Covid Vaccines for Kids Under 5: What Parents Should Know

When Dr. Debra Langlois learned last week that federal regulators had delayed the review of Pfizer-BioNTech’s coronavirus vaccine for children under 5, her reaction was just as visceral as any parent’s. “I was like, ‘Are you kidding me?’ Every day my daughter can’t be vaccinated, she’s at risk.”

Keeping young children safe has been an exhausting exercise for parents throughout the coronavirus pandemic. And many parents are eager to get their littlest ones vaccinated, said Dr. Langlois, who is a pediatrician at the University of Michigan Health C.S. Mott Children’s Hospital and who has two young children, one of whom is under 5.

When the Food and Drug Administration seemed close to authorizing two shots for infants and toddlers, their last minute waffling only added to parents’ mental fatigue. Here’s how to make sense of what happened and what it may mean for your family.

What is going on

At the beginning of the month, the F.D.A. announced that a panel of independent health experts would convene on Feb. 15 to determine if two doses of Pfizer-BioNTech’s Covid-19 vaccine would be safe and effective for children ages 6 months through 4 years old. But in a highly unusual move, the agency called off this meeting just days before it was scheduled to occur, explaining that it would now wait to evaluate data from three doses instead of two, which isn’t expected until April at the earliest.

This pivot was especially perplexing because the F.D.A. had pressed Pfizer-BioNTech to initiate the review of two doses of the vaccine, despite disappointing clinical trial results from December, which found that two doses did not adequately protect children between 2 and 4 (though they did seem to protect those between 6 months and 2 years old). Pfizer and BioNTech have been saying since December that children under 5 would probably need three vaccine doses, each of which would be just one-tenth of the dose that those 12 and older receive.

F.D.A. regulators may have been hoping that by starting the approval process for two doses before the three-dose trial data was available, they could start vaccinating young children sooner rather than later, said Dr. Sallie Permar, chair of pediatrics at Weill Cornell Medicine. And, if new data collected since December showed that the vaccine had protected children against symptomatic or severe illness through the Omicron surge, that may have given regulators more information to work from in their review of the vaccine for children under 5.

But, Dr. Permar said: “It seems from the announcement on Friday that maybe that data wasn’t quite as rosy as they had hoped.”

What this means for families

As disappointing as the delay is, it is important that regulators take their time in ensuring that the vaccine adequately protects young children without compromising safety and effectiveness.

“I have tremendous sympathy for parents because this is a very stressful time,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital and a member of the F.D.A.’s vaccine advisory panel. But it’s also important “to have sympathy with the people at F.D.A. They’re in a tough spot. They’re simultaneously being criticized for moving too fast and too slow.”

“You can’t rush safety,” said Dr. Yvonne Maldonado, a pediatric infectious diseases physician who is overseeing the Pfizer-BioNTech trial at Stanford University. Sometimes one dose — or even two doses — is not enough to boost immunity, she said. “It’s not that the first dose doesn’t work, it’s just that you may need more than one or two doses to make sure you get higher levels of protection. And so testing that takes time.”

It’s actually pretty common for young children to need multiple doses of a vaccine to get a big enough benefit, Dr. Maldonado said. The hepatitis B vaccine is given to children as three doses, while the diphtheria, tetanus and pertussis (DTaP) vaccine typically requires five doses.

Some parents have wondered: If a two-dose regimen worked well for kids between 6 months and 2 years of age, why couldn’t the F.D.A. approve the vaccine just for that age group? Unfortunately, “it doesn’t work like that,” Dr. Levy said. “You can’t look at the results after the fact and say, ‘Oh, you know what? We change our mind about how we’re analyzing this. We’re just going to separate out a group, and you only need to approve things for this subgroup.’”

For similar reasons, parents can’t go to their child’s pediatrician to request a lower dose of the vaccine before it’s approved, Dr. Levy said. Vaccine doses are carefully reviewed and approved based on the risks and benefits to each age group.

The good news is that once the vaccine for kids under 5 is approved, the rollout should be much faster than it was for adults, Dr. Permar said, since pediatricians’ offices are already set up to receive and administer vaccinations. “I think we’re looking at late spring at this point,” she said.

And there’s still a lot you can do now to protect your family and prepare. If your child is afraid of needles, start getting them ready by teaching them relaxation techniques or reading them relevant books. If you’re concerned about how the Covid-19 vaccine will fit into your child’s regular shot schedule, or if you have questions about potential side effects, discuss it with your pediatrician, Dr. Langlois said.

And continue to follow public health measures like social distancing and masking where possible, as well as getting your older children vaccinated. According to data from the Centers for Disease Control and Prevention, only 24 percent of 5-to-11-year-olds and 57 percent of 12-to-17-year-olds have been fully vaccinated.

The coronavirus is still causing illness in young children and disrupting their lives, Dr. Langlois said, but parents should not give up hope. “We’re going to get there,” she said. “Parents, including myself, just need to be a little more patient.”