Moderna Announces Extended Stability Conditions for COVID-19 Vaccine Candidate
Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.
Moderna reported in a Nov. 16, 2020 press release that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days; new stability testing data support this extension from an earlier estimate of seven days. The press release explained that mRNA-1273 remains stable at -20 °C (-4 °F) for up to six months, at refrigerated conditions for up to 30 days, and at room temperature for up to 12 hours. Moderna announced on the same day that the vaccine candidate had met its primary efficacy endpoint in the Phase III trial.
“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, chief technical operations and quality officer at Moderna, in the press release. “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20 °C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”
Moderna plans for temperatures of -20°C (-4°F), which is an established range attainable with standard freezers, for shipping and longer-term storage. The vaccine can be stored, after thawing, at refrigerated conditions, which allows for storage at most pharmacies, hospitals, or physicians’ offices. In addition, the vaccine will not require onsite dilution or special handling, the company reported in the press release.
Moderna said it will continue to collect and assess stability information in the coming months, which could lead to more flexible storage recommendations. Moderna is working with the US Centers for Disease Control and Prevention, Operation Warp Speed, and McKesson (a COVID-19 vaccine distributor contracted by the US government), as well as global stakeholders, to prepare for distribution following authorization.
Source: Moderna
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