On September 18, Victoria Olivier brought her daughter Colette to a Walgreens in the Baltimore area for their family’s seasonal flu shot. Ahead of the appointment, her mother struck a deal with her that she would receive a treat if she cooperated, so she eagerly volunteered when the pharmacist asked who in their family wanted to go first.
However, the mood quickly changed when the pharmacist realized that she had accidentally given the young girl a dose of the Pfizer COVID-19 vaccine instead of the flu shot. The vaccine has not been authorized for children younger than 12.
Although Pfizer has been seeking federal clearance to give its vaccine to elementary school-aged children, that clearance would pertain only to children ages 5 to 11 and they would be given just a third of the dosage that has been administered to adults and children aged 12 and older.
However, in the initial stages of vaccine development at the pharmaceutical giant, researchers evaluated dosages of 10, 20 and 30 micrograms in three age groups. They ultimately decided on a lower dosage level but did test the amount that was given to Colette in the first stage of their study.
Victoria Olivier said that they were all stunned by the pharmacist's admission and that no one knew what to do. She began to fear that her daughter might need to go to the hospital or could develop life-threatening side effects from getting an adult dose. She sought advice from a 24/7 nurses’ hotline and the Poison Control Center but was unable to get straight answers about what might happen to the girl.
So far, she has not shown any major side effects. However, Johns Hopkins Division Of Pulmonary And Critical Care Medicines' Dr. Panagis Galiatsatos said that the dose does play a role in side effects. As the child receives a higher dose, he said, the probability of side effects increases. Although he believes the probability of harm is low overall, he said: “It got our attention, [the] human error, now we investigate how likely the dire outcome is."
He added that the girl should undergo close monitoring and follow up with health care professionals. When these types of mistakes come into the spotlight, he said, it can help prevent future occurrences.
The U.S. Food and Drug Administration (FDA) is aware of the incident, yet they somehow believe that the young girl should go back and get her flu shot despite what happened.
A representative of the FDA said that vaccination providers must report administration errors to the Vaccine Adverse Event Reporting System. They added: “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. We are glad to hear that the child is doing well and hope that she eventually received her flu vaccine.”
Walgreens spokesperson Phil Caruso told the media that these mistakes are “extremely rare.”
“We are in touch with the patient’s family and we have apologized. 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,” Caruso said.
Despite their worries about what may happen to the girl because of the vaccine mistake, the Olivier family has said that they are not planning to file a complaint about the incident with the Maryland Board of Pharmacy.
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