Moderna gets FDA nod to speed up virus vaccine output with bigger vials

Updated: Apr 2, 2021 / 05:22 AM CDT

A worker readies syringes with the Moderna COVID-19 vaccine Monday, March 29, 2021, at “Vaccine Fest,” a 24-hour COVID-19 mass vaccination event in Metairie, La., just outside New Orleans, hosted by Ochsner Health System and the Jefferson Parish Government. Every adult in Louisiana over the age of 16 is now eligible to get vaccinated against the coronavirus as the state’s expanded eligibility went into effect Monday. (AP Photo/Gerald Herbert)

WASHINGTON (NewsNation Now) — The U.S. Food and Drug Administration has authorized two changes to Moderna’s COVID-19 vaccine that can provide extra doses from each vial.

The agency said late Thursday it approved new vials from Moderna that can contain up to 15 doses each, compared with the original vials designed to hold 10 doses. Additionally, regulators said providers can safely extract up to 11 doses from the original 10-dose vials. Those changes will be added to instructions for health care workers.

Moderna said in a statement it plans to begin shipping the new 15-dose vials in coming weeks. The company submitted updated data to FDA showing how much vaccines can be extracted from each vial using different types of syringes.

“Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said.

However, the regulator also warned that without proper syringes and needles it may not be possible to extract more that 13 doses from Moderna’s 15 dose vials, and more than 10 doses from the current vials.

An updated FDA emergency use authorization label also allows the vaccine vials to remain out at room temperature for a longer period of time, increasing from 12 hours to 24.

Moderna has supplied 100 million doses of its vaccine to the United States as of March 29. Pfizer/BioNTech and Johnson & Johnson’s shots are the other two vaccines approved in the country.

With rising cases and several states even lifting mask mandates and with more infectious variants also spreading, health authorities are hoping that the contracts it struck with the currently approved vaccine makers will be enough for its entire population.

U.S. top infectious diseases doctor Anthony Fauci told Reuters on Thursday that the country may not need AstraZeneca’s COVID-19 vaccine even if it wins regulatory approval.

About 56 million people, or 16.9% of the U.S. population, have been fully inoculated with COVID-19 vaccines made by Pfizer Inc/ BioNTech SE, Moderna Inc and Johnson & Johnson, according to CDC data. 30% of the U.S. population, or 99.6 million adults had received at least one dose of a COVID-19 vaccine.