Skip to Main Content
April 02, 2021

Health Law Weekly

FDA Revises Moderna Vaccine EUA to Boost Available Doses

  • April 02, 2021

The Food and Drug Administration (FDA) announced April 1 two revisions to the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine.

The first revision clarifies the number of doses per vial for the vials that are currently available. Under the revised EUA, the maximum number of extractable doses is 11, with a range of 10-11 doses.

The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.

“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. Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA first issued an EUA to Moderna on December 18, 2020.