Pfizer asks FDA to approve storage of doses at higher temperatures

Pfizer said on Friday it was seeking permission from the Food and Drug Administration to store its Covid-19 vaccine for two weeks at temperatures commonly found in pharmaceutical freezers and refrigerators.

The vaccine, which was developed with German drug maker BioNTech, currently needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA. Pfizer said it has submitted new data to the U.S. agency which shows the vaccine is stable between minus 13 and 5 degrees Fahrenheit.

If the FDA accepts the request, it could simplify the logistics of distributing the vaccine. Federal and state officials are trying to speed up the pace of vaccinations across the country as the virus spreads.

“We are continually conducting stability studies to support production of the vaccine on a commercial scale, with the goal of making the vaccine as accessible as possible to healthcare providers and people in the United States and around the world.” , said Albert Bourla, CEO of Pfizer, in an outing. “If approved, this new storage option would provide pharmacies and immunization centers with greater flexibility in managing their vaccine supply.”

Medical experts had warned that Pfizer’s vaccine would present logistical challenges due to the need for ultra-cold temperatures. In December, US officials said they had quarantined several thousand doses in California and Alabama after an “anomaly” in the transportation process made the storage temperature too cold.

The vaccine is shipped in a special thermal container that can be used as temporary storage for up to 30 days by filling with dry ice every five days. Before mixing it with a saline diluent, the vaccine can also be refrigerated for up to five days at standard refrigerator temperature, between 36 degrees and 46 degrees Fahrenheit, according to the company.

In comparison, Moderna’s vaccine must be shipped between minus 13 and 5 degrees Fahrenheit. He said his vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for 30 days. It can be stored for six months at minus 4 degrees Fahrenheit.

Johnson & Johnson’s vaccine, which is expected to be cleared for emergency use by the FDA as early as this month, has announced plans to ship its vaccine between 36 and 46 degrees Fahrenheit.

As more stability data is obtained, Pfizer said it anticipates that shelf life may be extended and that alternative short-term storage may be considered.