HORSHAM, PA—With the approval of a COVID-19 vaccine for young children, the Institute for Safe Medication Practices (ISMP) is warning about the possibility of mix-ups between the pediatric formulation and the formulation for individuals 12 years old or older, since both will be available at many vaccination sites. Unfortunately, age-related mistakes with other vaccines have been linked to more than 1 in 3 errors reported to the ISMP National Vaccine Errors Reporting Program (VERP). ISMP does not want this information to cause hesitancy about vaccination, but is urging healthcare practitioners and caregivers to take steps to help prevent errors.

The U.S. Food and Drug Administration (FDA) has authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 years, and the Centers for Disease Control and Prevention (CDC) is recommending vaccination for children in that age group. This allows for immediate distribution of the pediatric vaccine to physician offices, pharmacies, and clinics, so vaccinations could begin as early as this week. The pediatric vaccine will be supplied in a multiple-dose vial with an orange label border and vial cap, while the formulation for ages 12 and older has a purple vial cap and label border. However, once the cap is removed or discarded doses may be prepared one at a time rather than all at once, making cap color irrelevant. Also, it is unlikely the vial will accompany prepared syringes, so the label cannot be verified by individuals administering the vaccine or parents/patients receiving it.

Previous experience with vials available for pediatric and adult hepatitis A and hepatitis B vaccines, which use color differentiation, has demonstrated that different color caps and labels may not prevent errors. ISMP recommends sites administering the adult and pediatric COVID-19 vaccines take the following steps to reduce the risk of mix-ups:

• Develop a plan for segregating and storing the vaccines in refrigerators and freezers that are organized and properly labeled. Adult and pediatric vaccines should be stored apart from one another, such as in separate labeled plastic bins.
• During production and/or verification phase of the vaccine dispensing process, use barcode scanning wherever possible to verify that the correct product has been retrieved.
• Make it a policy to clearly label all individual syringes containing vaccines. To facilitate proper labeling, print labels for each patient or provide vaccine preparers with strips of preprinted labels that differentiate adult and pediatric doses.
• Only bring the intended and labeled COVID-19 vaccine syringe(s) for one patient into the vaccination area at a time.
• Involve the parent of the patient in verifying the vaccine by reading the labeling to confirm that the correct one is being administered.
• Document the lot number and date of manufacture prior to vaccine administration, and document administration afterwards in the patient’s profile, on vaccination records, and via state or other immunization registries.
• Report all vaccination errors internally as well as to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS), which is mandatory for products under an emergency use authorization. ISMP also asks providers to report vaccine errors to ISMP's VERP and Pfizer, which manufactures the COVID vaccines for BioNTech.

For a copy of an ISMP safety brief on the new pediatric COVID-19 vaccine formulation, click here.

About the Institute for Safe Medication Practices

The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 25 years, it also has served as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP formally affiliated with ECRI to create one of the largest healthcare quality and safety entities in the world, and ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As an independent watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its life-saving work. Visit www.ismp.org and follow @ismp_org to learn more.

For more information, contact:
Laurie Menyo, Director of Strategic Communications
610.825.6000 ext. 5310
lmenyo@ecri.org