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FDA issues amendments to EUA for the Moderna vaccine

The FDA issued amendments to its emergency use authorization for Moderna's vaccine to make more vaccinations possible. The amendments include giving permission to vaccinators to extract 11 doses from existing 10-dose vials, depending on the availability of certain syringes and needles. And, the FDA is allowing Moderna's vaccine to be kept at room temperature for 24 hours, up from 12 hours. Once a vial is opened, the vaccine can now be administered for 12 hours, an increase from the previous six hours.

The Food and Drug Administration said late Thursday that Moderna can put up to 50 percent more doses of vaccine in each vial, a change that will likely allow the company to speed up the pace of its shipments.


covid-19, fda, health care & life sciences