FDA Makes Revisions to Moderna’s COVID-19 Vaccine EUA to Increase Available Doses

BioPharm International Editors

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

On April 1, 2021, FDA announced two revisions to the Moderna COVID-19 vaccine Emergency Use Authorization (EUA) to increase the number of vaccine doses available.

The first revision further clarifies the number of doses per vial for the vials that are already available, with the maximum number of 11 extractable doses, with a range of 10–11 doses, FDA said in a company press release. The second revision allows for the availability of an additional multi-dose vial which contains a maximum of 15 doses, with a range of 13–15 doses that can potentially be extracted.

Depending on the type of syringe and needle used to extract each dose, FDA warned that there may not be enough volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses, according to the press release.

“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, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in the press release.

Source: FDA