Pharmaceutical processes for Comirnaty (30 micrograms/dose) for Adults and Adolescents, from initial ordering through to administration for PCNs and Trusts.

Comirnaty Children's Vaccine · Understanding differences and risks following its introduction

Our Pfizer-BioNTech standard operating procedures are now organised by both vaccination site location and vaccine type, to help with the introduction of Comirnaty (10 micrograms/dose) concentrate for Children 5 to 11 years. Read our article for a summary of the differences and risks to manage.

Read first for PCNs

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.

SOPs for PCNs

Each SOP relevant for adult and adolescent use in PCNs and a summary of all major changes is provided

Ordering both Comirnaty concentrate vaccines by PCN Designated Sites

Change history
  1. · Modified to described a pull model.
  2. · Changed throughout to include Children 5-11 years product
  3. · Link to page on dealing with delivery issues restored.
  4. · Link to page on dealing with delivery issues removed as page no longer available
  5. · The current content is still accurate.
    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 both Comirnaty concentrate vaccines 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

Extending the post thaw expiry of Comirnaty (30 microgram/dose) concentrate for Adults and Adolescents at PCN designated sites

Change history
  1. · Post thaw expiry extension no longer supported. SOP withdrawn
  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. · PVH3.1 - 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. · PVH3.2 - 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
    6. · Link to Pfizer video added
    7. · PVH3.1 - 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. · PVH3.2 - Amended in line with updated regulation 174
    10. · PVH3 - 5.1.7 - Clarification of second check
    11. · PVH3 - 3 - Wording reflects availability of National Protocol
    12. · PVH3 - 5.3.1 - Clarification of swab type
    13. · PVH3 - 5.4.1 - Additional consumables for sixth dose added
    14. · PVH3.2 - In line with PVH3 version 2.4 update. Minor clarifications and addition of consumables for sixth dose added into main text
    15. · PVH3 - 5.4.4 - Word “new” added
    16. · Published

Stocktaking and reconciliation of both Comirnaty Concentrate Vaccines 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 Concentrate Vaccines 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 concentrate vaccines 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. · Clarification of wording in section 4.3.4
  2. · Changed throughout to Adult and Adolescent product. Removal of reference to Regulation 174 product.
  3. · New section on Mutual Aid added. Clarification that returning vials to stock is not normal practice.
  4. · Link to NHSE position statement added to section 4.4
  5. · 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.
    1. · 120 hours changed to 31 days.
    2. · PCN removed from title, clarification box added as terminology has changed. Additional point added that stock cannot be returned to the fridge after transport.
    3. · Addition of wording to webpage referring to use within Community Pharmacy settings.
    4. · 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. · PVH8.2 - Amended in line with introduction of licensed Comirnaty product
    4. · PVH8.1 - Amended in line with introduction of licensed Comirnaty product
    5. · 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.
    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. · PVH8.2 - 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. · PVH8.1 - Amended in line with updated regulation 174
    13. · PVH8 - 5.3.1 - Clarification of swab type
    14. · PVH8 - 5.4.1 - Additional consumables for sixth dose added
    15. · PVH8 - 5.4.1 - Additional consumables for sixth dose added
    16. · PVH8.2 - In line with PVH8 version 2.3 update. Minor clarifications and additon of consumables for sixth dose added into main text
    17. · Published

Read first for Trusts

Resources underpinning pharmaceutical processes in Trusts and Vaccination Centres for all vaccines
Must read guidance for Chief Pharmacists and others in Trusts on the COVID-19 Vaccine Pfizer-BioNTech.
COVID-19 vaccines have different handling and dosing requirements. Sites need to plan to reduce the risk of errors where multiple vaccines are available.

