Pfizer asks FDA to approve storing Covid vaccine doses at higher temperatures

An image taken on January 15, 2021, exhibits a pharmacist holding with gloved palms a phial of the undiluted Pfizer-BioNTech vaccine for Covid-19, saved at -70 ° in a brilliant freezer of the hospital of Le Mans, northwestern France because the nation keep it up a vaccination marketing campaign to struggle towards the unfold of the novel coronavirus.

Jean-Francois Monier | AFP | Getty Images

Pfizer mentioned Friday it’s looking for permission from the Food 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, at the moment wants to be saved in ultra-cold freezers that maintain it between minus 112 and minus 76 levels Fahrenheit, in accordance to the FDA. Pfizer mentioned it submitted new information 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 try to decide up the tempo of vaccinations throughout the nation because the virus spreads.

“We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,” Pfizer CEO Albert Bourla mentioned in a launch. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.”

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

The vaccine is shipped in a particular thermal container that can be utilized as non permanent storage for up to 30 days by refilling with dry ice each 5 days. Before mixing with a saline diluent, the vaccine may additionally be refrigerated for up to 5 days at commonplace fridge temperature, between 36 levels and 46 levels Fahrenheit, in accordance to the corporate.

By comparability, Moderna’s vaccine wants to be shipped at between minus 13 and 5 levels Fahrenheit. It has mentioned its vaccine stays secure at 36 to 46 levels Fahrenheit, the temperature of a typical house or medical fridge, for up to 30 days. It may be saved for six months at minus four levels Fahrenheit. 

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

As further stability information is obtained, Pfizer mentioned it anticipates the shelf life might be prolonged, and alternate short-term temperature storage could also be thought of.

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