#FDA grants Moderna permission to increase 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, the New York Times reports. 

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

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

“In order to better maximize resources as well as maximize opportunities to deliver more doses into each market faster, Moderna has proposed filling vials with up to 15 doses of vaccine versus the previous 10 doses,” a Moderna spokesperson told Fox News Friday. 

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

“Generally speaking, any changes to an [Emergency Use Authorization] must be requested by the company and include data supporting the requested change and would be authorized via a granting letter or reissuance of the letter of authorization, which would be posted on FDA’s web site,” an FDA spokesperson told Fox News. 

Moderna currently provides roughly half of America’s vaccine supply. Because the increased number of doses per vial would not require different vials than the ones currently being used, 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 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 every American. 

“Just this afternoon, we signed the final contracts for 100 million more Moderna and 100 million more Pfizer vaccines,” Biden said Thursday at the National Institutes of Health. “We’re also able to move up the delivery dates with an additional 200 million vaccines to the end of July, faster than we expected.”

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

Moderna is contracted to supply 300 million doses to the U.S. and another 341.5 million doses to countries around the world. 

So far, 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 scaled-up manufacturing capacity comes as COVID-19 variants continue to rapidly spread throughout the country.