Resources covering Pfizer-BioNTech pharmaceutical processes in PCNs, from initial ordering through to administration

Comirnaty brand vaccine · Note that the vaccine is now available in branded and unbranded packs

Comirnaty brand Pfizer-BioNTech vaccine is now available with conditional marketing authorisation. Stocks of regulation 174 vaccine will dwindle concurrently with the licensed product becoming available. Read our article to find out more about the differences and ensure a safe transition.

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Resources underpinning pharmaceutical processes in PCNs for all vaccines
COVID-19 vaccines have different handling and dosing requirements. Sites need to plan to reduce the risk of errors where multiple vaccines are available.

Standard Operating Procedures

Each SOP and a summary of all major changes is provided.

Ordering COVID-19 Vaccine Pfizer-BioNTech by PCN Designated Sites

Change history
  1. · Page updated with link to page on dealing with delivery issues
  2. · SOP suspended and attachment removed from page
  3. · Associated supplies -Updated to reflect current supplies
  4. · Entire document - PCN Clinical Director changed to Lead GP
  5. · Published

Receiving and storing the COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites

Change history
  1. · PVH2 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Addition to clarify wholesaler responsibility regarding transit time greater than 6 hours to delivery.
  2. · Reference to less than 120 hours removed.
  3. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  4. · Clarification to who can receive a vaccine supply. Updated to reflect that transport temperature logs are no longer available.
  5. · Published

Preparing the COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites

Change history
  1. · PVH3 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  2. · PVH3.1 - Amended in line with introduction of licensed Comirnaty product
  3. · PVH3.2 - Amended in line with introduction of licensed Comirnaty product
  4. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  5. · PVH3 - Clarification following update to national PGD, Clarification of disposal route for outer packaging
    1. · Link to Pfizer video added
    2. · PVH3 - Needle gauge options for morbidly obese amended, avoidance of pooling added and amended to six doses in line with updated regulation 174
    3. · PVH3.1 - Amended in line with updated regulation 174
    4. · PVH3.2 - Amended in line with updated regulation 174
    5. · PVH3.2 - In line with PVH3 version 2.4 update. Minor clarifications and addition of consumables for sixth dose added into main text
    6. · PVH3 - 5.4.4 - Word “new” added
    7. · PVH3 - 5.4.1 - Additional consumables for sixth dose added
    8. · PVH3 - 5.3.1 - Clarification of swab type
    9. · PVH3 - 3 - Wording reflects availability of National Protocol
    10. · PVH3 - 5.1.7 - Clarification of second check
    11. · Published

Stocktaking and reconciliation of COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites

Change history
  1. · PVH4 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  2. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  3. · Published

Disposing of damaged, unused or expired COVID-19 Vaccine Pfizer-BioNTech at PCN designated sites

Change history
  1. · PVH5 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  2. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  3. · Amendment to details for carton destruction
  4. · Published

Dealing with spillages and breakages of COVID-19 Vaccine Pfizer-BioNTech at PCN Designated Sites

Change history
  1. · PVH6 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  2. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  3. · Published

Transporting COVID-19 Vaccine Pfizer-BioNTech from Designated Sites to end user location

Change history
  1. · PVH7 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table. Addition to clarify wholesaler responsibility regarding transit time greater than 6 hours to delivery. Addition to include storage in suitably calibrated fridge at end user site. Addition of statement regarding immediate use. New section added on transport of diluted Comirnaty vaccine and associated risks.
  2. · 120 hours changed to 31 days.
  3. · PCN removed from title, clarification box added as terminology has changed. Additional point added that stock cannot be returned to the fridge after transport.
  4. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  5. · Published

Preparing COVID-19 Vaccine Pfizer-BioNTech Syringes for Administration at end user locations

Change history
  1. · PVH8.1 - all 5 doses amended to all required doses
  2. · PVH8.2 - Amended in line with introduction of licensed Comirnaty product
  3. · PVH8.1 - Amended in line with introduction of licensed Comirnaty product
  4. · PVH8 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Addition to include storage in an end user location fridge. Removal of waste code table.
  5. · PVH8 - Clarification box added as terminology has changed.
    1. · Addition of wording to webpage referring to use within Community Pharmacy settings.
    2. · PVH8 - Clarification following update to national PGD, Clarification of disposal route for outer packaging
    3. · Link to Pfizer video added
    4. · PVH8.2 - Amended in line with updated regulation 174
    5. · PVH8 - Needle gauge options for morbidly obese amended, avoidance of pooling added and amended to six doses in line with updated regulation 174
    6. · PVH8.1 - Amended in line with updated regulation 174
    7. · PVH8 - 5.3.1 - Clarification of swab type
    8. · PVH8.2 - In line with PVH8 version 2.3 update. Minor clarifications and additon of consumables for sixth dose added into main text
    9. · PVH8 - 5.4.1 - Additional consumables for sixth dose added
    10. · PVH8 - 5.4.1 - Additional consumables for sixth dose added
    11. · Published

Training resources

COVID-19 Vaccine Pfizer-BioNTech Handling and Preparation Video

A video produced by Pfizer showing the correct handling and preparation of the COVID-19 Vaccine Pfizer-BioNTech

Other COVID-19 vaccines resources