FDA Increased the Maximum Doses per Vial for Moderna COVID-19 Vaccine

In an April 1, 2021 statement, the FDA announced the authorization of a new multi-dose vial of Moderna's COVID-19 vaccine that contains up to 15 doses.

The US Food and Drug Administration (FDA) authorized the availability of a new multi-dose vial of Moderna’s COVID-19 vaccine candidate in which each vial now can contain a maximum of 15 doses, with a range of 13-15 doses that can be potentially extracted.

In parallel, the FDA also authorized a maximum of 11 doses with a range of 10-11 doses for the vials that are currently available, an increase 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. 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, Center for Biologics Evaluation and Research, FDA, in the agency’s April 1, 2021 press release.

Depending on the type of syringes and needles being used to extract each dose of the COVID-19 vaccine, there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses, or more than 13 doses from the one containing a maximum of 15 doses, noted the press release.

The FDA’s decision to make these changes came after the agency evaluated data that showed the number of doses that could be extracted and on the fill volumes for both vials that were submitted by ModernaTX, Inc. These revisions are reflected in an updated Emergency Use Authorization.

The FDA stressed that because the Moderna COVID-19 vaccine does not have preservatives, any remaining product should not be pooled from multiple vials to create a full dose, in order to prevent cross contamination between vials.

It is also important to note that the dosing regimen remains the same regardless of these revisions. The Moderna COVID-19 vaccine should be administered as a 2-dose series, 0.5 mL each dose given 1 month apart.