Pharmaceutical processes for Comirnaty (10 micrograms/dose) for Children 5 to 11 years, 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 use in children 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

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

Change history
  1. · Images added to identify post thaw expiry and original ULT expiry on vaccine packaging.
  2. · 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 concentrate for Children 5-11 years from PCN Designated Sites to end user location

Change history
  1. · Section 4.4 rewritten to reflect SmPC change which allows movement of the diluted product
  2. · Clarification of wording in section 4.3.2
  3. · Images added to identify post thaw expiry and original ULT expiry on vaccine packaging.
  4. · Published

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

  1. · Published · This article has not changed since

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 use in children in PCNs 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 children 5-11 years in Trusts

Change history
  1. · First Published
  2. · Published

Preparing Comirnaty for Children 5-11 years in Trusts

Change history
  1. · point 4.1.4 Images added to identify post thaw expiry and original ULT expiry on vaccine packaging.
  2. · SOP document references amended from VH to CVH. Document content remains unchanged
  3. · First Issue
  4. · Published