The Covid vaccines are medical miracles. During the pandemic they have been literal life-savers; I’ll never forget the relief I felt after getting that first shot.
Despite the conspiracy theories in some corners of the web or on Fox News, there is simply zero evidence that they are killing people; that they are harming people in large numbers; or that this is all some malicious plot by Big Pharma. There is overwhelming proof that these vaccines prevent serious illness.
Like all medical interventions, though, vaccines can have side effects. And in the case of mRNA vaccines—those from Pfizer/BioNTech and Moderna—there is a small but real risk for young people, especially young males. The need for an evidence-based discussion about the wisdom of requiring boosters is urgent.
But that’s easier said than done.
Over the course of this pandemic, the public has been told that pronouncements from federal health officials represent “the science.” Distinguished medical experts, including some from our nation’s most elite institutions, who have questioned official Covid recommendations and policies—on everything from lockdowns to masking to vaccine mandates—have often been demonized and sometimes silenced.
And so healthy debate about scientifically complicated and morally complex subjects has been shut down, both by censors and by self-censorship.
David Zweig has been one of those rare journalists who, from the start, has challenged the accepted narrative on Covid. He has published a stream of investigations for New York Magazine, the Atlantic, and Wired—from questioning the wisdom of closing schools, to hospitalization metrics, to masking children—that initially were maligned or ignored, only to be accepted by legacy media and acknowledged by health officials months later.
This particular article, which tackles the knotty subject of boosters and myocarditis, is written with his characteristic nuance and rigor. This piece is longer than our usual fare; it’s the kind of deep dive you’d expect from a magazine. I’d recommend saving it to be read over coffee or a glass of wine.
— BW
We have been exceptionally lucky that Covid-19 largely spares the young. This isn’t to say that the virus hasn’t brought tragedy to some families. But we should keep perspective: More children have died or been hospitalized from the flu in many seasons, than have from Covid in each of the past two years.
And yet, for those two years, many young Americans have been robbed of normal schooling and normal interactions with their peers. We have demanded that young people bear the heaviest burden of our policies for the sake of those who are more vulnerable.
Now we risk asking them to sacrifice even more.
Earlier this month, the CDC and the FDA approved Covid vaccine boosters for children as young as 12. (Until recently, only those 16 and older were eligible for a third dose.) Federal officials celebrated this as excellent news. They insist that the key to children’s safety, and being able to resume normal life, is near-universal and, apparently, repeated vaccination. Young people are not merely able to get a third dose. The CDC obliges them to do so with its language “should receive a booster.”
It’s not just the CDC.
There are signs that state and local governments are mandating a third Covid shot for kids as a condition to participate in society. New York state has already upped its guidance, saying that if kids are 12 or older and exposed to a positive individual, only those who are boosted will be allowed to play sports and participate in extracurricular activities; all other kids will be quarantined. Hawaii’s governor said he is planning to require boosters for visitors. Other states are likely to follow suit.
This is unwise—and likely to further diminish the already degraded trust in our governmental institutions and public health authorities.
Before I go any further, let me say the following: The Covid vaccines are remarkably beneficial tools. They’ve saved innumerable lives. And the evidence shows they’ve helped reduce the incidence of severe disease in untold numbers of people.
It is also the case that the mRNA vaccines carry a small but very real risk of a serious side effect—myocarditis, an inflammation of the heart—for young people, particularly males.
Prior to 2021, few had heard of this disease, for which athletic males from puberty through their early 30s are the highest risk group. (Its prognosis ranges from mild and transient to potentially fatal.) Now, everyone is talking about it.
I have been investigating and writing about this topic since June, when I spoke with the lead scientist who produced the seminal Israeli report, which confirmed an alarming rate of the condition of as high as one in 3,000 in young males following vaccination. (The finding buttressed a number of earlier disparate reports in the United States.)
Since then I have reviewed dozens of datasets and studies, and I’ve spoken with epidemiologists, pediatric immunologists, and infectious diseases specialists. If you listen to what these experts say, if you read the largely overlooked documents, and if you actually look closely at the primary data from the CDC and Pfizer, you will find a story of American health agencies’ misleading communications and a myopic policy agenda sometimes at odds with science.
America is an outlier regarding its vaccine policy for young people. Numerous other countries have taken a far more conservative approach. The UK allows a third dose only for 12 to 15-year-olds who have serious medical conditions that put them at high risk or who live with a vulnerable person. Finland has a similar policy for 12 to 17-year-olds. In Ireland no one under 16 can receive a booster. Denmark, Sweden, Japan, and Spain, are among the countries that have approved boosters for adults only. Some countries don’t recommend Covid vaccines for healthy children at all, or just one dose. Norway’s Institute of Public Health, for example, states: “12-15-year-olds already have high protection against a severe disease course after the first vaccine dose.”
