Storing vaccine appropriately
Effective process control is essential to ensure that vaccines are stored correctly and new expiry dates and times are allocated.
Storage prior to dilution
COVID-19 Vaccine Pfizer-BioNTech may be stored for up to 31 days between 2ºC and 8ºC, followed by an additional 2 hours at room temperature.
Storage subsequent to dilution
After dilution the vaccine should be used as soon as practically possible and within 6 hours.
Effective process control is essential to ensure that vaccines are stored correctly and new expiry dates/times are allocated with further Information and guidance specific to COVID-19 Vaccine Pfizer-BioNTech available to support this.
Handling and preparing vaccine
Delivery of vaccine to supply hubs will be at Ultra Low Temperature (ULT) where vaccine should be labelled with a 31-days shelf-life and transferred to a dedicated fridge for thawing.
- Onward supply to school vaccination sites or teams will be at 2-8C in coolboxes in response to orders/requisitions to the hub..
- The exact number of vials ordered by end users should be packed securely in a coolbox immediately before onward supply.
- Packing down of quantities less than an original pack of 195 vials for stock to be stored in anticipation of orders should NOT occur.
The COVID-19 Vaccine Pfizer BioNTech is a multi-dose vial containing a concentrate. It must be further diluted with preservative free sodium chloride 0.9% before being withdrawn into syringes for administration.
- Robust systems are required to prevent inadvertent administration of the concentrate vaccine.
- Ensure vials of concentrate are effectively segregated from diluted vials.
- Only one vial of vaccine should be in use at any one time.
Each step of the process described changes the vaccine characteristics that will require a change in the shelf life. This requires diligent process control to ensure the vaccine is safe and effective at the point of use.
Handling process for Pfizer-BioNTech vaccine immediately before and during a vaccination session
Vials of concentrate must be segregated from the in-use diluted vial
Work with one vial at a time to prevent preparation and selection errors.
The vial must be used as soon as practically possible, and within 6 hours of dilution
Each diluted vial contains sufficient vaccine for 6 doses.
These should be drawn up and provided to the vaccinator (or administered directly) one by one.
Filled syringes must never be allowed to accumulate on the workstation, and must never be left unattended.
Local measures will need to be taken to minimise the risk of needle stick injury.
Vials should not be retained between sessions.
Vaccines must not be returned to the fridge.