FDA Approves Storage Of Pfizer COVID-19 Vaccine At Standard Freezing Temperature
The Food and Drug Administration (FDA) announced Thursday that Pfizer-BioNTech’s COVID-19 vaccine could be stored at conventional freezing temperatures instead of only at ultra-cold temperature, potentially easing storage requirements at pharmacies and medical centers.
Pfizer’s vaccine initially needed to be shipped in specifically designed units that could reach temperatures between -112ºF to -76ºF after it was approved for emergency use in December. The undiluted vaccine vials will now be able to be transported and stored at conventional temperatures after Pfizer submitted data supporting the alternative storage temperatures, according to the FDA.
“This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.
“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites.”
Pfizer’s data showed that the vaccine remains stable for up to two weeks at standard freezing temperature.
Power outages across the country caused by severe winter weather raised concerns about vaccine storage due to blackouts that affected freezers. (RELATED: Risk Of COVID-19 Vaccine Spoilage Increases Because Of Power Outages, Severe Weather)
Although there have been delays, a third vaccine could accelerate vaccine distribution in the U.S. Johnson & Johnson’s single dose vaccine will be reviewed by an FDA advisory committee Friday after the FDA determined the vaccine was safe and effective against the coronavirus earlier in the week.
More than 45 million Americans have been vaccinated as of Thursday, but fewer than 21 million have received both doses, according to Business Insider. Pfizer and Moderna have pledged to distribute 600 million doses to the U.S. by the end of July, and Johnson & Johnson has said it could deliver up to 100 million doses by the end of June.