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FDA allows Moderna to put more coronavirus vaccine doses in each vial


The Food and Drug Administration said late Thursday that Moderna can put up to 50 percent more doses of vaccine in each vial, a change that will likely allow the company to speed up the pace of its shipments.

Moderna had been shipping 10-dose vials; the FDA’s decision allows the company to put up to 15 doses in each vial.

The agency also gave permission to vaccinators to extract 11 doses from existing 10-dose vials vials, depending on the availability of certain syringes and needles. Some pharmacies have already said that they have been able to eke extra doses from existing vials.

“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,” FDA vaccine regulator Peter Marks said in a statement. “Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly.”

An updated FDA fact sheet notes that without the proper syringes, it may not be possible to extract more than 10 doses from the original sized vial, or 13 doses from vials filled with more vaccine. The agency issued its decisions as amendments to its emergency use authorization for Moderna’s vaccine.

Easier storage: The FDA is also allowing Moderna’s vaccine to be kept at room temperature for 24 hours, up from 12 hours, according to the company. Once a vial is opened, vaccine can now be administered for 12 hours, an increase from the previous six hours.

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

Background: Moderna has been in discussions with the FDA since early February about its request to fill each vial with additional doses of Covid-19 vaccine.

A spokesperson for Moderna told POLITICO at the time that it would take two to three months to implement changes to how many doses are filled in each vial and that increasing the number of doses would not require different vials than the ones already being used.

What’s next: Moderna expects to begin shipping 15-dose vials in the coming weeks.

Sarah Owermohle contributed to this report.

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