The error was reported because Pfizer-BioNtech submitted clinical trial data from a COVID-19 vaccine study among children 5-11 years of age to the FDA.
A 4-year-old girl in Maryland was reportedly accidentally given the first dose of the COVID-19 vaccine, instead of the seasonal flu shot she was scheduled to receive at her local pharmacy.
According to baltimore sun, Victoria Olivier brought her daughter to get a flu vaccine this month, though a Walgreens pharmacist instead gave an adult dose of the Pfizer COVID-19 vaccine, which has yet to be approved by the Food and Drug Administration (FDA) for Children. has not been approved. 12.
Walgreens spokesman Phil Caruso told Granthshala News in an email that patient safety is the company’s “top priority.”
“Incidents like these are extremely rare and we take this matter very seriously,” Caruso wrote in a statement. “We have been in contact with the patient’s family and have apologized. Our multi-step vaccination process includes multiple safety checks to reduce the potential for human error. To prevent a future incident, we have recently Have reviewed this process with your pharmacy staff.”
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The error comes when children under the age of 12 remain ineligible for the vaccine, although Pfizer-BioNtech has submitted clinical trial data from a COVID-19 vaccine study among children ages 5-11 to the FDA. has been introduced, the companies announced on Tuesday. The request for emergency approval is expected to follow in the coming weeks, Granthshala News informed of. The trial data included findings from 2,268 participants aged 5-11, which suggested the small-dose shot was safe, well tolerated and resulted in neutralizing antibody responses.
Olivier told the Baltimore Sun that he and his family are “shocked” by the incident. He had apparently dialed the 24/7 nurse’s hotline, Poison Control, and contacted Olivier’s network of social media friends for help. So far, the baby hasn’t had any major side effects, news outlets informed of.
In a statement to Granthshala News, the FDA reminded that it has not “evaluated data relating to the safety and effectiveness” of the Pfizer vaccine for use in children under the age of 12, nor has it “evaluated data concerning the safety and effectiveness” of that pediatric population. has approved or authorized the emergency use of the vaccine. .
“We are delighted to hear that the child is doing well and hope that he or she will eventually receive the flu vaccine,” the spokesperson wrote in an email. “In accordance with the Vaccination Provider Agreement, it is mandatory for vaccination providers to report vaccine administration errors, whether or not associated with an adverse event, to VAERS. [The Vaccine Adverse Event Reporting System]”
Olivier is family Allegedly Maryland does not plan to file a complaint with the Board of Pharmacy.
Granthshala News’ Kayla Rivas contributed to this report.