New data indicate the Covid-19 vaccine developed by Pfizer and German partner BioNTech could be stored for two weeks without the ultracold storage currently required, potentially making its use a bit easier.
The companies said Friday they’ve submitted findings from ongoing stability testing to the US Food and Drug Administration, which has authorized the vaccine’s emergency use in the US, and will send the data to regulators around the world in the next few weeks.
The companies want regulators to update temperature requirements to state the vaccines can maintain their potency for two weeks if kept at -13°F to 5°F (-25°C to -15°C), as an additional option.
Freezers and refrigerators used in many pharmacies and hospitals commonly chill to those temperatures — but not to the temperature range
currently authorized, from -112°F to -76°F (-80°C to -60°C). The vaccine can remain stable at those temperatures for up to six months.
That’s why New York-based Pfizer and BioNTech ship the vaccine vials in special thermal containers that can serve as temporary storage for up to 30 days by repeatedly adding dry ice. Still, that can make storing and then thawing and administering the two-dose vaccine challenging in many places, particularly developing countries.
The companies have been testing stability of vaccine batches manufactured at different times over the past nine months and continue to research ways to boost the vaccine’s “shelf life.”
“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer Chief Executive Albert Bourla said in a statement.
The shot is one of just two vaccines that have emergency use authorization in the US, though a third vaccine, created by Johnson & Johnson, is expected to win FDA clearance for emergency use within two weeks.
The other vaccine now authorized in the US, made by Moderna, started out with similarly cold temperature requirements in early-stage studies before stability testing showed it could be stored at normal freezer temps.