FDA Authorizes Fuller Vials for Moderna's COVID-19 Vaccine

Carolyn Crist

April 05, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The FDA authorized Moderna to add more coronavirus vaccine doses into its vials on Thursday, bumping the range up to between 11 to 15 doses that can be extracted.

The FDA approved new vials from Moderna that can contain up to 15 doses, and the agency said the current 10-dose vials can safely extract up to 11 doses.

"Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly," Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.

The move is anticipated to further increase U.S. vaccine supply in the coming weeks and could speed up Moderna's delivery timeline, according to The New York Times. Moderna has pledged to deliver 200 million doses by the end of May and 300 million by the end of July.

In anticipation of the FDA's approval, Moderna had already begun producing vials with more doses, the newspaper reported. The FDA told the company six weeks ago that it was in favor of increasing the number of doses. Moderna will begin shipping the 15-dose vials in the coming weeks, the company said in a statement on Thursday.

"We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs," Stéphane Bancel, the CEO of Moderna, said in the statement.

The FDA evaluated data from Moderna that showed how many doses could be safely extracted from the different vials and updated its fact sheet for health care providers to help frontline workers understand how many doses they can extract based on the type vial used.

Sources

FDA, "FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available."

New York Times, "The F.D.A. authorizes fuller vials from Moderna, a boost to vaccine supplies."

Moderna, "Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15-Doses Per Vial of its COVID-19 Vaccine."

FDA, "Fact sheet for healthcare providers administering vaccine: Emergency use authorization of the Moderna COVID-19 vaccine."

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....