Moderna to seek emergency authorization of coronavirus vaccine
Massachusetts-based biotech company Moderna announces it will request an Emergency Use Authorization from the FDA for its coronavirus vaccine; Dr. Nicole Saphier weighs in.
Moderna is the latest contender to announce the filing of emergency use authorization for its coronavirus vaccine, potentially adding another option to help combat the ongoing pandemic.
Moderna's vaccine, which was trialed as a two-dose injection to the arm spaced several weeks apart, uses the new gene technology messenger RNA (mRNA) platform, similar to Pfizer. But one of the major differences between the two is storage requirements, with Moderna boasting a shelf life of up to six months in a regular freezer, and up to 30 days in a standard refrigerator. Pfizer, on the other hand, said its vaccine must be stored at temperatures of minus 70 degrees Celsius or below.
Moderna’s less stringent storage requirements may bring a sigh of relief to desolate or hard-to-reach regions where the cold chain is a concern for distribution measures. But if it is approved, how quickly could those regions, and the rest of the world, see the vaccine ready for shipment?
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According to its latest statement, it may be a matter of weeks.
“Moderna is working with the U.S. CDC, Operation Warp Speed and McKesson, a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals,” according to a news release posted Monday. “By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 available in the U.S. The company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association issued a Current Procedural Terminology code to report vaccination with mRNA-1273. Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.”
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Speaking to CBS This Morning on Monday, Health and Human Services Secretary Alex Azar said that a decision on Moderna’s application for EUA will likely be made days or up to a week after Pfizer’s is considered on Dec. 10.
Azar added that the vaccines will “ship 24 hours after authorization,” meaning the country is potentially on track to see a vaccine distributed before Christmas.