What’s Holding Up the COVID Vaccines for Children Under 5?

But opaque communication from the U.S. Food and Drug Administration and drugmakers, on top of whiplash over the shifting timeline and unexpected delays, has led to confusion and angst. Some parents are obsessively tracking every press release, investor report and social media announcement to glean information, and a few have even lied about their kids’ ages to get their children vaccinated. Many feel they are on their own.

“I just feel like we are being left on Pandemic Island,” said Jen Wendeln, mother to a 3-year-old boy in Cincinnati. “They’ve sent rescue boats several times and then told us: ‘Never mind, none for your children. Don’t worry, we’ll come back, just keep waiting.’”

Parents have been told that vaccines for little ones are coming “soon” over and over. In September, Pfizer’s CEO Albert Bourla said that two-shot data for 2- to 4-year-olds would be available “before the end of the year,” with submission to the FDA soon after. That data turned out to contain mixed news, and timelines got pushed out as Pfizer added a third shot. Parents grew hopeful when Dr. Anthony Fauci suggested authorization could happen sometime in February, and momentum seemed to be gathering as the FDA scheduled a meeting of outside experts to review Pfizer’s data on Feb. 15 to consider authorizing two doses first while waiting for data on the third. In the latest twist, however, the FDA then delayed that meeting, saying that new information had led it to decide it was better to wait for more data.

All of this happened as first the delta variant, then omicron, sent an increasing number of children to the hospital, filling up pediatric wards. Some parents, hearing experts urge the public to get vaccinated as soon as possible to prevent catching the highly infectious variant, were frustrated not to have that option for their children. “I put my kids in car seats. I laid them on their back when they were babies so they wouldn’t suffocate,” said Dr. Amy Cho, an emergency room physician in Minnetonka, Minnesota. Knowing that vaccines are preventing deaths in kids over 5, it pains her that one isn’t available yet for her 3-year-old. “I couldn’t live with myself knowing I didn’t do everything I could to prevent that outcome,” she said.

Thousands of parents have turned to Facebook groups to share information and seek answers to their questions: Why the delay? When would the data become public? What is going on with the trials? Conspiracy theories have blossomed and rumors are rampant.

To bring some clarity to the conversation, I dug into FDA policy and asked officials at the agency, Moderna and Pfizer as well as pediatric vaccine experts the questions parents most want answered. What I learned dispels a widespread myth, adds context to the factors officials are deliberating and provides an update on timing.

Why Do Parents Want a Vaccine?

While children under 5 are much less vulnerable to the coronavirus than adults, they are not invulnerable to serious consequences. In the United States, more than 460 children under 5 have died of COVID-19, according to the CDC. They’ve been hospitalized and have died at a higher rate than kids ages 5 to 11, according to the agency. “It’s very frustrating for us, writing off kids who have died — what’s the acceptable number of child deaths for people?” asked Dr. Scott Krugman, vice chair of pediatrics at the Herman & Walter Samuelson Children’s Hospital at Sinai. “If it’s preventable, it should be zero.”

A source of anxiety for many parents is that it’s hard to predict which kids may have bad outcomes. While children with asthma or other lung conditions are more likely to suffer from pneumonia if they are infected, researchers still don’t know what puts a child at higher risk of suffering from multisystem inflammatory syndrome, or MIS-C. The condition, in which many different organs including the heart, lungs, kidneys and brains become inflamed, can be serious and even deadly. Children with no preexisting conditions are often the ones who experience MIS-C, Krugman said: “They’re perfectly healthy 4- or 5 year-olds who randomly show up with cardiac enzymes through the roof and who need close monitoring and support.” Some other children also experience symptoms that last for months.

Experts have been telling parents that they can keep their little ones safe by surrounding them with people who are vaccinated, boosted and masked. But many parents point out that restrictions are easing and people are becoming more active, so the risk is actually increasing for their children. As schools drop mask mandates as well, some parents are also worried that their vaccinated older kids could bring the virus home to their unvaccinated younger siblings.

“Things are getting less safe for those of us who cannot vaccinate our family members — knowing there are even fewer people wearing masks makes everything that much more dangerous for us,” said Chris Nammour, father of a 2-year-old in Puyallup, Washington. So far, he’s chosen not to send his daughter to day care. “Our world is very small.”

What Exactly Does the FDA Consider Before Approving the Vaccine?

