Pfizer asks FDA to approve storing doses at higher temperatures

Pfizer stated Friday it’s in search of permission from the Meals and Drug Administration to retailer its Covid-19 vaccine for 2 weeks at temperatures generally present in pharmaceutical freezers and fridges.

The vaccine, which was developed with German drugmaker BioNTech, presently must be saved in ultra-cold freezers that maintain it between minus 112 and minus 76 levels Fahrenheit, in accordance with the FDA. Pfizer stated it submitted new knowledge to the U.S. company that exhibits the vaccine is secure between minus 13 and 5 levels Fahrenheit.

If the FDA grants the request, it may simplify logistics for distribution of the vaccine. Federal and state officers are attempting to select up the tempo of vaccinations throughout the nation because the virus spreads.

“Now we have been repeatedly performing stability research to assist the manufacturing of the vaccine at business scale, with the objective of creating the vaccine as accessible as potential for healthcare suppliers and folks throughout the U.S. and all over the world,” Pfizer CEO Albert Bourla stated in a launch. “If authorized, this new storage possibility would supply pharmacies and vaccination facilities larger flexibility in how they handle their vaccine provide.”

Medical consultants had warned that Pfizer’s vaccine would current logistical challenges due to the necessity for ultracold temperatures. In December, U.S. officers stated they quarantined a number of thousand doses in California and Alabama after an “anomaly” within the transportation course of induced the storage temperature to get too chilly.

The vaccine is shipped in a particular thermal container that can be utilized as short-term storage for as much as 30 days by refilling with dry ice each 5 days. Earlier than mixing with a saline diluent, the vaccine might also be refrigerated for as much as 5 days at commonplace fridge temperature, between 36 levels and 46 levels Fahrenheit, in accordance with the corporate.

By comparability, Moderna’s vaccine must be shipped at between minus 13 and 5 levels Fahrenheit. It has stated its vaccine stays secure at 36 to 46 levels Fahrenheit, the temperature of a typical dwelling or medical fridge, for as much as 30 days. It may be saved for six months at minus 4 levels Fahrenheit. 

Johnson & Johnson’s vaccine, which is predicted to be licensed for emergency use by the FDA as early as this month, has stated it plans to ship its vaccine at 36 to 46 levels Fahrenheit.

As further stability knowledge is obtained, Pfizer stated it anticipates the shelf life could possibly be prolonged, and alternate short-term temperature storage could also be thought-about.