Pharmaceutical processes for Comirnaty concentrate for adults and adolescents, and concentrate for children from initial ordering through to administration.

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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 both Comirnaty Children 5-11 years & Adult and Adolescent by PCN Designated Sites

Change history
  1. · Changed throughout to include Children 5-11 years product
  2. · Link to page on dealing with delivery issues restored.
  3. · Link to page on dealing with delivery issues removed as page no longer available
  4. · The current content is still accurate.
  5. · Page updated with link to page on dealing with delivery issues
    1. · SOP suspended and attachment removed from page
    2. · Associated supplies -Updated to reflect current supplies
    3. · Entire document - PCN Clinical Director changed to Lead GP
    4. · Published

Receiving and storing both Comirnaty Children 5-11 years & Adult and Adolescent at PCN Designated Sites

Change history
  1. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  2. · The current content is still accurate.
  3. · 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.
  4. · Reference to less than 120 hours removed.
  5. · Addition of wording to webpage referring to use within Community Pharmacy settings.
    1. · Clarification to who can receive a vaccine supply. Updated to reflect that transport temperature logs are no longer available.
    2. · Published

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

Change history
  1. · PVH3, PVH3.1, PVH3.2 Changed throughout to Adult and Adolescent product. Removal of reference to Regulation 174 product.
  2. · Banner and note on changes in needles added
  3. · PVH3, PVH3.1, PVH3.2 - Amendment to syringe size to allow for changes in supply
  4. · PVH3, PVH3.1, PVH3.2 - Clarification of technique when using a syringe with an auto-retracting needle. Advice added to minimise coring of vial stopper
  5. · The current content is still accurate.
    1. · PVH3.2 - Amended in line with introduction of licensed Comirnaty product
    2. · PVH3 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
    3. · PVH3.1 - 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
    6. · Link to Pfizer video added
    7. · PVH3.2 - Amended in line with updated regulation 174
    8. · PVH3 - Needle gauge options for morbidly obese amended, avoidance of pooling added and amended to six doses in line with updated regulation 174
    9. · PVH3.1 - Amended in line with updated regulation 174
    10. · PVH3 - 5.4.4 - Word “new” added
    11. · PVH3.2 - In line with PVH3 version 2.4 update. Minor clarifications and addition of consumables for sixth dose added into main text
    12. · PVH3 - 5.4.1 - Additional consumables for sixth dose added
    13. · PVH3 - 5.3.1 - Clarification of swab type
    14. · PVH3 - 3 - Wording reflects availability of National Protocol
    15. · PVH3 - 5.1.7 - Clarification of second check
    16. · Published

Stocktaking and reconciliation of both Comirnaty Children 5-11 years & Adult and Adolescent at PCN Designated Sites

Change history
  1. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  2. · The current content is still accurate.
  3. · PVH4 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  4. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  5. · Published

Disposing of both Comirnaty Children 5-11 years & Adult and Adolescent at PCN Designated Sites

Change history
  1. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  2. · The current content is still accurate.
  3. · PVH5 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  4. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  5. · Amendment to details for carton destruction
    1. · Published

Dealing with spillages and breakages of both Comirnaty Children 5-11 years & Adult and Adolescent at PCN Designated Sites

Change history
  1. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  2. · The current content is still accurate.
  3. · PVH6 - Amendment of content and scope to include requirements for use of Regulation 174 and licensed Comirnaty products. Removal of waste code table.
  4. · Addition of wording to webpage referring to use within Community Pharmacy settings.
  5. · Published

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

Change history
  1. · Changed throughout to Adult and Adolescent product. Removal of reference to Regulation 174 product.
  2. · New section on Mutual Aid added. Clarification that returning vials to stock is not normal practice.
  3. · Link to NHSE position statement added to section 4.4
  4. · 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.
  5. · 120 hours changed to 31 days.
    1. · PCN removed from title, clarification box added as terminology has changed. Additional point added that stock cannot be returned to the fridge after transport.
    2. · Addition of wording to webpage referring to use within Community Pharmacy settings.
    3. · Published

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

Change history
  1. · PVH8, PVH8.1, PVH8.2 Changed throughout to Adult and Adolescent product. Removal of reference to Regulation 174 product.
  2. · Text on needle changes added
  3. · Banner on changes in needles added
  4. · PVH8, PVH8.1, PVH8.2 - Amendment to syringe size to allow for changes in supply
  5. · PVH8, PVH8.1, PVH8.2 - Clarification of technique when using a syringe with an auto-retracting needle. Advice added to minimise coring of vial stopper
    1. · The current content is still accurate.
    2. · PVH8.1 - all 5 doses amended to all required doses
    3. · 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.
    4. · PVH8.1 - Amended in line with introduction of licensed Comirnaty product
    5. · PVH8.2 - Amended in line with introduction of licensed Comirnaty product
    6. · PVH8 - Clarification box added as terminology has changed.
    7. · Addition of wording to webpage referring to use within Community Pharmacy settings.
    8. · PVH8 - Clarification following update to national PGD, Clarification of disposal route for outer packaging
    9. · Link to Pfizer video added
    10. · PVH8.1 - Amended in line with updated regulation 174
    11. · PVH8 - Needle gauge options for morbidly obese amended, avoidance of pooling added and amended to six doses in line with updated regulation 174
    12. · PVH8.2 - Amended in line with updated regulation 174
    13. · PVH8.2 - In line with PVH8 version 2.3 update. Minor clarifications and additon of consumables for sixth dose added into main text
    14. · PVH8 - 5.4.1 - Additional consumables for sixth dose added
    15. · PVH8 - 5.4.1 - Additional consumables for sixth dose added
    16. · PVH8 - 5.3.1 - Clarification of swab type
    17. · 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