Many countries also recognize previous Covid infection—what’s sometimes referred to as “natural immunity”—as the equivalent of at least one dose of vaccine. The U.S. does not. This is significant because the CDC estimates that as of September, well before the Omicron wave, more than 35% of children already had Covid.
Just as official U.S. policy is out of step with much of the West on the cadence of the first two doses for children and on the question of natural immunity, our country is also out of step when it comes to pediatric boosters. That’s why a number of American experts, including some on the FDA’s own advisory committee, have challenged the wisdom of our policy. They have cited both a lack of evidence of boosters’ effectiveness in children and their potential—even if low—for harm.
Monica Gandhi, a doctor and an infectious-disease specialist at the University of California, San Francisco, was blunt in her assessment. “I am not giving my 12 and 14-year-old boys boosters,” she told me.
Dr. Gandhi is not the only expert to publicly state an intention to not comply with the CDC’s recommendation. Dr. Paul Offit is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, a member of the FDA’s vaccine advisory committee, and is considered one the country’s top authorities on pediatric vaccine policy. He recently said that getting boosted would not be worth the risk for the average healthy 17-year-old boy, and he advised his son, who is in his 20s, not to get a third dose.
Just last week, the WHO’s Chief Scientist, Dr. Soumya Swaminathan, said: “There is no evidence that healthy children or healthy adolescents need boosters. No evidence at all.”
And yet, despite the fact that so many other countries are taking a more cautious path; despite the fact that leading American experts are warning against this policy; and despite the recent comments by the WHO’s chief scientist, the CDC and FDA have ignored all of this and gone full steam ahead.
When it comes to green-lighting new vaccines and drugs, there is a way things typically go.
The CDC and FDA each convene a panel of independent experts who vote on vaccine policy. In September 2021, both committees were convened. And both voted against wide-ranging proposals from the agencies for boosters, instead approving the third dose only for limited groups. Notably, these votes were at odds with the Biden administration’s public push for boosters for all.
Only rarely does the head of the CDC act in opposition to its advisory committee. But Dr. Rochelle Walensky, the agency’s director, did just that, overruling her committee, which had defended its vote saying there was insufficient data to recommend boosters for the general population.
Within the FDA, the topic was so contentious that not only did a member of the FDA’s advisory committee publicly campaign against it, but two top FDA vaccine officials—30-year veterans of the agency—resigned over the issue. Those who objected argued that healthy, vaccinated people are already protected against serious illness if they get a breakthrough Covid infection, so a third dose provided little additional advantage.
Then, in November, two strange things happened. First, without convening its advisory committee, the FDA unilaterally approved boosters for all adults. Shortly after, the CDC’s advisory committee did an about-face from its vote two months earlier and approved boosters for everyone starting at age 18, a decision Dr. Walensky immediately endorsed. Continuing on its new path, this January, the CDC’s committee voted to recommend boosters for 12 to 17-year-olds.
What happened? What inspired this total reversal?
In time, perhaps the full story will be told. For now, here’s what we know: the approval of pediatric boosters directly contradicts the guidance of top doctors, like Offit, the two former top FDA officials, and, most damning, the underlying data about safety and efficacy for this younger group.
The most salient concern discussed at several FDA and CDC advisory committee meetings since the summer has been the incidence of myocarditis following vaccination, particularly among young males. Recent data from the Israeli Ministry of Health, the Canadian government, models and trial data from Pfizer, and studies published in various peer reviewed journals—all of which have been almost entirely overlooked by the legacy press—suggest that the CDC has downplayed both the prevalence and severity of this adverse event for this cohort.
Just before the new year, researchers from Kaiser Permanente released a preprint study, which concluded: “the true incidence of myopericarditis is markedly higher than the incidence reported to U.S. advisory committees.” The authors found the equivalent of a 1 in 2,650 chance of myocarditis per second dose for males between the ages of 12 to 17. (This rate was starkly higher than what the CDC had been telling the public: a rate of roughly 1 in 30,000 for 12 to 17-year-old boys and girls. By combining the results for both sexes—girls are at far lower risk—the CDC's findings obscured the real risk to boys.)
These findings from Kaiser echo those from Hong Kong, Ontario, and Israel. By contrast, the Johnson and Johnson vaccine was “paused” on April 13, after just six cases of blood clots. (Subsequent data on J&J associated blood clots showed a rate of 1 in 314,815.)
