FDA approves storage of Pfizer COVID-19 vials at regular freezer temperature- Know-how Information, Alenz
Agence France-PresseFeb 26, 2021 12:09:11 IST
Frozen vials of Pfizer’s COVID-19 vaccine could also be saved at temperatures generally present in pharmaceutical freezers for a interval of as much as two weeks, the US Meals and Drug Administration mentioned Thursday. The transfer loosens a earlier requirement that the vaccine must be saved at ultra-low temperatures, between -112 and -76 levels Fahrenheit (-80 to -60 levels Celsius). “The choice temperature for transportation and storage will assist ease the burden of procuring ultra-low chilly storage gear for vaccination websites and may assist to get vaccine to extra websites,” mentioned Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis.
The FDA mentioned it might replace its reality sheet for well being care suppliers accordingly.
Pharmaceutical freezers generally function at round -4 levels Fahrenheit (-20 levels Celsius).
The transfer got here after Pfizer submitted a request based mostly on its analysis on the vaccine’s stability below the hotter temperature.
The Pfizer vaccine is predicated on new know-how that makes use of artificial mRNA (messenger ribonucleic acid) molecules to ship the genetic directions for human cells to create part of the coronavirus.
The mRNA molecules are encased in particles of fats to guard them, however they nonetheless degrade extra rapidly than conventional vaccines and so require stricter storage measures.
As soon as thawed, the vials could be saved at fridge temperatures of 35 to 46 levels Fahrenheit (2 to eight levels Celsius) for as much as 5 days.
They are often stored at room temperature for not more than two hours.
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