Paediatric Pfizer Preparation of doses

The Paediatric Pfizer COVID-19 Vaccine for children/tamariki aged 5 to 11 years comes as a concentrate and must be diluted on site, following the instructions provided by IMAC. These instructions are included in vaccine shipments and available on the IMAC website.

The dilution for the Paediatric Pfizer dose is different from the dilution for ages 12 years and older Pfizer dose.

Note: These instructions are regularly updated. Please ensure you are using the most recent version.

BioNTech/Pfizer COVID-19 Vaccine should be brought to room temperature prior to dilution, as noted in IMAC’s preparing vaccine instructions. It should not feel cold to the touch. The actual time to get the vial to room temperature will vary depending on when you take vials out of the fridge and the temperature of the room. Approximately 30 minutes should be sufficient time.

Please note the BioNTech/Pfizer COVID-19 Vaccine is fragile and must not be shaken during preparation. However, once the vial has been fully thawed, it can be gently inverted ten times to reduce condensation.

Before preparation check:

• correct vaccine must be confirmed. The vial has an orange-coloured cap on top of the vial and the label has an orange border and orange writing ‘mRNA-CV 10g. • manufacturer’s vaccine expiry date • the appropriate supplies are used: o 1mL syringe with 16mm or 25mm needles o syringe labels

It is recommended that a suitable covering is used when storing the drawn-up syringes. This is to ensure:

1. That at all times, the vaccine is not exposed to direct sunlight or UV light (both in the vial and in the drawn-up syringe).

2. That used syringes will not be put back with the unused syringes.

If during the preparation of the vaccine a foreign body (such as a black particle) or discolouration is identified, the vial should be discarded and recorded as an open vialquality issue in CIR.

Number the vaccine vial and enter the number into the vaccine log. Second person also cross checks that the correct vaccine has been selected, by confirming the product name on the vial and checking the expiry date printed on vial by manufacturer. Second person

also cross checks the numbering of the vial and documents these checks by signing/initialling the vaccine log.

For quality and safety purposes, after diluting the vaccine, it is recommended that each vial and/or syringes (made from that vial), are labelled with the:

• diluent name • date and time of dilution • expiry time after dilution

Syringe labels have been introduced to help differentiate between vaccines.

• The syringe Label for Pfizer Paediatric Vaccine (5-11 years) and an example on how the labels could be used is below:

Only draw up one vial at a time, each vaccine from that vial should go into one container with the original vial for vaccine delivery. Do not mix doses from different vials.

During the preparation of the vaccine standard local IPC policies should be followed.

Note: During the preparation of the vaccine both expiry dates must be double checked. This includes the vial and the 10-week removal from ULT expiry date. Vaccines can be administered until the end of the expiry day.

22.1 Number of doses per vial for age 5 – 11 years

The Medsafe data sheets confirms ten (10) doses per vial however, there is technically enough vaccine in a vial to draw up eleven (11) doses using Low Dead Space (LDS) syringes. It is safe to use the vaccine in the 11th dose providing that you are totally confident that you have measured the saline correctly for dilution, that each dose of vaccine has the full 0.2mLs, and that the drawing up and administration of the vaccine uses the same needle as instructed.

LDS syringes are to be used with the Paediatric Pfizer vaccine. If LDS syringes are not available for use, contact IMAC on 0800 466 863 for advice.

To avoid the Paediatric Pfizer vaccine being under or over diluted it is recommended that all doses are drawn up into syringes following dilution and double-checked by a second appropriately trained vaccinator.

If the number of doses drawn from the vial are not in line with expected number this will immediately alert to the vial having not been correctly diluted. Any vial where doses drawn up are less than ten (10) or more than eleven (11) in number, should be quarantined. Use of the IMAC dilution record spreadsheet will also provide an additional check.

Please discuss with IMAC on 0800 466 863 and if advised to discard, this must be documented as waste in CIR as per guidelines and reported as an incident in the local organisation’s quality and safety reporting system.