A photo taken on January 15, 2021 shows a pharmacist with gloved hands holding an ampoule of the undiluted Pfizer-BioNTech vaccine for Covid-19, stored at -70 ° in a super freezer at the hospital of Le Mans, northwestern France as the country are conducting a vaccination campaign to combat the spread of the new coronavirus.
Jean-Francois Monier | AFP | Getty Images
Pfizer said Friday 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 drug manufacturer BioNTech, currently has to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, the FDA said. Pfizer said it has submitted new data to the U.S. agency showing the vaccine is stable between minus 13 and 5 degrees Fahrenheit.
If the FDA grants the request, it can simplify logistics for vaccine distribution. Federal and state officials are trying to ramp up the pace of vaccinations across the country as the virus spreads.
“We have continuously conducted stability studies to support commercial-scale production of the vaccine, with the goal of making the vaccine as accessible as possible to healthcare professionals and people in the US and around the world,” Pfizer CEO Albert Bourla said in a statement. release. “If approved, this new storage option would give pharmacies and vaccination centers more flexibility in managing their vaccine stock.”
Medical experts had warned that Pfizer’s vaccine would pose 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 shipping process caused storage temperatures to drop too low.
The vaccine is shipped in a special thermal container that can be used as temporary storage for up to 30 days by refilling with dry ice every five days. Before being mixed with saline, the vaccine can also be refrigerated for up to five days at a standard refrigerator temperature, between 36 degrees and 46 degrees Fahrenheit, the company said.
In comparison, Moderna’s vaccine should ship between minus 13 and 5 degrees Fahrenheit. It has said the vaccine will remain stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medicine refrigerator. It can be stored at minus 4 degrees Fahrenheit for six months.
The Johnson & Johnson vaccine, which is expected to be approved by the FDA for emergency use as early as this month, has said it plans to ship the vaccine at 36 to 46 degrees Fahrenheit.
As additional stability data is obtained, Pfizer said it expects shelf life to be extended and alternative storage to be considered in the short term.