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

Change approved following detailed review of additional stability data

Vaccine vials

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 MHRA바카라 사이트™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 (바카라 사이트˜the agency바카라 사이트™) has three centres. The MHRA, the and the . The agency is an executive agency of the Department of Health and Social Care.

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Published 20 May 2021