A photo taken on January 15, 2021, shows a pharmacist holding in his gloves a bottle of the Pfizer-BioNTech undiluted vaccine for Covid-19, stored at -70 ° in a freezer of the hospital in Le Mans, northwestern France, as The country is conducting a vaccination campaign to fight 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 keep its Covid-19 vaccine for two weeks at temperatures commonly found in pharmaceutical freezers and refrigerators.
The vaccine, which was developed in conjunction with German doctor BioNTech, must now be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA. Pfizer said it had sent new data to the US agency showing that the vaccine is stable between minus 13 and 5 degrees Fahrenheit.
If the FDA accepts the request, it could simplify the logistics for distributing the vaccine. Federal and state officials are trying to pick up vaccinations across the country as the virus spreads.
“We have continuously conducted stability studies to support commercial-scale vaccine production in order to make the vaccine as accessible as possible to health care providers and people in the United States and around the world,” said Albert Bourla, CEO. to Pfizer. a release. “If approved, this new storage option would give pharmacies and vaccination centers more flexibility in how they manage their vaccine supply.”
Medical experts have warned that the Pfizer vaccine will 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 caused the storage temperature to cool too much.
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 mixing with a saline diluent, the vaccine can also be refrigerated for up to five days at the standard refrigerator temperature, between 36 and 46 degrees Fahrenheit, according to the company.
By comparison, the Moderna vaccine should be transported 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 up to 30 days. It can be kept for six months at minus 4 degrees Fahrenheit.
The Johnson & Johnson vaccine, which is expected to be authorized for emergency use by the FDA as early as this month, said it intends to deliver its vaccine at 36 to 46 degrees Fahrenheit.
As additional stability data is obtained, Pfizer said it anticipates that the shelf life could be extended and alternative short-term temperature storage could be considered.