Delay in COVID-19 vaccines for kids upset parents. Experts say it was the right thing to do.
Many parents were disappointed when the Food and Drug Administration decided this month to postpone consideration of COVID-19 vaccines for kids under 5.
Experts said the decision was the right one. The FDA won't have enough data until the spring to judge whether a vaccine is safe and effective for young children, a half-dozen public health, infectious disease specialists and epidemiologists told Paste BN.
Parent activists said the move made them question the agency's sincerity in providing shots for the youngest kids, wonder whether unreleased data was hiding anything and yearn even more for the day they can stop worrying about the health of their children and families.
"I think people are really forgetting the kids here," said Fatima Khan, co-founder of Protect Their Future, an advocacy group promoting COVID-19 vaccination for children. "This is impacting our kids and how people can live their daily lives."
Vaccines and medications are typically tested on adults first, then older children and when it's clearly safe, on younger ones, which is why there has been such a lag since adult vaccinations began.
During the pandemic, Khan said, there should have been more urgency, perhaps trials running at the same time rather than in sequence.
Khan said the FDA could allow pediatricians to provide vaccine to small children "off-label" – for uses other than those approved – as other medications are provided to children off-label after authorization in adults.
The data provided indicates that vaccine is safe at a 3-microgram dose being tested in children under 5.
The FDA and Pfizer-BioNTech have not been transparent, said Melissa Braveman, a pediatrician in Washington state and mother of two small children.
Releasing more specifics would help parents decide whether to get their child vaccinated, Braveman said.
If a vaccine was only 30% effective against severe disease and complications, she would get her children vaccinated, Braveman said, because "even modest protection is better than no protection, particularly with a vaccine and dosage that have already been demonstrated to be extremely safe."
Some parents of older children might let them get a higher vaccine dose – at the risk of a short-term fever – to provide protection. Children 5 to 11 are authorized to receive a 10-microgram dose, but Pfizer-BioNTech found that dose led to more fevers in younger children, so they went with the lower one.
"There's really a lot of room for us to think more creatively about solutions," Braveman said.
Pfizer vaccine for kids: The backstory
In December, Pfizer-BioNTech said early data from their trial in under-5s showed their vaccine did not boost the immune system as well in 2- to 4-year-olds as it did in older children and adults. The companies said they wanted to try a third dose, to see whether that would improve effectiveness, as it has in adults.
In late January, the FDA said enough evidence supported considering two doses for the youngest children, and data on a third would come later.
The FDA reversed course Feb. 11, saying data from the wildly contagious omicron variant suggested it was best to wait until the children in the trial could receive three doses. Neither the companies nor the FDA released detailed information to support their conclusions.
Pfizer-BioNTech said they expect the full data will be available in early April.
Other vaccine makers have been further behind Pfizer-BioNTech in studies of young children, though Moderna said in January it expects to report data in children ages 2-5 in March.
Vaccines for the youngest children are urgently needed, despite the drop in cases as the omicron surge eases, Dr. Peter Marks, the head of the FDA's Center for Biologics Evaluation and Research that evaluates vaccine candidates, said in a news conference last week.
"There's still a staggering number of cases," he said, and always the possibility of a new variant. Parents of young children should make sure they're vaccinated themselves and continue to mask in public indoor settings, he added.
The FDA has to follow a careful process to ensure children are safe and well protected, he said.
Marks promised the FDA would consider vaccine data as it becomes available and schedule a meeting of its expert review panel as soon as possible after it has all the relevant information.
"We are absolutely committed to moving as rapidly as we can once we have a submission," he said.
'I don't envy FDA': What experts say
Children 6 months through 4 years old are the least likely of any age group to have a severe COVID-19 infection, though at least 1.8 million young children have caught the virus and more than 400 have died from it, according to the Centers for Disease Control and Prevention.
Particularly because the risk of severe disease in this age group is low, "it's very important to be sure that if a vaccine is used, it's safe and effective," said Dr. Jesse Goodman, a former FDA chief scientist and now an infectious disease specialist at Georgetown University and Veterans Administration hospitals in Washington.
Hopefully, a third dose will prove convincing, Goodman said.
If it doesn't, and the FDA had authorized children to get two doses, "it would be very difficult for those who had gotten this regimen," he said. "I think we need the science to tell us."
The FDA was in a tough spot but acted responsibly by postponing the decision, said Dr. Ofer Levy, head of the Precision Vaccines Program at Boston Children's Hospital and a member of the FDA advisory committee scheduled to consider vaccine for young children.
"I don't envy FDA," he said. "They are criticized for moving too slowly and too quickly."
When the advisory committee meeting was scheduled, parents felt like they were promised they would rapidly have access to a vaccine, said Dr. Shama Cash-Goldwasser, a senior technical adviser at Resolve to Save Lives, a global public health effort.
"I think what we're seeing is science working," she said. "It wasn't that the FDA has flip-flopped but that they have good, high standards about safety and efficacy, and they're consistently thinking about not cutting corners."
The communication around the postponement could have been better, though, Goodman said. "There is some concern that it confuses people or affects confidence (when public agencies change direction), but I think it's better to do the right thing. In the long run, that's always better."
What German doctors do
Some pediatricians have been vaccinating the youngest children in Germany, where it's legal to give children approved medications off-label.
Wolfgang von Meissner, a pediatrician in Baiersbronn in Germany's Black Forest, said he has vaccinated about 3,000 young children over the past nine months, starting with his own. He started "below the radar," using doses that were left over from vials of adult vaccine or unused doses about to expire.
In December, von Meissner's practice, the largest in the region, began a concerted effort to vaccinate children, including those under 5.
"We believe a 3-year-old or a 4-year-old does not have a different immune system than a 5-year-old," he said. "If you believe in vaccinating a 5-year-old, you should also do it for a 4-, 3- or even 2-year-old."
Trials that showed the vaccine was safe in young children reassured him, he said.
Parents must sign a waiver acknowledging that their children are receiving an off-label product and agreeing that they won't sue him or the government in case of injury.
Von Meissner said he has seen nothing worse in the small children he's vaccinated than a skin rash and a day or two of low fever – fewer side effects than he's observed with many other vaccines.
"I've seen most of the kids for a second shot," he said, and parents haven't complained about side effects. "They all tell me it was an easy vaccine, not comparable to measles or tetanus or the others they have to get."
Germany is enduring a wave of omicron infections, he said, as well as BA.2, another variant, so vaccinating children could help contain the pandemic.
"You weigh the risk of infection and risk of vaccination," von Meissner said. "It's always the vaccination that wins from our point of view."
Contact Karen Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at Paste BN is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.