Pfizer Preparation of doses

The BioNTech/Pfizer COVID-19 Vaccine 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.

• 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.

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.

Once the vaccine has been diluted, it must be administered within six hours. Any prepared doses not used within this time period must be discarded. Prepared doses cannot be transported to other sites.

Before preparation check: • it is the right vaccine • the ‘in-use’ expiry date label on the vaccine pack. Vaccines can be administered on day of expiry (up to midnight)

Number the vaccine vial and enter the number into the vaccine log. Second person also 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 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 all doses are drawn after dilution and each vial and/or syringes, 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 Adult Vaccine (12+ years) and an example on how the label could be used is below:

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

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.

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 31-day removal from ULT expiry date. Vaccines can be administered until the end of the expiry day.

17.1 Number of doses per vial

The expected number of doses from each vial remains at six, but there is technically enough vaccine in a vial to draw up seven doses using LDS needles. It is safe to use the vaccine in the seventh dose providing you are totally confident that you have measured the saline correctly for dilution, that each dose of vaccine has the full 0.3mls, and that you are drawing up and giving the vaccine using the same needle as instructed.

To avoid the 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.

Note: Incorrect volume of diluent may be detected by identifying you have drawn up less than six or more than seven doses from the vial. Should this occur, quarantine, and discard all doses from that vial. This error must be documented as waste in CIR and reported as an incident in the local organisation’s quality and safety reporting system.

For more information on vaccine policy statements and clinical guidance, refer to the Ministry’s website.