The CDC, numerous public health authorities, and the mainstream media have resolutely contended that myocarditis in young people is far more common from Covid than it is from the vaccines. Yet a study by researchers at the University of Oxford, published in the journal Nature Medicine in December, shows otherwise. The researchers concluded that 16 to 29-year-olds have the same or potentially higher risk of myocarditis from the second dose of the Pfizer vaccine as from Covid. (A subsequent more detailed analysis by the authors, currently in preprint, estimates males under age 40 could potentially have more than three times the incidence of myocarditis following a third dose of the Pfizer vaccine as they would from Covid.)
That’s not all. Astonishingly, an FDA memo released on December 8, based on Pfizer’s own models, shows that for every 1 million booster doses for 16 and 17-year-olds, 29 to 69 hospitalizations would be averted, but there would also be 23 to 69 cases of myocarditis for the males in that age group. In other words, according to Pfizer, for teenage boys getting a booster is—at best—a wash.
All of these studies speak to the issue of incidence. But there is also the issue of severity.
The CDC has continually referred to vaccine-associated myocarditis as mild. Yet, as the cardiologist Anish Koka noted, “There is no such thing as mild symptomatic myocarditis that puts a young person in the hospital.” Of specific concern are the findings from a study published in December in the journal Circulation. The researchers found that 76% of pediatric patients with vaccine-associated myocarditis had something called “late gadolinium enhancement,” a signal that typically indicates scarring on the heart. Of the patients tested more than a month later, 40% of them still had LGE. Dr. Mark Gorelik, a pediatric immunologist at Columbia University who studies myocardial inflammation, explained that this condition can indicate a risk of developing long-term and potentially serious heart problems. Dr. Gorelik noted that this frightening outcome is not certain for these patients, but rather that the issue demands more study and must be taken seriously.
Most surprisingly, data presented during the CDC’s advisory committee meeting where the members voted to recommend boosters for 12 to 17-year-olds show a negative cost benefit for males in this group. The booster safety data for young people, which comes from Israel, showed what equates to a 10 in 100,000 rate of myocarditis in young males. But, later in that same meeting, another slide showed that vaccinated 12 to 17-year-olds had approximately 0.3 Covid hospitalizations per 100,000 population.
Surely, the CDC presented the second slide in order to show the effectiveness of the vaccine at reducing hospitalizations. But the data it showed also pointedly undermined the committee's eventual recommendation. Here’s why: If you are a vaccinated boy between the ages of 12 and 17, the graph shows the likelihood of being hospitalized with Covid is 0.3 out of 100,000. But if you are a boy in that same group and you get a booster, your likelihood of getting myocarditis is 10 out of 100,000. (Ninety-five percent of diagnosed vaccine-associated myocarditis cases result in hospitalization.)
In other words, if you are a young male who is vaccinated you have two choices. Option A: don’t get a booster and run a 0.3 in 100,000 risk of ending up in the hospital with Covid. Option B: get the booster and run a 10 in 100,000 risk of getting myocarditis.
The risk/reward calculation seemed so crazy that I thought I was misunderstanding it. Did the CDC notice what I was seeing in their slides? I contacted Dr. Sarah Long, a member of the CDC advisory committee and a pediatric infectious diseases specialist at Drexel University. “Your numbers are correct,” she told me in an email. But she said that, in her view, the sample size, with just two incidences of myocarditis out of 20,000 doses to males, was too small to make projections.
According to several epidemiologists who I discussed these data with, extrapolating a 10 in 100,000 incidence of myocarditis from two cases produces what’s known as a “noisy” estimate—meaning the ultimate numbers could be higher or lower. Another factor to consider is that the risk of hospitalization from Covid continues month after month, while the risk of vaccine-associated myocarditis is a one-time potential event. Still, they all said that the central comparison was correct.
The cost benefit is even more problematic when you consider that at least forty percent of pediatric “Covid hospitalizations” are for kids hospitalized “with” Covid, not “because of” Covid. For example, a child who is in the hospital to have foot surgery but who also tests positive upon admission is still counted as a Covid hospitalization.
I spoke extensively with Dr. Long, who provided a very rare window into the CDC’s decision-making process. I wanted clarity on why, based on this very unfavorable cost benefit, she had voted to recommend boosters for boys as young as 12. (Dr. Long spoke for herself, not the CDC or the committee. But it’s worth noting that the committee voted 13 to 1 in favor of boosters. The one dissenting member, Dr. Helen Keipp Talbot, an infectious diseases specialist at Vanderbilt, declined repeated requests for an interview.)
