Research & Development
The FDA reports two revisions to Moderna COVID-19 Vaccine to increase the availability in the number of doses
5 April 2021 -

The US Food and Drug Administration on Thursday announced two revised doses per vial for the Moderna COVID-19 Vaccine to positively impact the supply of the vaccine to provide more vaccine doses to communities.

According to the agency, the first revision clarifies the number of doses per vial for the vials that are currently available, in that 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.

Based on the type of syringes and needles used to extract each dose, 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 vial containing a maximum of 15 doses. However, the dosing regimen remains unchanged. The vaccine is administered as a two-dose series, 0.5 ml each dose, one month apart, added the agency.

In conjunction, the Fact Sheet for Healthcare Providers Administering Vaccine and Prescribing Information have been revised to reflect the new information to help frontline workers administering COVID-19 vaccines understand the number of doses that can be extracted per vial, concluded the agency.