Many parents who want a vaccine say they don’t expect perfection: They don’t expect it to prevent infection, but want to lower the risk of the worst outcomes for their children, like hospitalizations or Long COVID. Emily Whittington is one of them. Her 4-year-old son, Jeremy, was born with a rare gene mutation that causes brain malformations and is particularly at risk of experiencing a seizure if he gets sick. Whittington lives in rural West Virginia and said that the low vaccination rate in her area has made her have to keep Jeremy out of pre-K to avoid exposure. “Can any of those doctors or advisory boards look me in the eye and say, ‘Your son is better off getting COVID without the vaccine than with some protection?’”

But the agency isn’t considering Whittington’s situation in isolation; it has a far more complicated calculus to make. “In addition to those people who are really excited about getting their kids vaccinated, there are also a lot of people out there that are like … I really want to know that, if the FDA tells me I’m going to have to give this to my kid or I should give this to my kid, I want to know that it really works,” an FDA official, who spoke on the condition of anonymity, told me. Only 1 in 4 children ages 5 to11 was fully vaccinated as of March 1, and polling has shown that about a third of parents want to “wait and see,” while another third do not plan to get their child the shot.

“The challenge we have is, if we take something forward where there’s tremendous controversy because the data are not really clear, there can be a lot of confusion in the public, and ultimately, it can be counterproductive for getting the population vaccinated,” the official said.

The FDA also considers what’s going on in real time. When cases of omicron were surging and more and more kids were being hospitalized, the agency made an unprecedented move by saying it would consider authorizing two shots of the Pfizer vaccine for kids under 5 while waiting for the rest of the efficacy data on a third shot. The thinking was that those kids could get a head start on the vaccine series before the third shot was authorized. But the plan also hung on the presumption that the third dose would do the trick. What if Pfizer’s three doses still weren’t enough? Some experts worried that it was a risky move for the agency to take.

“If it didn’t work out, the price they could pay could be a lack of confidence not just in the COVID-19 vaccinations but a spillover into other childhood vaccinations,” said Dr. Peter Hotez, a pediatrician and dean for the National School of Tropical Medicine at Baylor College of Medicine. And what if a fourth or a fifth dose was ultimately needed? asked Dr. C. Buddy Creech, professor of pediatrics and director of the Vanderbilt Vaccine Research Program. “Do side-effect profiles go up when we do that? Does it change over time if you keep hammering the immune system with the same antigen over and over again?”

Pfizer, which was gathering data in real time, reportedly found that its shots were less effective against the omicron variant. With this new information in hand, the FDA decided to delay and wait for data from all three shots to come in before considering authorization. One factor in the decision was that risk for children overall has dropped as omicron cases have fallen. “In the midst of a huge surge, the benefit/risk [calculation] could be different than when you’re now coming towards the tail of a surge,” the FDA official said. “It doesn’t change our essential considerations, which are that the vaccine has to show the safety that we need … but it is true that the efficacy that we would expect, that could be a little bit different depending on the amount of disease that was circulating at a given time, the amount of hospitalizations, etc.”

The agency has a challenging job of balancing the need for thoroughness with speed, said Dr. Paul Spearman, director of the division of infectious diseases at Cincinnati Children’s Hospital Medical Center. Children are not just little adults — their immune systems are different — so you can’t just scale down the existing vaccine proportionally and presume it’ll be both safe and effective. It’s not unusual for children’s vaccine trials to take longer than adults’ because of additional steps needed to find the correct dosage for different age groups, Spearman said. “There’s more care taken about safety and finding a precise dose, and more scrutiny, because it’s a vulnerable population.”

Ian Stone, parent of a 4-year-old in San Diego, said he’s willing to wait for a vaccine. “I want it to be safe. I want it to be effective. I don’t want it to be pushed forward because we have to have something,” he said. But Stone, who works in public relations, said he thinks the unexpected delay “may cause more harm than good. It’ll make people question and scrutinize it that much more. If it wasn’t ready, I wish they hadn’t gotten hopes up because you’ve drawn unwanted attention.”

Is “Age De-escalation” a Real FDA Vaccine Policy?

Misinformation has further confused parents, causing unnecessary concern that vaccines will be further delayed.

In December, Pfizer said that two shots were found to be safe for all kids under 5, but while children under 2 generated antibody levels similar to what has been seen in 16- to 25-year-olds, the 2- to 4-year-olds did not hit the same bar for effectiveness. In response to the results, the drugmaker said it would start testing a three-shot regimen to see if that could increase the level of protection.

For parents of children under 2, the obvious question was: Why not authorize the shot for the babies first?

It was surprisingly hard to get a clear answer to this question. A myth sprung up and circulated around the internet, printed in traditional media and repeated by doctors, that the FDA had a policy that prohibited it from authorizing vaccines for age groups out of order. It was referred to as an “age de-escalation policy.”

