Pfizer and BioNTech Submit New Stability Data for COVID-19 Vaccine to Enable Flexible Storage and Transport Conditions

Pfizer and BioNTech announced today that they have submitted new data to the U.S. FDA demonstrating the stability of their jointly developed COVID-19 vaccine at temperatures ranging from -25°C to -15°C, which are more commonly found in pharmaceutical freezers and refrigerators. The two companies are seeking to update the labeling information under the Emergency Use Authorization (EUA), which would allow the vaccine to be stored at these temperatures for a total of two weeks, as an alternative or supplement to storage in ultra-low temperature freezers.

The mRNA COVID-19 vaccine jointly developed by Pfizer and BioNTech has been approved for use in multiple countries and regions. In Phase 3 clinical trials, it demonstrated greater than 90% efficacy in preventing symptomatic COVID-19. However, the Emergency Use Authorization (EUA) labeling for this mRNA vaccine specifies that it must be stored in ultra-low temperature freezers at -80°C to -60°C. Under these conditions, the vaccine can be stored for up to six months. These stringent temperature requirements for storage have posed challenges for vaccine transportation and storage.

Submissions to the FDA include stability data from different batches produced during the nine-month COVID-19 vaccine development period. These batches encompass those used in the earliest clinical trials as well as those currently in commercial production. These data will also be submitted to global regulatory authorities in the coming weeks.

“We have been continuously conducting stability studies to support commercial-scale vaccine production, with the goal of making vaccines as accessible as possible to healthcare workers and people around the world,” said Mr. Albert Bourla, Chairman and Chief Executive Officer of Pfizer. “We are committed to ensuring that the vaccine can be transported and stored under increasingly flexible conditions. If approved, this new storage option will provide pharmacies and vaccination centers with greater flexibility in managing their vaccine supplies.”

Note: This article aims to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a qualified healthcare provider at an accredited hospital.

References:

[1] PFIZER AND BIONTECH SUBMIT COVID-19 VACCINE STABILITY DATA AT STANDARD FREEZER TEMPERATURE TO THE U.S. FDA. Retrieved February 19, 2021, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-0

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