Pfizer Inc. and BioNTech SE asked the US Meals and Drug Administration to enable their Covid-19 vaccine to be stored for two months at temperatures discovered in regular pharmaceutical freezers, a alter that could simplify distribution for the shot.
The companions submitted new information showing balance when the vaccine is stored at minus twenty five-to-minus 15 degrees Celsius (-13°F to 5°F), they stated in a statement on Friday. Latest protocol is for storage for up to six months in an extremely-chilly freezer at temperatures of -80ºC to -60ºC and shipping and delivery in a exclusive thermal container.
“If authorised, this new storage alternative would give pharmacies and vaccination facilities greater overall flexibility in how they deal with their vaccine offer,” Pfizer Main Executive Officer Albert Bourla stated in a statement. The companions will hold hunting for new formulations to make the vaccine a lot easier to transportation and use, BioNTech CEO Ugur Sahin stated.
The chilly storage needed for messenger RNA vaccines is one particular complicating element for vaccine rollout, notably in nations with no the needed infrastructure. Vials of the Pfizer-BioNTech vaccine are delivered in a specifically-developed thermal container, which if refilled periodically with dry ice, can be applied as a makeshift extremely-chilly freezer for as numerous as 30 times.
Vials of the Pfizer-BioNTech vaccine are delivered in a specifically-developed thermal container, which maintains a temperature vary of -90ºC to -60ºC and — if refilled periodically with dry ice — can be applied as a makeshift extremely-chilly freezer for as numerous as 30 times.
Just before mixing with a saline diluent, the vaccine may well also be refrigerated for up to five times at 2⁰C to 8⁰C. The vaccine is administered at area temperature.
The companions stated they will file the information to other regulators as very well in coming months.