Other safety alerts
|
| |
| The United Kingdom: Pfizer／BioNTech COVID-19 vaccine shelf-life extended from 5 to 31 days |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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 been approved.
The Pfizer/BioNTech vaccine, which was the first COVID-19 vaccine to be approved by the United Kingdom 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/government/news/pfizerbiontech-covid-19-vaccine-shelf-life-extended-from-5-to-31-days-says-mhra
In Hong Kong, the above product is not a registered pharmaceutical product under the Pharmacy and Poisons Ordinance (Cap. 138). The COVID-19 vaccine by Fosun Pharma/BioNTech (i.e. Comirnaty) is authorised for emergency use in Hong Kong in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K). Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 26 Feb 2021, with the latest update posted on 20 May 2021. The Department of Health will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Friday, May 21, 2021
Issued at HKT 15:00
|
| |
|
