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

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

Following advice issued by Pfizer and the MHRA on 14 January 2022, the post thaw expiry date of specific batch numbers of Comirnaty (30microgram/dose) concentrate for Adults and Adolescents may be extended by 14 days. i.e. to a maximum of 45 days from the date of removal from -70°C storage see our SPS example procedure for expiry extension

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