Introduction

From time to time, the MHRA may approve batch specific variations to the Marketing Authorisation of COVID-19 vaccines, meaning that some batches may have shelf lives that are different from labelled manufacturer’s expiry date.

Expiry amendments will have been applied to the vaccine cartons by the Specialist Pharmaceutical Logistics (SPL) providers before receipt by vaccination sites.

Following the issue of an expiry extension by a manufacturer, the National Vaccination Programme in England will decide if and when the extension will be applied to existing stocks. Only the extensions approved for implementation by the National Vaccination Programme will appear on this web page.

Comirnaty Original/Omicron BA.4-5

The MHRA has given permission for the shelf life of Comirnaty Original/Omicron BA.4-5 to be extended to 24 months when stored at -60°C to -90°C.

In addition to this applying to batches manufactured in the future, it can also be retrospectively applied to batches already manufactured with a 12 or 18 month shelf life.

This extension will have been applied by the Specialist Pharmaceutical Logistics (SPL) providers before you receive the vaccine.

No further action required

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

You should not extend the shelf-life of any Comirnaty Original/Omicron BA.4-5 you already have in stock.

Expiry date differences

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 thaw 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 thaw label as applied to the carton by the SPLs.

Further information

To support the start of the Autumn/Winter 2023/24 campaign, sites will not receive a reminder communication about the shelf life extension with each Comirnaty BA.4-5 delivery for a temporary period

This applies to all batches of Comirnaty Original/Omicron BA.4-5.

The direct healthcare professional communication issued by Pfizer is available on NHS Futures (log-in required) and contains details of the expiry extension.

Update history