In some good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions and can be stored stably for two weeks at standard freezing temperatures.
The companies have submitted data to the U.S. Food and Drug Administration demonstrating stability at warmer temperatures in a bid to gain regulatory approval to relax storage requirements and labeling for the vaccine.
If the FDA gives the green light for the change, warmer storage conditions could dramatically facilitate vaccine distribution, allowing doses to be sent to non-specialized vaccine delivery sites. The change would also make it much easier to distribute the vaccine to low-income countries.
“We have continued to conduct stability studies to support the production of the vaccine on a commercial scale, with the goal of making the vaccine as accessible as possible to healthcare providers and people in the US and around the world,” Pfizer CEO Albert Bourla said in a statement. . “If approved, this new storage option would provide pharmacies and vaccination centers with greater flexibility in managing their vaccine stock.”
Currently, the vaccine is labeled to be stored for up to six months between -80°C and -60°C (-112°F to -76°F). But it can also be refrigerated for up to five days at standard refrigerator temperatures (2⁰C and 8⁰C (36⁰F and 46⁰F)). The ultra-cold demand cooled enthusiasm for the vaccine when the FDA first granted it emergency approval for use. Only specialized facilities, such as hospitals and research labs, tend to have freezers equipped to maintain such cold temperatures, raising concerns about how easy it would be to get the vaccine into people’s arms.
Prior to the vaccine rollout, Pfizer and BioNTech sought to address those concerns, focusing on their expertise and existing cold chain infrastructure. The two companies developed specially designed, temperature-controlled thermal shippers filled with dry ice to maintain a temperature of -70°C ± 10°C. The containers contain thermal sensors with GPS to track the location and temperature of each vaccine shipment en route to distribution sites. Vaccine doses could be stored in the thermal containers for up to 30 days if the dry ice was refilled every five days.
If approved, the new storage conditions would allow the vaccine to be stored at temperatures as low as -25°C to -15°C (-13°F to 5°F) – a temperature range that any standard freezer can handle – for up to two weeks. And the vaccine doses can then be stored for another five days at standard refrigerator temperatures of 2⁰C to 8⁰C.
The companies report that as they continue to test the limits of the vaccine, they expect expiration dates to be extended as well.