Shelf-life extension for Comirnaty (30 micrograms/dose) concentrate for Adults and Adolescents

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished

Details of shelf-life extension from 9 to 12 months for Comirnaty (30 micrograms/dose) concentrate for Adults and Adolescents.

Shelf life Extension

The MHRA has given permission for the shelf life of Comirnaty 30 micrograms/dose for adults and adolescents to be extended to 12 months when stored at -60°C to -90°C. In addition to this applying to batches manufactured in the future, it can also be retospectively applied to batches already manufactured with a 9 month shelf life.

This extension will have been  applied before you receive the vaccine.

You do not need to take any further action and must not extended the expiry date further.

You should not extend the shelf-life of any Comirnaty® (30 microgram/dose concentrate) you already have in stock

As a result of the shelf-life extension having been applied to frozen vaccines, sites might find that the thawed expiry date at 2°C to 8°C as listed on the carton label is later than the expiry date printed on the vial of vaccine. Please be assured that the vaccine is safe to use until the expiry date on the carton label.

A memo with details of the change will be issued with all stock of Comirnaty (30 micrograms/dose) concentrate for adults and adolescents which is supplied with an extended post thaw expiry.

This applies to all batches of Comirnaty (30 micrograms/dose) concentrate for adults and adolescents.

Vaccine Programme Communication

Attached below is letter issued by the NHS vaccination program which describes the change and how it should be managed.

Also attached is the original dear healthcare professional letter issued by Pfizer which contains details of the expiry extension.

Attachments