Min menu

Pages

Latest News [LastPost]

Pfizer requires the FDA to approve drugstore storage



Pfizer Inc and BioNTech have asked the US Food and Drug Administration (FDA) to allow the Coronavirus vaccine to be stored for two weeks at temperatures found in regular pharmaceutical freezers, a change that could simplify vaccine distribution.


The two companies said in a statement, according to Bloomberg Agency, that the partners provided new data showing stability when storing the vaccine at -25 to -15 degrees Celsius below zero (-13 degrees Fahrenheit to 5 degrees Fahrenheit), and the current protocol is for storage for up to 6 months in Freezer very cold at temperatures from -80 ° C to -60 ° C below zero and shipping in a special thermal container.


"If approved, this new storage option will give pharmacies and vaccination centers greater flexibility in how to manage their vaccine supplies," said Albert Burla, CEO of Pfizer.


BioNTech CEO Ugur Shaheen said the partners will continue to search for new formulations to facilitate the transport and use of the vaccine.


The necessary cold storage of vaccines using mRNA technology is a complicating factor for vaccination drives, particularly in countries that lack the necessary infrastructure, where vials of Pfizer-BioNTech vaccine are shipped in a specially designed thermal storage container, which can be used as an ultra-cold temporary freezer for up to 30 days if periodically refilled with dry ice.


While the mRNA vaccine from Moderna can be stored at -20 ° C below zero for 6 months and can be stored in refrigerator temperatures for up to 30 days, in contrast the AstraZeneca Plc vaccine - which uses a different technology - can be stored at refrigerator temperatures for a period of time. Up to six months.


Prior to mixing with saline, the Pfizer-BioNTech vaccine may also be cooled for up to five days at 2 ° C to 8 ° C, and the vaccine is administered at room temperature.


The partners said they will be providing the data to other regulators as well in the coming weeks.

reaction:
Tucson Company Inc
Tucson Company Inc
Tucson Company Inc It is one of the best Egyptian companies specialized in the field of creating and developing Android applications and games, selling them to others, and publishing them through all the services of publishing free and paid applications and games

Comments