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

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.

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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.

Standard Operating Procedures for adult and adolescent vaccination

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

Standard Operating Procedures for children's vaccination

Each SOP relevant for use in children 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 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

Training Resources

COVID-19 Vaccine Pfizer-BioNTech pathway critical control points presentation for Trusts

A guidance presentation for process supervisors on COVID-19 Vaccine Pfizer-BioNTech pathway critical control points

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