FDA grants Moderna permission to increase doses in each bottle from 10 to 14: report

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

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

One of the biggest restrictions on Moderna’s manufacturing capacity is how many bottles can be filled.

“In order to better maximize resources, as well as maximize opportunities to deliver more doses to each market more quickly, Moderna has proposed filling bottles with up to 15 doses of the vaccine compared to the previous 10 doses,” said a spokesman from Moderna to Fox News on Friday.

The FDA said Friday that it cannot comment on discussions it is having with a manufacturer.

“Generally speaking, any change in a [Emergency Use Authorization] it must be requested by the company and include data that support the requested change and would be authorized through 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 supplies about half of America’s vaccine supply. Since increasing the number of doses per bottle would not require different bottles from those currently in use, it would be a simple way to increase the number of doses available. The manufacturing change would take two to three months to implement.

President Joe Biden said on Thursday that the U.S. 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 fully vaccinate almost all Americans.

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

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

Moderna was contracted to supply 300 million doses to the United States and another 341.5 million doses to countries around the world.

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

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

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