Shelf-life extension for Comirnaty (10 micrograms/dose) concentrate for Children 5-11 years

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

Details of shelf-life extension from 6 to 9 months for Comirnaty (10 micrograms/dose) concentrate for Children 5-11 years

Shelf life Extension

The MHRA has given permission for the expiry date of three batches (only) of Comirnaty 10 micrograms/dose for children to be extended by three months when stored at -60°C to -90°C. 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® (10 microgram/dose concentrate) you already have in stock

As a result of the 3-month frozen shelf-life extension having been applied, 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 (10 micrograms/dose) concentrate for Children 5-11 years which is supplied with an extended post thaw expiry.

The batches concerned are listed below:

Batch Number Original expiry printed on carton Updated Expiry Date
FN4074 April 2022 July 2022
FN4075 April 2022 July 2022
FP0362 May 2022 August 2022

Vaccine Program 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