Pfizer asks FDA to approve storage of doses at higher temperatures

A photograph taken on January 15, 2021 shows a pharmacist holding in gloved hands a vial of undiluted Pfizer-BioNTech vaccine for Covid-19, stored at -70 ° in a super freezer at Le Mans hospital in the northwest France as a country carries out a vaccination campaign to fight against the spread of the new coronavirus.

Jean-Francois Monier | AFP | fake images

Pfizer said Friday that it is 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 drugmaker BioNTech, currently must be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA. Pfizer said it submitted new data to the US agency showing the vaccine is stable at minus 13 to 5 degrees Fahrenheit.

If the FDA accepts the request, it could simplify the logistics for vaccine distribution. Federal and state officials are trying to accelerate the pace of vaccines across the country as the virus spreads.

“We have been continuously conducting stability studies to support commercial-scale production of the vaccine, with the goal of making the vaccine as accessible as possible to healthcare providers and people in the US and throughout the world. the world, “said Pfizer CEO Albert Bourla 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 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 quarantined several thousand doses in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to get 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 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.

By comparison, Moderna’s vaccine should ship between minus 13 and 5 degrees Fahrenheit. You’ve said your vaccine is stable between 36 and 46 degrees Fahrenheit, the temperature of a standard household or medical refrigerator, for up to 30 days. It can be stored for six months at minus 4 degrees Fahrenheit.

Johnson & Johnson’s vaccine, which the FDA is expected to clear for emergency use earlier this month, has said it plans to ship its vaccine at a temperature of 36 to 46 degrees Fahrenheit.

As additional stability data becomes available, Pfizer said it anticipates shelf life could be extended and alternative short-term temperature storage could be considered.


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