Other safety alerts
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| The United States: FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 Vaccine |
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The US Food and Drug Administration (FDA) announces that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.
Pfizer submitted data to the FDA to demonstrate that its COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature. The alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution (which can be held in the refrigerator for up to 5 days), or on the storage of thawed vials after dilution (which can be held at refrigerator temperature or room temperature for use within 6 hours).
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer
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). The Department of Health will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Friday, Feb 26, 2021
Issued at HKT 15:00
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