Age de-escalation describes how some clinical trials are run, including the COVID-19 vaccine trials. Adults are enrolled first, and once the vaccines are proven safe and effective, then the trial extends to younger and younger age groups. This is important for a number of reasons including safety — adults and teens are better able to articulate side effects they may be experiencing, so if a side effect is identified as related to the vaccine, researchers can look out for that symptom in younger kids who may not be as articulate; a fussing baby, as every parent knows, can be difficult to interpret.

But when it comes to authorizing vaccines, that doesn’t apply. “There’s no such policy, and we would have been happy to skip an age group,” the FDA official told me.

I also asked Pfizer why, then, it hadn’t sought authorization for kids under 2 first. The oblique answer I got from a spokeswoman was: “We’re continuing to study a third dose in this population.” I asked for more information and was told, “If successful, we will pursue a three-dose series based on the ongoing late stage study.”

So Pfizer is pursuing a three-dose series for all kids under 5. But why do that, if two doses had worked for the younger age group?

The FDA is tightlylimited by regulation and cannot publicly discuss trial data before approval outside of specific circumstances, such as an advisory committee. That has accounted for much of the agency’s reticence. The official could only tell me, enigmatically, that “eventually it will become clear that there was not a way to skip an age group here.” Perhaps something in Pfizer’s data in infants made the drugmaker or FDA determine it wasn’t sufficient for authorization, but until data becomes public, it is impossible to know.

As for Moderna, authorization of its vaccine for 12- to 17-year-olds has been held up in the U.S. because of concerns that it could cause myocarditis, inflammation of the heart muscle. Moderna is now testing a smaller dose for adolescents and 6- to 11-year-olds, but in the meantime, the company has said that it expects data from its trial of kids under 5 in March.

Parents, again confused by the supposed age de-escalation policy, have speculated that Moderna could not ask the FDA for authorization for the youngest kids before the teens had access to the vaccine.

Not so, a Moderna spokesperson told me: “Once the data are available in this age group, Moderna will review the data and decide whether to file for Emergency Use Authorization independent of whether other EUA submissions currently under review have already been approved.”

What’s Next for Vaccines for Small Children?

Here’s the good news: Two companies could have data on vaccines in kids under 5 in a matter of weeks. Pfizer has said it’ll have data on three doses “in spring” and Moderna has said it’ll have data by the end of March. If the data looks good, there’s nothing to stop the FDA from authorizing a vaccine for kids of a certain age group, even if an older cohort misses the mark or hasn’t yet gotten the green light. Creech, who is also a principal investigator for Moderna’s pediatric vaccine trials, and Spearman both told me they expect authorization by April or, in a worst-case scenario, May.

The bad news is that this far into the pandemic, communication is still floundering in the face of a public that is increasingly distrustful of scientists and federal health agencies.

It’s true that the FDA is legally limited in discussing data particulars and manufacturers are traditionally secretive about ongoing trials. But nobody has acknowledged that the legal and conventional restrictions mean that answers to basic questions like, “Why was this review delayed?” tend to result in impenetrable answers like, “We realize now in data that came in very rapidly because of the large number of cases of omicron that at this time it makes sense for us to wait until we have the data from the evaluation of a third dose.” None of this helps the public understand the scientific process.

What is apparent is that while many parents would like to see more data, what they want even more is to be reassured that their kids’ health is a priority.

“They’ve never spoken to parents of underage kids to say: ‘We’re sorry this is so hard. It grieves us too that it’s been so complicated,’” said Jennifer Martin, a parent of three in Seattle. “There’s a lack of urgency,” said Samirah Swaleh, parent to a 9-month-old boy in the Los Angeles area. “They just don’t seem to care about babies and toddlers?!” wrote Wendeln, the mother in Cincinnati. Cho, the emergency room physician, longs for a clearer timeline. “If you’re running a marathon and you know there’s an end, people can do amazing things. But it’s really, really hard when you don’t know if there’s an end in sight.”

I brought these sentiments to the FDA official I spoke to. The response hit many of the notes the parents said they wanted. I wish it could have come earlier, more often and been on the record, but I hope it provides some parents a bit of reassurance that they’ve been heard.

“We are going to work as expeditiously as possible,” the official said. “What does that mean? In general — though I can’t promise anything — you’ve seen that after an EUA [application] in this area, we generally are trying to take action in two to four weeks.”

The official emphasized: “We’re not going to be sitting on anything here.”

“I would want parents to know that we understand their concerns. We’re parents too,” the official added. “We are going to move as fast as we can once we have the data in our hands.”