Before heading out the door on the morning of Sept. 18, Victoria and Martin Olivier and their 4-year-old daughter struck a deal.
In exchange for good behavior during the family’s pharmacy visit for seasonal flu shots, Colette could expect a sugary treat in her future. So when the Walgreens pharmacist asked “Who wants to go first?” and Colette bravely sprang up to volunteer, her parents felt a wave of relief wash over them.
But relief soon gave way to panic when the pharmacist realized she injected Colette with a dose of the Pfizer/BioNTech COVID-19 vaccine, which is not yet authorized for children younger than 12.
Last week, Pfizer said it would seek clearance from federal regulators in the coming weeks for elementary school-aged children, 5 to 11 years old, to receive the shots — but only for a regimen of about a third of the dosage given to adults and kids ages 12 and older.
The resulting quandary represents a snapshot of the daily challenges, questions and uncertainties parents encounter as they navigate the ongoing public health crisis with their children. The past 19 months have pushed families to their limit as they balance the benefits and potential risks of a world altered by the pandemic.
Once-mundane trips to visit out-of-state relatives or go to classrooms and even pharmacies have become sources of anxiety as recommendations on social distancing change, mask mandates come and go, and new strains of the coronavirus emerge, threatening to upend the progress made toward ending the pandemic. People who are unvaccinated constitute nearly all those currently hospitalized for COVID-19 in Maryland and elsewhere, including children.
Olivier called the pharmacist’s admission of error a “record-scratch” moment that she feared could have dire implications for her daughter: Did Colette need to go to the hospital? Would she develop life-threatening side effects from the adult dose? Did they now need to schedule a second-dose appointment for her?
“All of us were just stunned,” Olivier said. “No one really knew what to do, of course.”
The Olivier family raced home and began digging through internet-based resources. A 24/7 nurse’s hotline and Poison Control yielded few answers. She turned to a robust network of social media friends for help.
Colette, meanwhile, went about her day.
“I got the first COVID shot,” the little girl said proudly Wednesday night as she swung on a neighborhood playground swing in Remington.
Afterward, she said, she got Italian ice, even though she really prefers cake.
All that was left of the pharmacy visit is the bandage, which she was scared to rip off. The child ran around the playground barefoot, discarding her small pink Crocs.
So much of her childhood has been dominated by the coronavirus pandemic, which swept the world starting when Colette was 2 1/2 and her sister, Sylvie, was newly born. For a time, the family remained at home together until the children returned to in-person day care and prekindergarten. At school, Colette’s drawings often include people wearing masks, her mom said.
The Olivier parents have become experts at gently communicating the pandemic’s dangers to their girls. It’s a balance of being honest without scaring them, Olivier said.
“It’s part of growing up now,” she said. “We tell her we’re doing everything we can to protect ourselves. Sometimes she’ll ask, ‘When is the end of the pandemic?’ and the best I can say is, ‘We need more people to get the vaccine.’”
That’s why Colette delighted in her unexpected immunization status. She felt special, her mom said, knowing she did her part to help the world heal. She hopes to get her flu shot soon.
Little guidance exists for parents who find themselves in this situation. A representative from the U.S. Food and Drug Administration, the federal regulatory body, said it is mandatory for vaccination providers to report vaccine administration errors, whether or not associated with an adverse event, to the federal government’s The Vaccine Adverse Event Reporting System.
“FDA has not evaluated data pertaining to the safety and effectiveness of the Pfizer-BioNTech COVID-19 Vaccine for use in children younger than 12 years of age, nor has FDA approved or authorized the vaccine for emergency use for this pediatric population,” the spokesperson said. “We are glad to hear that the child is doing well and hope that she eventually received her flu vaccine.”
Walgreens spokesperson Phil Caruso said such mistakes are “extremely rare.” The company’s top priority is patient safety, he said.
“We are in touch with the patient’s family and we have apologized,” Caruso said. “Our multistep vaccination procedure includes several safety checks to minimize the chance of human error. We’ve recently reviewed this process with our pharmacy staff in order to prevent a future occurrence.”
Experts in pediatrics, immunology and biology said the pharmacy’s blunder, while frightening, was not life-threatening, nor should it dictate how other families feel about seeking medical care or vaccinations for their children.
“That’s not going to happen often,” said Brian Castrucci, an epidemiologist and president and CEO of the de Beaumont Foundation, a public-health-focused charitable organization based in Bethesda. “We should never have an error in our care, but this is an error that caused no harm. This isn’t a poison.”
In initial stages of the Pfizer vaccine’s development, researchers evaluated three different dosage levels — 10, 20 and 30 micrograms — in three age groups. Though it ultimately did not select the highest dosage level for the 5-to-11 age group or younger, the company did test the 30 microgram dose in children in the first stage of the study.
Regulators go to great lengths to prevent mistakes in administering medications and therapeutics, setting rules and standards for everything from manufacturing to labeling and packaging.
Medication errors, which include biological products and prescription drugs, affect some 100,000 people each year, according to the FDA. Many more go unnoticed or undetected.
The Olivier family said they contacted representatives at Walgreens asking for Colette’s immunization record to reflect the COVID-19 shot. They are not planning to file a complaint with the Maryland Board of Pharmacy, which would investigate the incident for as long as six months before making a decision “to discipline or not,” said Rochen Wang, compliance investigator supervisor at the state pharmacy board, in an email.
Studies examining how toddlers and young children react to COVID-19 vaccines are ongoing, including at the University of Maryland School of Medicine, which is running a Moderna children’s trial in Baltimore.
The Olivier family said they spoke with Dr. James Campbell, the principal investigator of the Moderna vaccine in children, who reassured them that Colette would be OK. Representatives from the medical school declined to make him available for an interview.
COVID-19 vaccines are safe to inject and effective at preventing people from contracting severe illness, said Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security. Lower doses are being given to children so they can avoid some of the unpleasant side effects that accompany the shots, such as fever, chills and arm soreness, she said.
“Children tend to have much more active and robust immune responses than adults or seniors,” said Gronvall, also an associate professor at Hopkins’ Bloomberg School of Public Health. “Giving a full adult dose, they’d trigger some of the same side effects as in adults, on occasion. And you don’t want to see children go through that.”
Still, the American Association of Pediatrics “discourages” health care workers from administering vaccines in children younger than 12.
“The dose may be different for younger ages,” according to the group. “The AAP recommends against giving the vaccine to children under 12 [years] until authorized by the FDA.”
At the same time, the organization “has repeatedly called on health officials to authorize a vaccine for children under 12 years,” the association said last month.
Gronvall said people should worry more about the long-term side effects associated with contracting COVID-19 than the risk of receiving the vaccine in an off-label fashion.
“A lot of people are going to be jealous and wish that their pharmacists make a similar mistake,” she said.
Victoria Olivier said while she may not wish the same fate upon other families, she does take some comfort knowing that her daughter is at least partially protected against COVID-19 — for now, anyway. Physicians have recommended the family wait until the Pfizer vaccine is authorized for Colette’s age group before scheduling a second dose appointment.
Back at the playground, Olivier asked Colette if she had mentioned anything to her classmates about getting the vaccine. The little girl smiled.
“No,” Colette said. “I forgot to tell them.”