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COVID-19 Vaccine Updates

April 1, 2021

FDA Revises Emergency Use Authorization for Moderna COVID-19 Vaccine


On April 1, 2021, the FDA revised the emergency use authorization (EUA) issued to ModernaTX, Inc. to help increase the number of vaccine doses available. The first revision clarifies that the maximum number of doses available in current vials is 11, with a range of 10-11. The second revision authorizes an additional multi-dose vial which contains a maximum of 15 doses, with a 13-15 dose range. The modified guidance notes that the number of doses that can be extracted from a vial depends on the type of syringe and needle being used. Therefore, fewer doses may be extracted from any individual vial.

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