A SOP is provided for extending the post thaw expiry of Comirnaty (30 microgram/dose) concentrate for Adults and Adolescents at PCN designated sites

Overview

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. The advice specifically refers to vials:

  • which are from the specific batch (lot) numbers listed by Pfizer (see attached SOP for details)
  • that have been stored in accordance with the conditions stated by the manufacturer in the product SPC

This SOP is provided as a unrestricted word document so that it may be adapted for local use. Local professional judgment may be required to assess whether previous storage conditions comply with those stated by the manufacturer. These include:

  • Storage at the correct temperature (2 to 8°C). Vaccines previously subjected to a temperature excursion must not have their expiry dates extended
  • Exposure to light. The vaccine packaging / container must minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Attachments

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