Pfizer asks FDA to approve storing doses at greater temperatures

A picture taken on January 15, 2021 shows a pharmacist holding a vial of undiluted Pfizer BioNTech vaccine for Covid-19 with gloved hands, which is stored at -70 ° in a super freezer at Le Mans hospital in northwestern France became country runs a vaccination campaign to fight the spread of the novel coronavirus.

Jean-Francois Monier | AFP | Getty Images

Pfizer is asking the Food and Drug Administration for permission to store its Covid-19 vaccine for two weeks at temperatures typically found in pharmaceutical freezers and refrigerators, the US drug maker said on Friday.

The vaccine, which was developed with the German drug manufacturer BioNTech, currently has to be stored in ultra-cold freezers, which, according to the FDA, are between minus 112 and minus 76 degrees Fahrenheit. Pfizer said it presented new data to the U.S. agency showing the vaccine is stable between negative 13 and 5 degrees Fahrenheit.

If the FDA grants the OK, it could simplify the logistics for distributing the vaccine in the US. Federal and state officials are trying to speed up the pace of vaccinations across the country as the virus continues to spread.

“We have continuously conducted stability studies to support the manufacture of the vaccine on a commercial scale with the aim of making the vaccine as accessible as possible to healthcare providers and people in the US and around the world,” said Albert Bourla, CEO of Pfizer a publication. “If approved, this new storage option would offer pharmacies and vaccination centers more flexibility in managing their vaccine supplies.”

Medical experts had previously warned that Pfizer’s vaccine would pose a new logistical challenge as it would have to be stored in ultra-cold temperatures. In December, US officials said they quarantined several thousand doses of the vaccine in California and Alabama after an “anomaly” in the transportation process caused the storage temperature to become too cold.

The vaccine comes in a special warming container that can be used as a temporary storage facility for up to 30 days, with dry ice refilled every five days. The vaccine can also be refrigerated for up to five days at a standard refrigerator temperature of between 36 and 46 degrees Fahrenheit, according to the company, before mixing it with a salt diluent.

In comparison, Moderna’s vaccine has to be delivered between 13 and 5 degrees Fahrenheit. It has said its vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a regular household or medical refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months.

Johnson & Johnson’s Covid vaccine, expected to receive FDA emergency approval as early as this month, plans to ship its vaccine at 36 to 46 degrees Fahrenheit.

As additional stability data will be obtained, Pfizer believes that shelf life could be extended and alternative short term temperature storage could be considered.