When Dr. Debra Langlois learned in February 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.”
Now, Moderna has announced that it has submitted a request for emergency use authorization of its coronavirus vaccine for children 6 months through 5 years old. But it remains unclear when federal health officials may give a pediatric vaccine the green light. In an interview with CNN+ last Thursday, Dr. Anthony Fauci indicated that the Food and Drug Administration may wait to authorize vaccines for young children until data from both Pfizer and Moderna is available for review, which may not happen until June.
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.
As pandemic precautions like mask mandates are dropped and social distancing is abandoned in favor of the return to normalcy, the F.D.A.’s delay in authorizing shots for infants and toddlers, has 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
In the beginning of the February, 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. Pfizer is expected to have these results by May.
This pivot was especially perplexing because the F.D.A. had pressed Pfizer 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 has 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.
By starting the approval process for two doses of the Pfizer vaccine, the F.D.A. might have been able to certify at least those doses sooner rather than later, said Dr. Sallie Permar, chair of pediatrics at Weill Cornell Medicine. Then regulators could have added a third dose once trial data was available. Now the agency will likely review all three doses together in June.
Moderna has been testing a two-dose regimen for children under 6 that contains a slightly higher concentration of vaccine per dose compared to Pfizer’s shots. In a statement on Thursday, Moderna said that their vaccine was 51 percent effective in preventing Covid among children 6 months to 2 years old and 37 percent effective in children 2 to just under 6. The efficacy in infants is only slightly higher than preliminary results announced by the company in March, though Moderna said that the efficacy estimates “are similar to vaccine efficacy estimates in adults against Omicron after two doses.”
Moderna is also planning to evaluate booster doses of the vaccine, as well as a so-called bivalent booster, which will combine the existing vaccine with targeted protection against the Omicron variant for all pediatric groups. The company requested emergency authorization for a vaccine for children 6 to 11, as well as updated one for those 12 to 17 last month. (Currently, Pfizer’s vaccine is the only one authorized for children as young as 5.)
What this means for families
It is important that regulators take their time in ensuring that the vaccine adequately protects young children without compromising safety and effectiveness.
April 28, 2022, 7:55 p.m. ET
“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.
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, less than 30 percent of 5-to-11-year-olds and less than 60 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.”