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FDA authorizes 2 changes to Moderna’s vaccine

The FDA said it approved new vials from Moderna that can contain up to 15 doses each, compared with the original vials designed to hold 10 doses.

WASHINGTON — 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.

The dosing updates should help bolster U.S. supplies and speed vaccinations as the U.S. nears 100 million inoculations against COVID-19. President Joe Biden has vowed to provide enough shots to vaccinate all U.S. adults by late May and recently set a new goal of administering 200 million injections within his first 100 days in office.

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

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“We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs. Thank you to the U.S. FDA and CDC for their ongoing collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain focused on doing all that we can to help end the COVID-19 pandemic with a vaccine.”

The company added that it will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without compromising quality or safety.

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