The White House on Thursday rolled out a host of new policies aimed at getting more Americans vaccinated for COVID. The new rules—including vaccination mandates for federal workers and contractors, health-care facilities that receive federal support, and businesses with 100 or more employees—could help to nudge the roughly 80 million Americans over the age of 12 who haven’t gotten jabbed.
But the policies don’t apply to the nearly 50 million Americans under 12 years old. The U.S. Food and Drug Administration might still be months away from approving a COVID vaccine for under-12s. And as long as these kids can’t get vaccinated, the country could struggle to reach population-level “herd immunity.”
Generally speaking, COVID is less dangerous to children than adults. The older you are, the greater your chances of developing a serious infection that could result in hospitalization—or, worse, death. But that doesn’t mean under-12s don’t transmit the disease.
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All those unvaccinated kids can’t help but keep the pandemic going. “One of reasons why infections never completely go away is because children are a non-immune cohort,” Jeffrey Klausner, a former professor of medicine and public health at UCLA, told The Daily Beast.
There are good reasons for the delay in greenlighting vax for kids, however. “Children are not little adults,” Mary Jo Trepka, a Florida International University epidemiologist, told The Daily Beast. “They are physiologically different from adults and from adolescents.”
Vaccine-makers need more data in order to be confident in the jabs’ safety for under-12s. “It's not just that the immune systems function differently in kids,” Irwin Redlener, the founding director of Columbia University’s National Center for Disaster Preparedness, told The Daily Beast. “We also don't know what proper doses of vaccine are at different ages and weights for kids. I appreciate the caution in making sure the process is done correctly.”
Shortcuts are unacceptable to the key decision-makers. Burned by the painful testing of the polio vaccine 70 years ago, government and industry are reluctant to take chances with kids’ health.
The consensus is that vax trials for under-12s should proceed slowly, in gradually expanding phases with incrementally increasing doses of vaccine, only after jabs are proving safe in the older population. Even if that means allowing a nearly two-year pandemic to rage even longer.
“You’re going slower because you want to be sure of safety, safety, safety,” Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told The Daily Beast.
The pharmaceutical industry moved with unusual speed to develop COVID vaccines and enroll tens of thousands of teens and adults in large-scale trials. Pfizer and Moderna submitted initial trial data to the FDA last fall. A few weeks later, the feds gave both companies—and, later, Johnson & Johnson—emergency authorization to begin jabbing older teens and adults. Sixteen and older for Pfizer, 18 and older for Moderna and Johnson & Johnson.
After getting a few months of additional safety data, the FDA in May expanded Pfizer’s emergency-use authorization to include kids as young as 12. At that point, a full 80 percent of the U.S. population of around 333 million was eligible to get jabbed by one vaccine or another.
And then the country began waiting for younger kids to get approved. New York-based Pfizer and Moderna in New Jersey began testing their two-dose messenger-RNA vaccines on thousands of under-12s back in March. Six months later, both companies are still collecting safety data—in essence, waiting to see if the young volunteers develop any dangerous side effects.
Pfizer is expected to submit data first. After all, the FDA has already cleared that company’s vaccine for kids ages 12 to 17, whereas the feds are still weighing Moderna’s request to vax that age group.
“We anticipate a potential pivotal readout for children between the ages of 5 and 11 this month and, pending the data demonstrating safety and immunogenicity and in agreement with regulators, we could potentially submit for a U.S. emergency use authorization shortly after that,” Kit Longley, a Pfizer spokesperson, told The Daily Beast.
“Data for kids 2 and under 5 could arrive soon after that,” Longley added. “For children between 6 months and 2 years, we could potentially have a safety and immunogenicity readout … sometime in October/November, followed by a potential submission to the U.S. FDA for an EUA once agreed upon with regulators shortly thereafter.”
After getting the data, the FDA will decide whether to authorize the vaccine for under-12s. “The agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” acting FDA Commissioner Janet Woodcock and Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, said in a joint statement. “However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers.”
The White House on Thursday promised to support a swift approval. “The administration will do whatever it takes to support those efforts, while continuing to respect and defer to the scientific decision-making of the agency.”
Industry developers, outside experts and federal regulators are especially worried about myocarditis, a potentially dangerous inflammation of the heart. Myocarditis is a possible, albeit very rare, side effect of Pfizer and Moderna’s mRNA vaccines.
As of June, around 1,200 Americans have shown symptoms of myocarditis and a similar heart condition apparently resulting from vaccination. According to the U.S. Centers for Disease and Control, inflammation occurs most frequently in male adolescents and young adults—usually a few days after receiving their second dose. It seems the younger you are, the more vulnerable you are to myocarditis.
The CDC didn’t immediately respond to a request for comment.
Pfizer is closely watching its under-12 trial subjects for signs of myocarditis. The frequency and severity of cardiac inflammation surely will be the key point when the firm finally submits its data to the FDA.
No one expects the feds to approve the vax for younger kids in time to save the school year. Mass outbreaks of COVID among unvaccinated students are already tragically widespread across the United States, provoking fierce debates over school mask mandates and compelling some of the worst-hit schools to return to internet-based remote instruction.
But it’s not worth risking the health of millions of kids in order to salvage in-class education. Older experts remember the last time that industry rushed vaccine trials for children. In the early 1950s, the National Foundation for Infantile Paralysis— a.k.a, the March of Dimes—seized on a new polio vaccine developed by a scientist named Jonas Salk and, without a lot of safety guardrails, worked with state health agencies to quickly enroll more than 600,000 kids in a large-scale trial.
The vaccine ultimately proved safe and effective. But the trial itself was enormously risky. The testers gave 200,000 of the test subjects a placebo—now widely considered an unnecessary move—before sending them back into the world to face exposure to polio, a disease that causes paralysis.
Sixteen kids died from polio. Thirty-four ended up paralyzed. “The history of drug regulation is built on tombstones,” Offit said, echoing a medical truism attributed to Smithsonian historian Michael Harris. No one wants those tombstones to bear the names of children.
Drug-developers and regulators have gotten a lot more cautious in the decades since the polio-vax debacle. Even a surge in under-12 infections, which experts attribute in part to the more-infectious Delta variant of SARS-CoV-2, hasn’t motivated industry and the feds to accelerate the process.
At the current rate of new vaccinations, more than 80 percent of Americans over 12 could be at least partially-vaccinated before any under-12s who aren’t part of the trial group get their first jab. For a while, kids younger than 12 could continue representing a serious COVID transmission risk—the last big cohort of unvaccinated Americans.
It’s a risk even Pfizer acknowledges. “Children under the age of 15 account for 26 percent of the global population,” the company explains on its website. “We believe successfully vaccinating children will contribute to protection against COVID-19 if the vaccine proves to be effective in that population.”
But as far as the pharmas and the feds are concerned, the risk that under-12s might prolong the pandemic is more acceptable than the dangers of hurried trials—to say nothing of the prospect of widespread, serious side effects in children from an inadequately tested vaccine. “It’s not a risk-free choice, it’s a choice to take a different risk,” Offit said.
When it comes to kids, better safe than sorry. Even in a pandemic.
