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

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished Last updated See all updates
Topics: AdultsCold chain managementPfizer-BioNTech: Handling · Standard Operating ProceduresTrusts ·

A standard operating procedure for unpacking frozen of Comirnaty vaccines and transferring them to fridges to thaw is provided.

Purpose

The attached standard operating procedure describes the process of unpacking frozen Comirnaty concentrate for adults and adolescents and transfer to a fridge to thaw.

Expiry Extension

In January 2022, Pfizer permitted certain thawed batches of Comirnaty (30microgram/dose) concentrate for Adults and Adolescents to have their post-thaw expiry dates extended from 31 to 45 days. This permission is no longer applicable and so the SPS standard operating procedure supporting the process has been withdrawn.

All Comirnaty (30microgram/dose) concentrate for Adults and Adolescents is supplied from the NHS’s logistics partners is already labelled with a 31-day post-thaw expiry date. No extensions may be applied.

Presentation

The attachment is presented in Word to enable adaptation locally, or as reference source to check that existing local procedures are robust and comprehensive.
Within the SOP:

  • GREEN TEXT indicates that detail is awaited, and will be added when available;
  • RED TEXT indicates where detail is to be added locally.

Attachments

Other handling content for Trusts

Other COVID-19 vaccines resources

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