Requirements specific to the Pfizer-BioNTech vaccines when used for the COVID-19 vaccination service within community pharmacy settings

Authorisation for use

The MHRA’s conditions of authorisation and the information for healthcare professionals and recipients outlines the framework through which the vaccine can be used.

Storing vaccine appropriately

Effective process control is essential to ensure that vaccines are stored correctly and new expiry dates and times are allocated.

The COVID-19 Vaccine Pfizer-BioNTech is available as both Comirnaty (30micrograms/dose) concentrate for Adults and Adolescents and Cominaty (10micrograms/dose) concentrate for Children 5-11 years.

Up to date information on storage ​requirements for either product may be found in the product specific documentation.

Handling and preparing vaccine

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 It must be further diluted with preservative free sodium chloride 0.9% before being withdrawn into syringes for administration.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

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.

 

Administration

Administration requires diligent process control to ensure the vaccine is safe and effective at the point of use.

Use in relation to prior allergy

Administration requires diligent process control to ensure the vaccine is safe and effective at the point of use.

Advising individuals with allergies on their suitability for COVID-19 Vaccine Pfizer-BioNTech

Advice on whether people with a previous allergic reaction can have the COVID-19 Vaccine Pfizer-BioNTech (Comirnaty).

Process flow for vaccination session

A diagram giving an overview of the process during a vaccination session is attached below.

SOPs, work instructions and checklists to adapt

Relevant Standard Operating Procedures, work instructions and checklists are available below. These may be adapted by Superintendent Pharmacists for use in Community Pharmacy settings.

Receiving and storing both Comirnaty concentrate vaccines at PCN Designated Sites

21 December 2020SOP for receiving and storing Comirnaty concentrate for Children 5-11 years and Comirnaty concentrate for adults and adolescents at PCN sites

Preparing Comirnaty Adult and Adolescent Syringes for Administration at PCN designated sites

5 January 2021SOP for preparing Comirnaty concentrate Adult and Adolescent Syringes for Administration at PCN designated sites prior to immediate administration.

Preparing Comirnaty Children 5-11 years Syringes for Administration at PCN designated sites

21 January 2022SOP for preparing Comirnaty concentrate for Children 5-11 years syringes for administration at PCN designated sites prior to immediate administration.

Stocktaking and reconciliation of both Comirnaty Concentrate Vaccines at PCN Designated Sites

11 December 2020SOP for stocktaking and reconciliation of Comirnaty concentrate for Children 5-11 years and Comirnaty concentrate for adults and adolescents at PCN sites

Disposing of both Comirnaty Concentrate Vaccines at PCN Designated Sites

21 December 2020SOP for safe disposal of Comirnaty concentrate for Children 5-11 years and Comirnaty concentrate for adults and adolescents at PCN sites

Dealing with spillages and breakages of both Comirnaty concentrate vaccines at PCN Designated Sites

11 December 2020SOP for dealing with spillages or breakages of Comirnaty concentrate for Children 5-11 years and Comirnaty concentrate for adults and adolescents at PCN sites

Transporting Comirnaty Adult and Adolescent from PCN Designated Sites to end user location

23 December 2020SOP for transporting Comirnaty concentrate for adults and adolescents from PCN sites to end user locations.

Transporting Comirnaty concentrate for Children 5-11 years from PCN Designated Sites to end user location

20 January 2022SOP for transporting Comirnaty concentrate for Children 5-11 years from PCN sites to end user locations.

Preparing Comirnaty Adult and Adolescent Syringes for Administration at end user locations

5 January 2021SOP for preparing Comirnaty concentrate Adult and Adolescent Syringes for administration at end user locations in primary care.

Preparing Comirnaty Children 5-11 years Syringes for Administration at end user locations

21 January 2022SOP for preparing Comirnaty concentrate for Children 5-11 years syringes at end user locations in primary care prior to immediate administration.

Change history

  1. Addition of information regarding Comirnaty (10micrograms/dose) Child 5-11 years throughout. Simplification of storage requirements. Removal of reference to additional doses within vials. All other current content is still accurate.
  1. The current content is still accurate
  1. The current content is still accurate
  1. Amended in line with introduction of licensed Comirnaty product. Link to allergy page mended.
  1. Storage conditions amended to 31 days in the fridge
  1. Published