A Loudoun County pharmacy has been ordered to stop administering coronavirus vaccine shots after it incorrectly gave 5-to-11-year-olds formulations designed for older kids and adults, the Virginia Department of Health said this week.
The Pfizer-BioNTech vaccine, the only one so far authorized in the U.S. for children under 12, is supposed be given to them at one-third of the dosage given to adolescents, teenagers and adults.
“Because they did not have the children’s formulation they used the adult formulation but only gave a third of the amount to the children,” David Goodfriend, director of the Loudoun County Health Department, said Thursday. “Our understanding from Ted Pharmacy is they were trying to do a workaround, which is not authorized.”
The problem with the workaround, Goodfriend said, is that when the volume of vaccine given is reduced, it becomes difficult to ensure it’s the correct amount.
“If it doesn’t all go in, or if goes into the body but doesn’t go into the muscle, or you didn’t draw it up exactly to the 0.1 milliliter line, there’s a chance you might get too little vaccine,” he said. “There’s also a chance it could have given too much.”
Goodfriend said it’s unlikely a child would have been harmed by receiving too much of the vaccine, but it’s possible children were under-vaccinated if they received too little.
The issue was discovered Nov. 4, Goodfriend said. “It was a good observant parent, as I understand it, that brought it to the Virginia Department of Health’s attention.”
The parent noticed a vial’s color, Goodfriend said. The young children’s dosage comes in a vial with an orange cap, while doses for those 12 and older come in vials with purple caps or purple bordered labels.
After receiving the report, authorities collected all remaining coronavirus vaccines from the pharmacy and instructed it to notify families. The issue was first reported by NBC4 Washington.
Families nationwide have been scrambling to get their young children vaccinated ahead of the holidays. About 28 million children became newly eligible for smaller doses of the Pfizer-BioNTech vaccine after federal authorities gave the green light this month.
In the clinical trial, the vaccine was shown to be safe and more than 90 percent effective for children ages 5 to 11 during a time when the delta variant was the dominant strain, according to the vaccine manufacturer.
A letter to the children’s families Wednesday from Goodfriend included guidance from the Centers for Disease Control and Prevention, which said kids given the wrong dose could proceed with a second dose of the correct amount in three weeks, or restart the two-shot series after three weeks.
Goodfriend said the parent’s report and the response by health officials in Richmond who worked with the CDC “allowed them to come up with guidance that’s likely helping people in other parts of the country where this may have occurred.”
Ester Megally, who is listed in corporate filings as an owner of Ted Pharmacy, said she could not immediately comment when reached by phone Thursday. “It’s a working day for us now, and we are a little bit busy. I’m sorry,” she said.
State health officials said they have not received any other reports of pharmacies or health providers giving children the wrong dose.