Pfizer and BioNTech announced Friday that their vaccine can be stored at higher than the ultra-low temperatures they had previously specified.
The companies announced they have submitted new data to the U.S. Food and Drug Administration (FDA) that shows the COVID-19 vaccine can be stored at -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), proposing a new update to the Emergency Use Authorization (EUA) prescribing information.
“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer’s Chairman and CEO Albert Bourla said in a statement.
The vaccine, which uses new so-called mRNA technology, can be stored at the specified higher temperatures for up to two weeks, the companies announced. Pharmaceutical freezers and refrigerators would be able to facilitate these higher temperatures. The companies say this approach can be used “as an alternative or complement to storage in an ultra-low temperature freezer.”
The FDA granted an EUA for the Pfizer-BioNTech vaccine in December 2020. Labels for the vaccine currently say that vials have to be stored in ultra-cold freezers at temperatures between -80 and -60 degrees Celsius (-112 to ‑76 degrees Fahrenheit), and can remain stored for up to six months.
The data the companies submitted to the FDA includes “stability data” generated on batches of vaccines that were made over the past nine months. The same data will also be submitted to other global regulatory agencies over the next few weeks, Pfizer and BioNTech announced.
“Our top priority was to quickly develop a safe and effective vaccine and make it available to the most vulnerable people in the world in order to save lives. At the same time, we have continuously collected data that could enable storage at around -20 degrees Celsius,” CEO and Co-founder of BioNTech Ugur Sahin said in a statement.
“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility. We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use,” he added.
Currently, according to the labels for the vaccine, it is shipped in specially-designed cool boxes filled with dry ice that has to be refilled every five days. The vaccine can remain in temporary storage for up to 30 days.
Once out of ultra-low temperature storage, the vaccine must be kept at a standard refrigerator temperature of between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit) to remain effective for up to five days.
According to Pfizer and BioNTech, the option to store at -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit) for two weeks would be in addition to the five-day option to store at standard refrigerator temperature. As per protocol, the vaccine is administered at room temperature.
Pfizer’s vaccine was the first time the FDA has approved for EUA a product that uses messenger RNA (mRNA) technology.
“The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein,” the FDA announcement reads. “When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”
Vaccine providers are required to report any serious adverse effects or vaccination administration errors to the Vaccine Adverse Event Reporting System, hosted by Health and Human Services. Vaccine manufacturers are immune from liability for any adverse reactions.