COVID-19: FDA says extra doses of Pfizer vaccine can be used after labelling confusion

Hospital pharmacists in the US have been throwing out extra COVID-19 vaccine doses as the country battles with record numbers of infections and deaths.

One in every six doses of the first Pfizer/BioNTech vaccines distributed in the US this week were disposed of due to confusion over labelling, Stat News reported.

On Wednesday, the US Food and Drug Administration (FDA) clarified that extra doses from vials of the vaccine can be used.

The Pfizer vials are supposed to hold five doses, according to the labelling, however US media reported that pharmacists had found a way for a sixth or even a seventh dose.

But without clear approval from the manufacturer, the extra doses had to be discarded.

The FDA later said in a statement that “it is acceptable to use every full dose obtainable”.

“The FDA is aware that some vials of the Pfizer-BioNTech #COVID19 Vaccine have contained extra product after five doses are obtained. The agency is working with Pfizer to determine the best path forward, and will share additional updates as we have them,” the statement said.

“At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue.”

It added: “However, since the vials are preservative free, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.”

The US, the hardest-hit country in the world by the virus, is currently dealing with a surge in infections, reporting 250,000 new cases and a record high of over 3,700 deaths on Wednesday, according to Johns Hopkins University.

The rollout of the first batch of 2.9 million doses of the recently approved Pfizer vaccine is continuing, with shipments heading to 66 more distribution hubs across the country.

Vice President Mike Pence is expected to receive his first jab on Friday, with president-elect Joe Biden getting his first dose next week.

The Moderna vaccine could be the second to win emergency-use approval from the FDA this week.

An additional 2.9 million doses of the Pfizer vaccine and 5.9 million doses of the Moderna vaccine could be allocated next week, according to US Health and Human Services Secretary Alex Azar.

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