Pfizer/BioNTech’s Comirnaty mRNA Vaccine Authorized by FDA for Storage at Standard Freezer Temperatures for Up to Two Weeks

U.S. Food and Drug Administration (FDA) announced, approvedPfizer/Pfizer-BioNTech mRNA vaccine (brand name: Comirnaty) can be transported and stored for 2 weeks at standard pharmaceutical freezer temperatures (-25°C to -15°C) as an alternative or supplement to storage in ultra-low temperature (-80°C to -60°C) freezers.

Comirnaty is an mRNA vaccine developed jointly by Pfizer and BioNTech, based on BioNTech’s proprietary mRNA technology. The vaccine was approved by the European Union and the United States last December.FDAEmergency Use Authorization. For the prevention of COVID-19 infection in individuals aged 16 years and older. Global Phase IIIClinical TrialThe results showed that Comirnaty was 95% effective in preventing SARS-CoV-2 infection, with an efficacy of over 94% among adults aged 65 years and older. To date, the vaccine has been authorized for use by health regulatory authorities in more than 50 countries and regions, including the United Kingdom, the United States, Canada, and the European Union.

However, this vaccine previously required storage in ultra-low temperature freezers at -80°C to -60°C, where it could be preserved for up to 6 months. These stringent temperature requirements posed challenges for the transportation and storage of the vaccine.

Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, said, “Pfizer toFDAStability data were submitted to support this alternative temperature for vaccine transport and storage. This alternative temperature allows for greater flexibility in the transport and storage of vaccines, helps alleviate the burden on vaccination sites to procure ultra-low-temperature refrigeration equipment, and facilitates the delivery of vaccines to more locations.”BioonBioon.com）