Using COVID-19 Vaccine Pfizer-BioNTech as part of the Schools Vaccination Programme for 12-15 year olds

Tim Root, Assistant Head, Medicines Assurance, NHS Specialist Pharmacy Service, Specialist Pharmacy ServicePublished

Requirements specific to the Pfizer-BioNTech, (Comirnaty® and unbranded R174 product) vaccine when used for the COVID-19 schools vaccination programme.

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

Handling

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.

Dilution

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 It must be further diluted with preservative free sodium chloride 0.9% before being withdrawn into syringes for administration.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.

Full process

Pfizer has produced a training video which shows the correct handling and preparation of the COVID-19 Vaccine Pfizer-BioNTech.  SPS has also produced a training video for further support.

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.

Pfizer-BioNTech process flow:  management of vaccine immediately before and during a vaccination session

SOPs, work instructions and checklists to adapt

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