FDA grants Modern permission to increase doses in each vial from 10 to 14: report

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

Moderna did not confirm the approval Friday, but told Fox News it is currently in talks with the FDA about a “possible increase in filling volumes, which could extract the extra dose of each bottle available.”

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

“To better maximize Modern resources and maximize opportunities to deliver more doses in each market faster, Moderna suggested filling the scales with up to 15 doses of vaccine compared to the previous 10 doses,” a spokeswoman for Moderna told Fox on Friday. News said.

The FDA said Friday it could not comment on discussions it was having with a manufacturer.

‘In general, any changes to a [Emergency Use Authorization] must be requested by the company and contain the data that supports the requested change. “This will be granted through a letter of consent or the reissue of the letter of authority that will be posted on the FDA’s website,” an FDA spokesman told Fox News.

Modern currently supplies about half of America’s vaccine supply. Because the increased number of doses per vial does not require vials other than those currently in use, this is a simple way to increase the available doses. The manufacturing change will take two to three months to implement.

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

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

The FDA is currently considering a request for emergency authorization by a third drug company, Johnson & Johnson, for its COVID-19 vaccine.

Moderna has been contracted to supply 300 million doses to the US 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 according to the CDC in the United States.

Moderna’s increased manufacturing capability comes as COVID-19 variants spread rapidly across the country.

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