New York pharma Pfizer has asked the U.S. Food and Drug Administration to give emergency-use authorization to the company’s messenger-RNA COVID-19 vaccine for U.S. residents from 6 months to 5 years old. All 24 million of them.
Experts say approval could come in a matter of weeks, and once the FDA gives Pfizer the nod to offer two doses of mRNA to under-5s, almost all Americans will be eligible for jabs.
Whether there’ll be a massive uptick in vaccinations, however, is still up in the air. Many American parents have made it pretty clear in recent months that they’re in no hurry to get their kids vaccinated, despite the clear benefits of doing so—and the equally clear risks to not doing so.
But that doesn’t mean emergency-use authorization for under-5s is pointless. Health agencies all over the world look to the FDA to lead the way when it comes to authorizing vaccines. There’s a good chance that, once the U.S. approves vaccines for young children, a lot of other countries are going to do the same. “It’s a big deal,” Irwin Redlener, the founding director of Columbia University’s National Center for Disaster Preparedness, told The Daily Beast.
The challenge now will be getting enough doses in the right places to quickly immunize millions of kids. More than a year after the first COVID vaccines became available, some poorer countries still don’t have enough jabs for adults.
“Lower-income countries often have very high numbers of young children, and there would be pressure to vaccinate them, as well,” Lawrence Gostin, a Georgetown University global-health expert, told The Daily Beast. Expanding eligibility only underscores the vaccine shortfall.
The FDA has steadily expanded the vax-eligible population since initially giving emergency-use authorization to Pfizer and fellow mRNA-maker Moderna in late 2020. There’s a good reason under-5s are last.
Not only do children’s immune systems work differently than adults’ do, we as a society tend to be more protective of kids. “You want to get as much info as you possibly can before putting it out there,” Jeffrey Klausner, a professor of medicine and public health at UCLA, told The Daily Beast last year as the FDA was weighing jabs for children under 12. “The number-one issue is safety.”
It took a year for Pfizer and its German partner BioNTech to watch 8,300 under-5 trial subjects, analyze the data and settle on a dosage—two 3-microgram shots, three weeks apart—that the company is confident is both safe and effective. “If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children,” BioNTech CEO Ugur Sahin said in a statement.
Pfizer and BioNTech are already studying a third dose—a booster—for under-5s and plan to ask for FDA approval in coming months. Moderna, for its part, announced it would ask for emergency-use authorization for its own jabs for young children as early as next month.
Responding to an inquiry from The Daily Beast about how long it could take to approve the Pfizer jab to children under 5, an FDA spokesperson told The Daily Beast that “While we cannot predict how long the process may take,” the FDA’s evaluation “is being conducted as expeditiously as possible,” adding that the process is “intended to ensure that the known and potential benefits of the vaccine outweigh its known and potential risks when used in this population.”
“We’re kind of stalled on 5-to-11-year-olds even, though they’ve been eligible for months now.”
It’s unclear exactly how effective Pfizer’s mRNA is in under-5s. The company didn’t immediately respond to an inquiry. But the U.S. Centers for Disease Control and Prevention stressed that, in older children aged 5 to 11, the Pfizer jab is “over 90 percent” effective at preventing COVID.
Severe COVID isn’t actually a major risk in younger kids. For reasons virologists and immunologists don’t yet fully understand, the SARS-CoV-2 virus tends to spare children the worst outcomes.
It’s for that reason that Klausner, for one, said the FDA should worry less about 28 million unvaccinated under-5s and more about the roughly 6 million Americans over 65 who aren’t yet fully vaccinated and are highly vulnerable to COVID. “Focusing on a very-low-risk group like under-5-year-olds does not make good public health sense in the COVID pandemic which has highly asymmetric risk based on age,” Klausner said.
Mary Jo Trepka, a Florida International University epidemiologist, stressed that it’s important to vaccinate under-5s—but not as important as getting more older Americans boosted with a third dose of mRNA.
“They can definitely transmit COVID-19 to others.”
Multiple studies have affirmed that a third shot reverses the gradual decline in the vaccines’ effectiveness and helps protect against dangerous new variants of the SARS-CoV-2 pathogen. But just 42 percent of Americans have gotten that additional shot. “The percentage of people in the U.S. who are boosted, that is up to date on their COVID vaccines, is way too low,” Trepka said.
No serious expert denies the importance of protecting older Americans and pushing booster shots. But some reject the idea that under-5s should be a low priority. They point out that younger kids can spread the disease without getting sick themselves—and might even spread it to older and more vulnerable relatives.
Schools packed with unvaccinated kids—in particular, schools with poor ventilation and optional masking—can be significant disease vectors. The kids might not get sick. But “they can definitely transmit COVID-19 to others,” Cindy Prins, a University of Florida epidemiologist, told The Daily Beast.
Vaccinating the millions of under-5s who attend preschool and kindergarten could do a lot to slow the spread. “We’re talking about a significant public-health rationale” for vaccinating young kids, Redlener said. Imagine “living with grandma who is 87 and who has multiple preexisting conditions,” he added. “That person would be at pretty high risk.”
But even with grandma’s health at stake, Americans aren’t likely to rush to the pharmacy to get their kindergartners jabbed. “We’re kind of stalled on 5-to-11-year-olds even though they’ve been eligible for months now,” Redlener pointed out. Just 20 percent of that age group is fully vaccinated, compared to around 64 percent for Americans as a whole.
There are good reasons to believe other countries might do better. Only a few countries—Russia, for one—contend with the same degree of vaccine-hesitancy as the U.S. And while a vocal anti-vax minority has made large-scale vaccine mandates politically treacherous in the U.S., many other countries can mandate jabs without triggering an electoral meltdown. Just look at Austria, which in late January made COVID vaccination compulsory for most residents.
Americans might hesitate to get their under-5s vaccinated, potentially prolonging the pandemic even further in the U.S. But if health agencies in other countries follow the FDA’s lead and authorize shots for under-5s, there could be a global uptick in vaccination with widespread benefits for billions of people.
In an unfortunate twist, however, the countries that would benefit the most from vaccinating under-5s—those with larger young populations—are also among the least likely to have enough doses on hand for their younger residents.
African countries—especially in the central part of the continent–tend to be younger overall. But they’re also poorer, overall. And that poverty has landed them last in line for supplies of the best vaccines.
Consider the Republic of Congo, the Democratic Republic of Congo, Uganda and Burundi—all in Central Africa. All have vaccination rates in the single digits. They also have very young populations, with nearly half their residents under the age of 15. That’s double the percentage of under-15s in the U.S.
There’s a good chance that, in the coming months, almost everyone in the world will be eligible for a COVID vaccine. But in order for this expanding eligibility to pay off, richer countries and key world bodies—including the World Health Organization and the global vaccine-distributor COVAX—must work harder, Gostin said. “This all poses a challenge for WHO and COVAX in ensuring ample supplies of vaccines and distributing them fairly.”