The FDA grants permission to Moderna to increase the doses in each vial from 10 to 14: report

The Food and Drug Administration (FDA) granted Moderna permission to increase the number of COVID-19 vaccine doses per vial from 10 to 14, according to the New York Times.

Modern did not confirm approval Friday, but told Fox News that it is currently in discussions with the FDA about a “potential increase in fill volumes, allowing the extraction of additional doses from each vial delivered.”

One of the biggest limitations to Moderna’s manufacturing capacity is the amount of vials that can be filled.

“In order to better maximize resources and maximize opportunities to administer more doses in each market more quickly, Moderna has proposed filling vials with up to 15 doses of vaccine compared to the previous 10 doses,” a Moderna spokesman told Fox News Friday.

The FDA said Friday it cannot comment on discussions it has with a manufacturer.

“In general, any change to one [Emergency Use Authorization] must be requested by the company and include data supporting the requested change and would be authorized by a letter of grant or reissue of the letter of authorization, which would be posted on the FDA website. ” an FDA spokesman told Fox News.

Moderna currently provides approximately half of the vaccine supply in the United States. Because increasing the number of doses per vial would not require vials other than those currently in use, it would be an easy way to increase the number of doses available. The manufacturing change would take two to three months to implement.

President Joe Biden said Thursday that the United States is on track to deliver more than 600 million doses of the COVID-19 vaccine between Modern and Pfizer by the end of July, enough to completely vaccinate almost every American.

“Just this afternoon we signed the final contracts for 100 million more modern vaccines and 100 million more Pfizer vaccines,” Biden said Thursday at the National Institutes of Health. “We can also advance delivery dates with an additional 200 million vaccines by the end of July, faster than we expected.”

The FDA is currently considering an application for emergency use authorization from a third-party pharmaceutical company, Johnson & Johnson, for its COVID-19 vaccine.

Modern is contracted to supply 300 million doses in the US and another 341.5 million doses to countries around the world.

To date, 69,014,725 doses and 48,410,558 doses have been distributed in the United States, according to the CDC.

Moderna’s expanded manufacturing capacity comes as COVID-19 variants continue to expand rapidly across the country.

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