A photo taken on January 15, 2021 shows a pharmacist holding an undiluted Pfizer-BioNTech vaccine for Covid-19 in gloved hands, stored at -70 ° in a super freezer at Le Mans hospital, northwest France as the country has a vaccination campaign to fight the spread of the new coronavirus.
Jean-Francois Monier | AFP | Getty Images
Pfizer said on 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 freezers and pharmaceutical refrigerators.
The vaccine, which was developed with the German pharmaceutical company BioNTech, currently needs to be stored in deep-frozen freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA. Pfizer said it has sent new data to the U.S. agency showing that the vaccine is stable between minus 13 and 5 degrees Fahrenheit.
If the FDA complies with the request, it can simplify the vaccine distribution logistics. Federal and state officials are trying to speed up the pace of vaccinations across the country, as the virus spreads.
“We have been conducting stability studies on an ongoing basis to support vaccine production on a commercial scale, with the goal of making the vaccine as accessible as possible to healthcare professionals and people in the United States and around the world,” said Pfizer CEO Albert Bourla, at a launch. “If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in the way they administer the supply of the vaccine.”
Medical experts warned that the Pfizer vaccine would present logistical challenges due to the need for ultracold temperatures. In December, American officials said they quarantined several thousand doses in California and Alabama after an “anomaly” in the transport process caused the storage temperature to be very low.
The vaccine is shipped in a special thermal container that can be used as temporary storage for up to 30 days, replenishing with dry ice every five days. Before mixing with a saline diluent, the vaccine can also be refrigerated for up to five days at the standard refrigerator temperature, between 36 degrees and 46 degrees Fahrenheit, according to the company.
In comparison, Moderna’s vaccine needs to be shipped between minus 13 and 5 degrees Fahrenheit. She said her vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a home or medical refrigerator, for up to 30 days. It can be stored for six months at minus 4 degrees Fahrenheit.
The Johnson & Johnson vaccine, which should be authorized for emergency use by the FDA earlier this month, said it plans to ship its vaccine at 36 to 46 degrees Fahrenheit.
As additional stability data is obtained, Pfizer said it anticipates that the shelf life may be extended, and alternative storage at short-term temperature can be considered.