FDA Authorizes Moderna To Provide More COVID-19 Vaccine Doses In Each Vial
The U.S. Food and Drug Administration authorized two changes to Moderna’s COVID-19 vaccine that will provide more doses from each vial of the vaccine.
The FDA authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine.
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.
“Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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.
However, the dosing regimen remains unchanged. The vaccine is administered as a two-dose series, 0.5 mL each dose, one month apart.
Moderna said it plans to begin shipping the new 15-dose vials in coming weeks.
The dosing updates will help increase the number of vaccine doses available and speed up vaccinations in the U.S.
President Joe Biden has aimed to provide enough shots to vaccinate all U.S. adults by late May and recently issued a new goal of administering 200 million shots within his first 100 days in office.
The FDA also 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.
In addition, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours.
In December 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.
Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.
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