The approval of the Pfizer Comirnaty Orange Cap (5-11 years) COVID-19 vaccine to be administered by pharmacists from 10 January 2022 offers opportunities and challenges for pharmacists. PDL encourages pharmacists to prepare for this service now and consider the following to minimise risk.
Preparation and administration key points
- Comirnaty (Orange Cap) is a specifically formulated paediatric vaccine provisionally approved by TGA in the 5–11-year-old age range.
- Comirnaty (Orange Cap) is the only vaccine approved for this age group at time of this alert.
- The paediatric vaccine is supplied in a 10-dose vial and requires dilution with 1.3mL of normal saline (this is a different dilution volume to Pfizer Comirnaty Purple Cap).
- Primary vaccination schedule is TWO doses of Comirnaty (Orange Cap) 10µg = 0.2mL
- The recommended interval between primary doses is 8 weeks.
- The 8-week interval between doses can be shortened in special circumstances to a minimum of 3 weeks. This is recommended in situations such as an outbreak response, prior to the initiation of significant immunosuppression or prior to international travel.
- The dilution volume, final concentration for administration and components (excipients) of the Orange Cap formulation differs from the adolescent/adult (Purple Cap) formulation.
- Children who turn 12 after their first dose may receive the adolescent/adult formulation of the Pfizer COVID-19 vaccine to complete their primary vaccine course.
- Pharmacy staff involved in any aspect of this service need to review the specific training available for Pfizer Comirnaty Orange Cap 5-11 years vaccine before providing the service.
- Review the ATAGI recommendations on the use of the paediatric Pfizer COVID-19 vaccine in children aged 5 to 11 years in Australia for further information.
- Comirnaty (PURPLE CAP – Adult formulation) is NOT SUITABLE for use in the 5-11-year-old cohort – DO NOT USE THE PURPLE CAP VACCINE FOR CHILDREN UNDER 12 YEARS.
Pharmacists currently qualified to administer vaccinations can provide this service to individuals of any age, subject to State or Territory legislation. Check your local jurisdiction has approved the administration to children in this age range before starting the service.
Risk management considerations
- Ensure pharmacy protocols are upgraded to differentiate between all vaccines available, dose volumes, dilution volumes and interval periods.
- Use logical systems to identify different brands and strengths of vaccines. Consider allocating certain days or sessions within a day for one vaccine to minimise error.
- Take care when accepting walk-ins as this has been a contributing factor in incidents.
- If the pharmacist or child is uncomfortable with the prospect of vaccination, consider deferring the service or referring to a practitioner better suited to provide the service.
PDL suggests checking the A.I.R before administering all types of vaccines. This will confirm the patient’s vaccination history, age, interval between doses and brand of past vaccine.
For immediate advice and incident support, call PDL on 1300 854 838 to speak with one of our Professional Officers. We are here to support our pharmacist members 24/7, Australia-wide.
