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Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15-Doses Per Vial of its COVID-19 Vaccine
U.S. EUA label allows for vaccine vials to remain at room temperature conditions for a longer period (total of 24 hours from previous 12 hours) Label update
About this update from Moderna, Inc.
[{"type":"text","content":"\nU.S. EUA label allows for vaccine vials to remain at room temperature conditions for a longer period (total of 24 hours from previous 12 hours)\n\nLabel update also allows for two vial presentations (maximum of 15 doses and maximum of 11 doses)\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that based on submitted stability data, the U.S. Food and Drug Administration (FDA) has authorized the Moderna COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours. These new guidelines are reflected in an updated Emergency Use Authorization (EUA) label. The Moderna COVID-19 Vaccine is ready for use and does not need to be diluted.\n\nThe FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, from the previously authorized 10 doses per vial. The Moderna COVID-19 Vaccine now can be supplied in two vial presentations (a multiple-dose vial containing a maximum of 11 doses or a multiple-dose vial containing a maximum of 15 doses). The Company expects that the 15-dose vials will begin shipping in the coming weeks.\n\n“We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs. Thank you to the U.S. FDA and CDC for their ongoing collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain focused on doing all that we can to help end the COVID-19 pandemic with a vaccine.”\n\nModerna is continually learning, adapting and working closely with its partners and the U.S. government to identify ways to facilitate accelerated vaccine administration, address bottlenecks and accelerate production. One identified constraint on the production process has been the capacity of the fill-and-finish process. Moderna studied the possibility of adding more doses to each vial of vaccine to address bottlenecks, accelerate production and reduce ...