In the two months since Pfizer-BioNTech was granted emergency use authorization for its COVID-19 vaccine in children 5 to 11 years of age, the Institute for Safe Medication Practices (ISMP) has received multiple reports of mix-ups between the pediatric formulation and that for individuals 12 years of age or older.
Fortunately, pharmacists can use several vaccination handling and administration techniques to help reduce the risk for confusion, according to ISMP and other safety experts.
The pediatric dose of the Pfizer-BioNTech COVID-19 vaccine is 10 mcg per 0.2 mL after dilution, compared with 30 mcg/0.3 mL for those 12 years of age or older. The pediatric formulation is shipped in a multiple-dose vial with an orange border on the label and an orange cap, whereas the formulation for ages 12 years and older comes in a vial with a purple 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,” noted the ISMP alert. “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.”
Problems Surfaced Quickly
“Since the pediatric dosing received the EUA, we have received a number of reports of younger children receiving the vaccine for adolescents and adults, and vice versa,” said Rita Jew, PharmD, ISMP’s vice president of operations. “This is similar to what we’ve seen in mix-ups between adult and pediatric vaccines in general; but because a lot of people are getting the COVID vaccines in a short period, we seem to be seeing more of these reports at one time.”
Dr. Jew added that no serious adverse events related to vaccine dose mix-ups have been reported to ISMP, but that doesn’t mean there isn’t cause for concern. “During the phase 1 clinical study, younger children were randomized to receive a vaccine dose of up to 30 mcg. Increased reactogenicity was observed with higher dose levels, and systemic events for the 30-mcg dose were deemed unacceptable,” she explained. Given those findings, “there is an obvious [risk for] adverse reactions in young children who receive higher doses.”
But there is “another significant concern,” she stressed—the “limited protection” that may result when older children aged 12 and up “inadvertently receive the lower dose of the vaccine rather than the higher dose they need for optimum protection.”
The pediatric and adult vaccines are also delivered in different injection volumes, which has caused some confusion. As noted, the 12-and-up dose of 30 mcg should be diluted to a volume of 0.3 mL (yielding approximately six doses per vial), whereas the pediatric dose of 10 mcg should be diluted to a volume of 0.2 mL (yielding approximately 10 doses per vial). “We have had a handful of reports stating that pediatric patients may have received 0.3 mL of the pediatric vaccine, as well as a couple of reports where 12 years-and-older patients may have received 0.2 mL of the adult vaccine,” Dr. Jew said.
Other errors have occurred in vaccinating children who are near their 12th birthdays. “If a patient turns 12 between receiving the first and second injections of the vaccine, their first injection should be at the pediatric dose and their second at the 12-years-and-up dose.” (See box for more strategies for avoiding mix-ups.)
The Pfizer-BioNTech age-related doing mix-ups were reported through the ISMP National Vaccine Errors Reporting Program (VERP), which is separate from the federal Vaccine Adverse Event Reporting System (VAERS). Providers should report all vaccination errors internally, as well as to VAERS, which is mandatory for products under an EUA, ISMP noted. The group requested that the errors be reported to VERP as well.
Cast a Wide Safety Net
Incorporating medication safety strategies into all aspects of vaccination processes—at the system, hub site and clinic levels—can help safeguard against age-related dose mix-ups, noted Lorrie Burns, PharmD, a medication safety pharmacist at OhioHealth Riverside Methodist Hospital, in Blacklick. At the ASHP 2021 Midyear Clinical Meeting, Dr. Burns presented a poster on OhioHealth’s experience with such an approach for the first phases of the COVID-19 vaccine rollout.
In the initial five-month period of the public vaccine rollout, beginning Jan. 19, 2021, OhioHealth administered 173,028 vaccine doses during 850 vaccine clinic sessions held at 35 clinic sites within its system. The strategies implemented include:
an online pharmacy “Vaccine Playbook,” continuously updated;
a document developed by a medication safety pharmacist for use by the system’s vaccine steering committee; competency and training modules for pharmacy and nursing vaccinators;
incorporating a system medication safety pharmacist into clinic staffing, assisting with vaccine dispensing and process improvements; supply checklists, which later evolved into clinic “packing slips,” detailing vaccines and supplies for each clinic;
lot control strategies and vaccine-specific syringe labels; and
a group chat application for resources and communication between hub and clinic sites.
Staffing all vaccine clinics with a medication safety pharmacist was a particularly effective strategy, Dr. Burns said. “It helped us to be both more efficient and more safe to have pharmacists in every vaccine clinic who had process improvement strategies as a part of their professional focus.”
ISMP’s 6 Tips for Reducing COVID-19 Vaccine Mix-Ups
Store adult and pediatric vaccines apart, such as in separate labeled plastic bins.
Use barcode scanning wherever possible to verify that the correct product has been retrieved. “I would emphasize leveraging barcode scanning technology as you are preparing these vaccines to validate that you do indeed have the appropriate vaccine for the patient age in hand,” said Rita Jew, PharmD, ISMP’s vice president of operations. “This is the highest-level strategy we would recommend to prevent these errors.”
Make it a policy to clearly label all individual syringes containing vaccines. Print labels for each patient or provide vaccine preparers with strips of preprinted labels that differentiate adult and pediatric doses.
Take only 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. “Often, the age mix-up involves not really validating the age of the patient by double-checking with the parent or guardian or validating the patient’s date of birth in the medical record,” Dr. Jew said.
Document the lot number and date of manufacture of the vaccine before vaccine administration, and document administration after the vaccine has been given in the patient’s profile, on the vaccination record, and via state or other immunization registries. Source: ISMP
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