grounds.) Dr. Kurilla would have changed the dosing schedule as well, which he called “sub-optimal.” He believed kids should be getting one shot at most, not two, and that kids with natural antibodies should perhaps be receiving none at all. (The CDC is giving exactly the opposite advice.)
Instead of reflecting that restraint, though, public policy is likely to go in the opposite direction now that the shot has been authorized: toward vaccine mandates. Yet among the FDA advisors, not a word was voiced in favor of such measures. Dr. Meissner said he wants the vaccine to be available to parents as an option, but worried that approving its emergency use would lead to vaccine mandates for kids to attend school. “And I do not agree with that,” he said.