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The approved dose of the ≥12-year-old Pfizer-BioNTech COVID-19 Vaccine formulation is 0.3 ml (30 µg). 

• This formulation is authorized for individuals 12 years and older only

The approved dose of the 5 to 11-year-old Pfizer-BioNTech COVID-19 Vaccine formulation is 0.2 mL (10 µg).

• This formulation is authorized for individuals ages 5 to 11 years old only

Follow CDC-provided guidance in the situation that a child aged 5-11 has been administered Pfizer-BioNTech COVID-19 vaccine ≥12 years formulation (purple cap)/COMIRNATY:

CDC Guidance: “If 0.1 ml (10 µg) of the Pfizer-BioNTech COVID-19 vaccine ≥12 years formulation (purple cap) /COMIRNATY is administered to a child aged 5–11 years, in general, we do not recommend repeating the dose. However, since the dose cannot be assured in this smaller volume, based on clinical judgement (e.g., child received two doses of incorrect formulation), a repeat dose of Pfizer-BioNTech COVID-19 Vaccine 5-11 years formulation (orange cap) may be administered at an interval of 21 days after the dose given in error.”

Next Steps for Parents/Guardians

1. Contact Patient’s Primary Care Doctor or Pediatrician

Parents or Guardians should follow-up with the patient’s primary care doctor or pediatrician for clinical judgement and decision making to determine the best course of action for each patient.

Based on the CDC’s guidance and clinical decision making, parents and pediatricians/primary care doctors can choose to do one of the following:

• Restart the child’s COVID-19 vaccine series at least 21 days after the incorrect dose was given, OR
• Proceed with the child receiving their second dose as scheduled.

All future doses to your child should be of the 5 to 11 Pfizer-BioNTech COVID-19 Vaccine formulation.

*Parents/Guardians are not required to go to the original provider for continuation or completion of their child’s vaccine series*

Do not re-administer the first incorrect dose of ≥12-year-old Pfizer-BioNTech COVID-19 vaccine formulation at a dose of 0.1 mL (10 µg).

2. Monitor Patient for Vaccine Side Effects

Vaccine side effects occur between 1-3 days after vaccination with most occurring the day after vaccination. Side effects may include fever; chills; fatigue; pain, redness, or swelling at the injection site; headache. If any additional or more serious side effects occur or are prolonged, contact your primary care provider or pediatrician.

 

The following are additional optional steps for parents/guardians to take:

3. Report incident in Vaccine Adverse Event Reporting System (VAERS)

When the Pfizer-BioNTech COVID-19 vaccine ≥12 years formulation administered to a child aged 5-11 years is required to be reported to VAERS by a provider. Confirm that this action has been taken for any patient receiving the incorrect formulation.

About VAERS: The national system that collects reports from healthcare professionals, vaccine manufacturers, and the public of adverse events that happen after vaccination; reports of adverse events that are unexpected, appear to happen more often than expected, or have unusual patterns are followed up with specific studies.

4. Sign-up for V-safe

If the parent or guardian has not already signed up for V-safe, visit the following website to enroll: https://vsafe.cdc.gov. This information helps CDC monitor the safety of COVID-19 vaccines in near real time. Depending on your answers to the v-safe questions, someone from CDC may call to check on you or your child and get more information.

About V-safe:v-safe is a smartphone-based tool that uses text messaging and web surveys to give personalized health check-ins after you receive a COVID-19 vaccine. Through v-safe, you can quickly tell CDC if you have any side effects after getting a COVID-19 vaccine.

 

If you have additional questions or concerns related to the COVID-19 vaccine, please contact the Fairfax County Health Department at 703-324-7404.

If you have questions or concerns related to pharmacy practice, please contact the Virginia Board of Pharmacy by emailing pharmbd@dhp.virginia.gov or calling 804-367-4456