The Food and Drug Administration (FDA) has authorized Moderna 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 talks with the FDA about a “possible increase in fill volumes, which will allow additional doses to be extracted from each vial dispensed.”
One of the biggest limitations on Moderna’s production capacity is the number of bottles that can be filled.
“To better maximize resources and maximize the opportunities to deliver more doses to each market more quickly, Moderna has proposed filling vials with up to 15 doses of vaccine compared to the previous 10 doses,” a Moderna spokesperson told Friday. Fox News.
The FDA said on Friday it cannot comment on any discussions it has with a manufacturer.
“In general, changes can be made to a [Emergency Use Authorization] must be requested by the company and include data supporting the requested change and would be authorized through an award letter or reissue of the authorization letter, which will be posted on the FDA’s website, ”an FDA spokesperson told Fox News.
Moderna currently supplies about half of the US vaccine supply. Since the larger number of doses per bottle does not require any other bottles than those currently in use, it would be an easy way to increase the number of doses available. The production change would take two to three months.
President Joe Biden said Thursday that the US 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 nearly every American.
“This afternoon, we signed final contracts for an additional 100 million Moderna and 100 million Pfizer vaccines,” Biden said at the National Institutes of Health on Thursday. “We are also able to increase delivery dates by 200 million additional vaccines by the end of July, faster than we expected.”
The FDA is currently considering an emergency authorization request from a third drug company, Johnson & Johnson, for its COVID-19 vaccine.
Moderna has been contracted to deliver 300 million doses to the US and an additional 341.5 million doses to countries around the world.
According to the CDC, 69,014,725 doses have been distributed and 48,410,558 doses administered in the United States to date.
Moderna’s scaled-up production capacity is due to COVID-19 variants continuing to spread rapidly across the country.