Dr. Long told me this: “We made the decision, in my opinion, without any data on safety.” (What she meant is that she disregarded the Israeli data that showed the two cases of myocarditis in 12 to 15-year-old males because she felt it wasn’t a big enough sample to make an accurate prediction.) Taken aback, I asked her: In the absence of safety data on the children in this age group, why move ahead? She said that data on boosters in the next older age group, 16 to 19-year-olds, suggested to her that myocarditis was not a matter of concern.
But there’s a problem with that assertion: the data from Israel presented in the meeting for 16 to 19-year-old males showed that out of 123,355 booster doses, there was a rate of 6.5 cases per 100,000. This rate still would yield an unfavorable outcome against the fewer than one Covid hospitalization per 100,000 vaccinated 12 to 15-year-olds. According to several experts, the only other booster data for teens is from a Pfizer trial that included just 78 16 and 17-year-olds. And even that small sample yielded a case of myocarditis in a male.
When deciding whether a medical intervention is appropriate safety must be weighed against efficacy. The boosters would need to be so efficacious that giving them would offset an individual’s myocarditis risk. Yet, the FDA memo on Pfizer’s models suggested otherwise. But according to Dr. Long, part of the value of the boosters is that they would provide around two months of additional protection against mild illness until the antibodies wane.
Knowing this–and knowing the risk of myocarditis—Dr. Long voted to approve boosters anyway. Why?
First, because she said the presumed reduction in infections would permit teachers and students to be in school and not have to quarantine—which, given how mild Covid typically is for this age group, seems to be a matter primarily of bureaucratic policy, not health.
Second, because she said we are in an upsurge of Omicron, and she predicted “many more deaths in children.” Yet since Omicron’s arrival, the rough number of pediatric deaths each week has not increased. It’s also not clear how boosters—which of course only apply to kids who are already vaccinated—would greatly reduce their mortality given that they are already protected against severe disease.
Do most American parents understand that part of the rationale behind the booster recommendation was to reduce, by roughly a few months, the chances of getting a mild case of Covid? When I told Dr. Gorelik, the pediatric immunologist at Columbia, what Dr. Long had told me, he was surprised. “I wasn't aware of this line of thinking,” he said. “And I think if this is the goal, it should be made explicit so that there is no confusion about the sought benefit of boosters.”
Dr. Elissa Perkins, an emergency medicine physician at Boston University with an expertise in infectious diseases, told me this: “If a booster is only offering a temporary benefit against minimally symptomatic infection it is really important that this rationale is clear so parents can weigh the trade offs to determine if, in their individual circumstances, the benefits outweigh the risks.”
None of this is to say that the initial doses of the vaccine, and, in some circumstances, boosters, aren’t beneficial for many kids and adolescents—especially for those with underlying health conditions. But the FDA’s approval, and CDC’s recommendations, do not allow for an appropriate degree of agency on the part of parents. This is because recommendations often translate into mandates. And this is especially likely in the case of boosters, since the CDC committee members spent the better part of an hour debating whether to use the word “may” or “should” in their booster recommendation—and voted in favor of “should.”
So it’s not a surprise that universities from Harvard to Hartford have already mandated boosters. It seems almost assured that the new recommendation of boosters for teens will ultimately turn into mandates as well, whether explicit or de facto.
Some restaurants now say diners have to show proof of a booster. The CDC changed the language of its guidance recently, saying everyone starting at age 12 should stay “up to date,” which it defines as being boosted. Being “up to date” on vaccines, of course, is the default requirement for many child-centric organizations. Some summer camps have already sent letters to parents notifying them that campers must be fully vaccinated, which is likely to come to mean boosted.
Recently, students at universities across the country have looked at the data themselves. And they have raised serious concerns about what they are being forced to do. Petitions to repeal booster mandates at Stanford, Cornell, George Mason, UMass, Arizona State, Boston College, and Yeshiva attest to this. Their pleas are not rooted in ignorance and obstinance, as even the most minor opposition to any number of pandemic policies has so often been portrayed, but are impassioned and educated. They’re not asking for much, just for our institutions to catch up with the knowledge that regular citizens already have.
Throughout the pandemic, American public health guidance for kids—on school closures, masking, and now vaccine policy—has been far more maximalist than that of many other countries. Restraint and subtlety, perhaps at times for good reason, are not the American way. But one thing is certain: When public health policy is wielded as a blunt instrument, people do not want to get hit.
