When Dr. Debra Langlois learned last week that federal regulators had delayed reviewing Pfizer-BioNTech’s coronavirus vaccine for children under 5, her reaction was just as visceral as that of anyone. what parent. “I was like, ‘Are you kidding me?’ Every day my daughter cannot be vaccinated, she is at risk.
Keeping young children safe has been a grueling exercise for parents throughout the coronavirus pandemic. And many parents are eager to get their little ones vaccinated, said Dr. Langlois, a pediatrician at the University of Michigan’s CS Mott Children’s Hospital and who has two young children, one of whom is under 5. .
When the Food and Drug Administration looked set to authorize two shots for infants and toddlers, their last-minute dithering only added to parents’ mental fatigue. Here’s how to make sense of what happened and what it may mean for your family.
What’s going on
Earlier this month, the FDA announced that a panel of independent health experts would meet on February 15 to determine whether two doses of Pfizer-BioNTech’s Covid-19 vaccine would be safe and effective for children aged 6 months. at 4 years old. . But in a highly unusual move, the agency canceled that meeting just days before it was scheduled, explaining that it would now be waiting to assess data from three doses instead of two, which is not planned. before April at the earliest.
This pivot was particularly confusing because the FDA had pressed Pfizer-BioNTech to initiate a review of two doses of the vaccine, despite disappointing results from clinical trials in December, which found that two doses did not adequately protect children between the ages of 2 and 4. 4 years old (although they did seem to protect children between 6 months and 2 years old). Pfizer and BioNTech have been saying since December that children under age 5 would likely need three doses of the vaccine, each of which would be only a tenth of the dose that those 12 and older receive.
FDA regulators may have been hoping that by starting the approval process for two doses before data from the three-dose trial became available, they could start vaccinating young children as soon as possible, a said Dr. Sallie Permar, chairman of pediatrics at Weill Cornell Medicine. And, if new data collected since December showed that the vaccine had protected children against symptomatic or severe illnesses thanks to the Omicron push, it might have given regulators more information to work with in their review of the vaccine for children under 5 years old.
But, Dr Permar said: “It appears from Friday’s announcement that the data may not have been as rosy as they had hoped.”
What this means for families
As disappointing as the delay is, it’s important that regulators take their time to ensure the vaccine adequately protects young children without compromising safety and efficacy.
“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 FDA’s Vaccine Advisory Committee. But it’s also important “to have sympathy for the FDA people. They are in a difficult situation. They are simultaneously criticized for moving too fast and too slow.
“You can’t rush safety,” said Dr. Yvonne Maldonado, a pediatric infectious disease physician who is overseeing the Pfizer-BioNTech trial at Stanford University. Sometimes one dose — or even two doses — isn’t enough to boost immunity, she said. “It’s not that the first dose doesn’t work, it’s just that you might need more than one or two doses to ensure you get higher levels of protection. And so the tests that take time.
It’s actually quite common for young children to need multiple doses of a vaccine to get a large enough benefit, Dr. Maldonado said. The hepatitis B vaccine is given to children in three doses, while the diphtheria, tetanus, and pertussis (DCaP) vaccine usually requires five doses.
Some parents wondered: If a two-dose regimen worked well for children ages 6 months to 2 years, why couldn’t the FDA 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 minds about how we analyze this. We’re just going to split off one group, and you just have to approve things for that subgroup.
For similar reasons, parents cannot visit their child’s pediatrician to request a lower dose of the vaccine before it is approved, Dr. Levy said. Vaccine doses are carefully reviewed and approved based on the risks and benefits for each age group.
The good news is that once the vaccine for children under 5 is approved, rollout should be much faster than for adults, Dr. Permar said, because pediatricians’ offices are already set up to receive and administer vaccines. “I think we’re looking at late spring at this point,” she said.
And you can still do a lot now to protect your family and prepare yourself. If your child is afraid of needles, start preparing him by teaching him relaxation techniques or reading relevant books. If you’re worried about how the Covid-19 vaccine will fit into your child’s regular immunization schedule, or have questions about potential side effects, talk to your pediatrician, Dr. Langlois said. .
And continue to follow public health measures like social distancing and masking where possible, as well as vaccinating your older children. According to data from the Centers for Disease Control and Prevention, only 24% of 5-11 year olds and 57% of 12-17 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 lose hope. “We’ll get there,” she said. “Parents, myself included, just need to be a little more patient.”