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WASHINGTON (REUTERS) – The U.S. Food and Drug Administration said Wednesday (Dec. 16) that additional doses of Pfizer’s Covid-19 vaccine vials may be used after reports that pharmacists dispose of vaccine doses due to labeling confusion.
Stat News previously reported that hospital pharmacists found themselves in a position to discard one in six doses of the first Pfizer-BioNTech Covid-19 vaccines distributed this week in the United States due to confusion over labeling.
The Pfizer vials are supposed to contain five doses, depending on the labeling, but media reports said pharmacists had found a way to get a sixth or even a seventh dose. Without clear approval from the manufacturer, the additional dose had to be discarded.
“At this time, given the public health emergency, the FDA advises that it is acceptable to use every full dose that can be obtained (the sixth, or possibly even the seventh) from each vial, until the problem is resolved,” said a FDA representative in an emailed statement.
“However, since the vials do not contain preservatives, it is critical to note that any additional remaining product that does not constitute a full dose should not be combined from multiple vials to create one,” the statement added.
The launch of the first 2.9 million dose tranche of the newly licensed vaccine from Pfizer and German partner BioNTech SE continued for a third full day, with shipments going to 66 more distribution centers in the United States.
A second Moderna vaccine could get emergency use approval from the FDA this week.
An additional 2 million doses of the Pfizer vaccine and 5.9 million doses of the Moderna vaccine could be assigned next week, US Secretary of Health and Human Services Alex Azar said in a conference call on Wednesday. Two doses of the vaccines, given three to four weeks apart, would be required for each person inoculated.
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