Pfizer is asking the FDA to approve the storage of cans at larger 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 said Friday it was applying for permission from the Food and Drug Administration to store its Covid-19 vaccine for two weeks at temperatures typically found in pharmaceutical freezers and refrigerators.
The vaccine, which was developed with the German drug manufacturer BioNTech, currently has to be stored in ultra-cold freezers, which keep it between minus 112 and minus 76 degrees Fahrenheit, according to the FDA. Pfizer told the US agency that the vaccine was stable between minus 13 and 5 degrees Fahrenheit.
If the FDA approves the application, it could simplify the logistics of getting the vaccine out. Federal and state officials are trying to speed up the pace of vaccinations across the country as the virus spreads.
“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 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 cans 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.
For comparison: Moderna’s vaccine has to be shipped between minus 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 six months.
Johnson & Johnson’s vaccine, expected to receive FDA emergency approval as early as this month, is slated to deliver 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.