Pfizer Asks FDA to Approve Storage of Vaccine in Customary Freezers

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Pfizer and BioNTech have submitted knowledge to the US Meals and Drug Administration (FDA) demonstrating that their COVID-19 vaccine will be safely saved at temperatures generally present in pharmaceutical freezers and fridges.

The info present that the vaccine is secure when saved at -25° C to -15° C (-13° F to five° F), the 2 corporations stated in a press release. Vaccines are sometimes saved at these temperatures, in keeping with the Facilities for Illness Management and Prevention (CDC).

Pfizer Chairman and CEO Albert Bourla stated the 2 corporations had been constantly exploring the way to produce a vaccine that might be extra accessible to a wide range of administration websites. The FDA will evaluate the info and decide whether or not the Pfizer/BioNTech vaccine label will be modified. At present, the label states that the vaccine should be saved at temperatures from -80° C to -60° C (-112° F to -76° F).

The businesses are in search of to alter the label to permit an choice to retailer the vaccine for two weeks at -25° C to -15° C (-13° F to five° F). The Moderna vaccine, which is the one different COVID-19 vaccine with an FDA emergency use authorization, is shipped and saved at these temperatures, in keeping with the CDC.

“If authorized, this new storage possibility would provide pharmacies and vaccination facilities better flexibility in how they handle their vaccine provide,” stated Bourla within the assertion.

As of now, the Pfizer/BioNTech vaccine should be shipped in particular containers that must be repacked with dry ice each 5 days if the container will probably be used as a main storage unit. That unit can solely be used for as much as 30 days. The vaccine can in any other case be saved on the ultracold temperatures for as much as 6 months.

At present, the Pfizer/BioNTech vaccine additionally will be saved in an ordinary fridge (from 2° C to eight° C) for as much as 5 days, after which it may be administered at room temperature.

Though it is harder to ship and retailer the Pfizer vaccine, it has been administered to extra Individuals, partly as a result of it was the primary to obtain emergency authorization.

In line with the CDC’s COVID Information Tracker, 29.5 million Pfizer/BioNTech vaccines have been administered, and 28 million Moderna vaccines have been given.

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