SOPs for Trusts

Each SOP relevant for adult and adolescent use in Trusts and a summary of all major changes is provided

Ordering both Comirnaty concentrate vaccines

Change history
  1. · All Comirnaty vaccines now ordered using foundry system
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Page title changed from Ordering COVID-19 Vaccine Pfizer-BioNTech from UK Health Security Agency Public Health England (PHE) for Trusts to Ordering COVID-19 Vaccine Pfizer-BioNTech from UK Health Security Agency (UKHSA - formerly known as PHE) for Trusts
  5. · All updated to reflect availability of Comirnaty-branded product and associated changes to handling
    1. · Detail on local ordering system removed and link to NHS England SOP on ordering added.
    2. · Published

Receiving of thawed Comirnaty concentrate for adults in Trusts

Change history
  1. · Added requirement to document time in transit
  2. · Published

Receiving of frozen Comirnaty concentrate for adults and adolescents in ultra-low temperature freezers in Trusts

Change history
  1. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Updated to reflect availability of Comirnaty-branded product and associated changes
  5. · Published

Unpacking and storing frozen Comirnaty concentrate for adults and adolescents in ultra-low temperature freezers in Trusts

Change history
  1. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Updated to reflect availability of Comirnaty-branded product and associated changes
  5. · Published

Unpacking of frozen Comirnaty concentrate for adults and adolescents and transfer to fridges to thaw in Trusts without freezers

Change history
  1. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Updated to reflect availability of Comirnaty-branded products and associated changes
  5. · New Pfizer thaw label image added
    1. · Post thaw refrigerated expiry extended to 31 days
    2. · Title slightly amended to "Unpacking of frozen Pfizer-BioNTech COVID-19 vaccine and transfer to fridges to thaw in Trusts without freezers"
    3. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
    4. · Published

Moving Comirnaty concentrate for adults and adolescents from an ULT freezer into a fridge to thaw in Trusts

Change history
  1. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Correction of 'movement from shipper' to 'movement from ULT'
  5. · Updated to reflect availability of Comirnaty-branded product and associated changes
    1. · New Pfizer thaw label image added
    2. · Post thaw refrigerated expiry extended to 31 days
    3. · Published

Thawing small numbers of vials of Comirnaty concentrate for adults and adolescents

Change history
  1. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Updated to reflect availability of Comirnaty-branded product and associated changes
  5. · New Pfizer thaw label image added with extended 31 day expiry
    1. · Published

Cryocube F101-h Freezer Temperature Monitoring and Recording in Trusts

Change history
  1. · Reference to Comirnaty (10 microgram/dose) concentrate for Children 5-11 years removed as this presentation no longer to be delivered frozen
  2. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  3. · Content reviewed and accurate
  4. · Updated to reflect storage conditions as stated for Comirnaty branded product
  5. · Published

Extending the post thaw expiry of Comirnaty (30 microgram/dose) concentrate for Adults and Adolescents in Trusts

Change history
  1. · Post thaw expiry extension no longer supported. SOP withdrawn
  2. · Published

Preparing Comirnaty adults and adolescents syringes in Trusts

Change history
  1. · Changed throughout to include Children 5-11 years product. Removal of reference to Regulation 174 product.
  2. · Text added on changes to needles
  3. · Banner added on changes to needles
  4. · Additional detail on need to undertake gradual pressure equalisation if using an auto retracting needle. Additional detail on technique to reduce coring. Use of 2mL or 3mL syringe for dilution added to reflect new syringes supplied
  5. · Updated to reflect availability of Comirnaty & associated changes
    1. · VH8 Amended instructions for disposal of cartons to include placing in confidential waste
    2. · VH8, VH8.1 and VH8.2 updated to describe withdrawal of 6 doses as standard practice
    3. · VH8 Section 2 updated to include model of one person diluting and drawing up
    4. · VH8 4.4.4 Now states “new” syringe / needle must be used
    5. · VH8 4.4.1, VH8.1 and VH8.2 updated to include additional references to 6th dose
    6. · VH8 4.1.7 addition of 2nd check to include correct vaccine vial selected
    7. · Change to SOP VH8 Section 4.3.4, regarding presence of opaque particles prior to dilution
    8. · VH8.1 updated to reflect the change
    9. · Published