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Unclear labeling and disorganized storage can lead to the wrong dose of a COVID-19 vaccine being administered to a child.
The effort to boost COVID-19 vaccination rates for children in the 5- to 11-year old and 12- to 17-year old age groups will be hindered if parents and guardians aren’t assured that children are getting the correct dosing amounts, warns a watchdog organization that monitors safe medication practices. The Institute for Safe Medication Practices (ISMP), an affiliate of the ECRI Institute, states in an alert that the last thing it wants to result from its warning is fewer children getting vaccinated. Children getting less of the vaccine than they should be getting won’t be harmed in any way, they just might not be as fully protected against SARS-CoV-2 as they should be.
ISMP states that it doesn’t want to “undermine public health efforts to have as many children vaccinated as possible,” adding that the dosing errors it flags “are not expected to cause serious adverse events, and children receiving underdoses can be revaccinated.”
According to the Centers for Disease Control and Prevention, about 61.2% of the total U.S. population have been fully vaccinated. Children are the least fully vaccinated: 53% for those from 12 to 17 years old. Only 14.7% of children from 5 to 11 years old have been vaccinated.
Unclear labeling can lead to the wrong dose of a COVID-19 vaccine being administered to a child. “Simply put, the vaccine vial with the purple cap (intended for individuals 12 years and older) should never be used to prepare doses for children 5 through 11,” the alert states.
Unfortunately, that seems to be happening.
ISMP states that “reports of mix-ups with the Pfizer-BioNTech COVID-19 vaccine formulation intended for individuals 12 years and older (30 mcg/0.3 mL) have been pouring in. Most of the mix-ups occurred in outpatient or ambulatory care settings such as public health clinics, community pharmacies, physician practices, and outpatient clinics.”
Infection preventionists (IPs) usually work in hospital settings, but the COVID-19 pandemic spurs a demand for their expertise (and in some cases IPs themselves) beyond the hospital. In addition, IPs often work closely with local, state, and federal health care authorities when it comes to monitoring and controlling infectious disease outbreaks.
The ISMP alert states that there have been hundreds of reports of children 12 to 17 years old getting the dose meant for children 5 to 11, and vice versa. Because not all adverse events are reported, ISMP said the mix-up could be affecting thousands of children.
Children from 5- to 11-years old should get a dose of the Pfizer/BioNTech vaccine of 10 mcg/0.2 mL. Children from 12- to 17-years old should get 30 mcg/0.3 mL. The label on the formulation for the 5- to 11-year-old age group has a big warning DILUTE PRIOR TO USE that might cause those administering the vaccine to overlook just who it’s for.
“The 30 mcg/0.3 mL adult formulation vial has a purple cap, while the 10 mcg/0.2 mL pediatric formulation has an orange cap,” the ISMP alert states. “While different color caps might help prevent some mix-ups, once the cap is removed and discarded, doses may be prepared one at a time rather than all at once, which will render the cap color irrelevant. Also, it is unlikely that the vial will accompany prepared syringes, so the vial label cannot be verified by those administering the vaccine or parents/patients receiving the vaccine.”
ISMP suggests ways to prevent dosing mix-ups for youngsters. These include the following: