Jason Goldstein has every incentive to get his youngest child vaccinated. The 11-year-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 COVID-19 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 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 so-called 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 Mozaffarian learned about Pfizer-BioNTech’s clinical trials in Boston and reached out in early March to enroll her 10- and 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, 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 Mozaffarian, who said she and her children were happy to contribute to the science.
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 infectious-disease 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.
For healthy kids, Malley said, the risk from the disease itself is very low, and scientists want to be sure that the risk of a rare heart inflammation, linked to use of the messenger RNA vaccines, doesn’t increase at younger ages.
The risk/benefit ratio for children who have complicating factors, such as asthma or a recent bone marrow transplant, might be different, Malley said. “You might tolerate a slightly increased risk from the vaccine.”
The CDC’s vaccine data suggests about 200,000 children under the age of 12 have received at least one dose of a coronavirus vaccine, as of this week. Those numbers are significantly higher than the number enrolled in publicly announced clinical trials. Pfizer-BioNTech originally sought to include about 4,500 children and the FDA recently asked the company to increase the number by 3,000.
A CDC spokeswoman said she did not have specific information about why the reported numbers were so high but said that birthdays may have been incorrectly entered into the database.
Adding to the confusion are the different rules in some other countries. A number of Canadian provinces, including Ontario, Saskatchewan, British Columbia, Manitoba and Alberta, have opened up vaccines to 11-year-olds born in 2009. Quebec is also considering expanding eligibility.
Yvonne Maldonado, a Stanford professor who is chair of AAP’s Committee on Infectious Diseases, also expressed concern about off-label use as scientists are still assessing the delicate balance of dosing with immune response.
“In children, what we are seeing is you don’t need the same high dose to get a good immune response,” Maldonado said.
Maldonado said she worried that pediatricians may try to take the dosage matter into their own hands.
“They may think about taking an adult dose and dividing it up,” Maldonado said. “We don’t want clinicians and pharmacies experimenting on children.”
Ilan Shapiro, a Los Angeles pediatrician, says he’s been bombarded by parents’ questions since the Pfizer-BioNTech shot secured full FDA approval Monday, including from roughly 20 who wanted their ineligible children to receive a jab off-label.
“I always let them know, ‘First of all, I’m a human. After that, I’m a father and husband, and after that I’m a doctor, and I wish I had a different answer, but we just need to wait a little bit,'” said Shapiro. “There’s sometimes frustration but it’s a normal frustration. It’s like, ‘We are going back to school, and I want to give them the best tools to go back in a safe manner.'”
The Washington Post’s Fenit Nirrapil, Jacqueline Dupree and Lena H. Sun contributed to this story.