FDA revises authorization on doses available per vial of Moderna’s COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 vaccine, according to a news release from the agency.
The first revision clarifies that the maximum number of extractable doses per vial is 11, with a range of 10-11 doses. In the second revision, the FDA authorized the use 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.
Depending 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, the FDA said.
Because the Moderna COVID-19 vaccine does not contain preservatives, any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one full dose. If one vial becomes contaminated during use, pooling doses from multiple vials can spread contamination to other vials, the FDA cautioned.
