Doctors besieged by parents seeking shots for kids under 12
Jason Goldstein has every incentive to get his youngest child vaccinated. The 11year-old has health issues that could make COVID-19 particularly dangerous for him.
But the Baltimore pediatrician is abiding by the same advice he has given to the 50 or more parents who have called him recently. “We all want our children to get the best protection.” he said. “And just as much as we want to do it, we want to do it in the safest way possible. We’ve got to wait for the data to play out.”
As the start of the school year nears, pediatricians say they are being deluged by calls from anxious parents, who are eager to get their children vaccinated against the virus that continues its deathly rampage, especially as the delta variant appears to exact a greater toll on kids. Some parents are seeking ways to get the shots before federal officials give the go-ahead, with more than 2,100 children with COVID19 hospitalized, according to a Washington Post analysis of federal data.
While the Pfizer/ BioNTech vaccine is authorized for children 12 and up and was fully approved this week for anyone over 16, it isn’t clear when younger children may be eligible to roll up their sleeves. The Food and Drug Administration’s timetable for authorizing shots for younger children ranges from later this year to early next.
“It’s hard,” said Dr. Goldstein, who says he has heard anecdotally of parents lying about their children’s ages to get them access to the vaccine, even as he and his colleagues at Pavilion Pediatrics stick by government guidelines.
Public health bodies and professional organizations, from the Centers for Disease Control to the American Academy of Pediatrics, are strongly discouraging socalled off-label use of the vaccines in children, warning they have not been fully tested in this younger age group and that doctors who administer them may open themselves to lawsuits in the event of unexpected side-effects.
“Providers may not have immunity from claims” the CDC warns on its website, and they may face “other potential sanctions.”
The American Academy of Pediatrics posted a cautionary note prominently on its website Monday to warn against off-label use, in response to a flood of questions from doctors who had, in turn, been fielding calls from parents.
“From a safety standpoint, it’s really important to wait,” said Lee Savio Beers, the group’s president. One of the things the vaccine trials will determine is the effective dose for children aged 5 to 11, she said, emphasizing the importance of following the authorization and approval process.
“From all that we are hearing, we do believe that the recommended dose will be lower than for adolescents 12 and up,” said Beers, who repeated the group’s call on the FDA to act as quickly as possible.
Still, some parents are scouting for doctors who will make an exception for them. One mom posted an article on Facebook Wednesday that said it’s “technically legal” for physicians to give the vaccine to children under 12. “Anyone know of a physician currently doing this?” she wrote. “I’m desperate to get my 11.5 year old vaxxed before returning to school.”
Tanya Satalino, a mother of three from Connecticut, said she has been “stalking the news” for vaccine information for her 10-year-old daughter. She said she is not seeking to get the shot off-label because she believes the vaccine for younger children should be fully vetted by the FDA’s experts, but she will sign up the first day it’s authorized.
“It’s just scary now if you’re not vaccinated,” she said. “I hope they won’t delay it any longer.”
Rebecca Mozaffarian, a project manager in the department of nutrition at Harvard T.H. Chan School of Public Health, got an early sense of how eager many parents are to get their children the shots.
After Ms. Mozaffarian learned about Pfizer-BioNTech’s clinical trials in Boston and reached out in early March to enroll her 10and 8-year-olds, she started hearing from friends asking, “How can I get on that?”
The waitlist was full and the timeline tight. After another family opted out, Ms. Mozaffarian heard on June 8 that her two younger children had been accepted into the study and had to show up two days later for the first shots, not knowing whether they would be receiving the vaccine or a placebo.
“I have talked to parents that were nervous about vaccines for their kids,” said Ms. Mozaffarian, who said she and her children were happy to contribute to the science.
Dr. Adrienne Randolph, a professor of pediatrics at Harvard Medical School and a physician at Boston Children’s Hospital, said she doubted most U.S. pediatricians would be persuaded to give the shots off-label to children younger than 12.
“It could be some may consider moving the needle down to 11, but I don’t see pediatricians breaking the rules because they usually don’t for things like vaccines,” she said.
Rick Malley, an infectiousdisease expert at Boston Children’s, said the FDA’s authorization process needs to play out to assess the risks and benefits, as is done with every vaccine.
“You don’t want to make assumptions that something safe in a 25-year-old is safe in a 2-year-old,” he said.