Pfizer/BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days, says MHRA

New storage conditions for the Pfizer/BioNTech COVID-19 vaccine, that extend the length of time the thawed vaccine can be stored at normal fridge temperatures from 5 days to 31 days, have today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

The Pfizer/BioNTech vaccine, which was the first COVID-19 vaccine to be approved by the UK regulator, must be stored at ultra-low temperatures until use. The changes, that extend the shelf-life once thawed, are therefore expected to make storage easier and possible for a wider range of health facilities.

The change was approved following the MHRA’s detailed review of additional stability data submitted to the regulator by Pfizer.

Dr June Raine, MHRA Chief Executive, said:

We are pleased to confirm that, having rigorously assessed the additional data submitted to us by the company, we have now approved more flexible storage conditions for the Pfizer/BioNTech vaccine.

Up until now, the Pfizer vaccine had to be administered within 5 days of being removed from ultra-low temperature freezers.

Now that the jab can be stored at normal fridge temperatures for up to 31 days, it can be used in a wider range of healthcare settings, giving patients greater access to the Pfizer vaccine.

Background

See updated Product Information

See our 2 December 2020 press release on the approval of the vaccine

The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The Medicines and Healthcare products Regulatory Agency (‘the agency’) has three centres. The MHRA, the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The agency is an executive agency of the Department of Health and Social Care.

Media enquiries

News centre

MHRA

10 South Colonnade

London

E14 4PU

Email newscentre@mhra.gov.uk

During office hours: 020 3080 7651 (08:30 - 17:00)

Out of office hours: 07770 446 189 (17:00 - 08:30)

Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at