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



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“These two revisions have a positive impact on the supply of Moderna COVID-19 vaccine, which will help deliver more doses of vaccine to communities and allow injections to pick up speed faster,” the vaccine regulator said. FDA Peter Marks in a statement. “Ultimately, more vaccines available to the public in a timely manner should help end the pandemic faster.

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 size vial or 13 doses from vials filled with more vaccine. The agency released its decisions as amendments to its emergency use authorization for Moderna’s vaccine.

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

“We are committed to constantly learning and improving to make it easier to deliver our COVID-19 vaccine to medical staff and speed up vaccination programs,” Moderna CEO Stéphane Bancel said in a statement.

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

A Moderna spokesperson told POLITICO at the time that it would take two to three months to implement changes to the number of doses filled in each vial and that increasing the number of doses would not require additional doses. vials different from those already used.

And after: Moderna plans to start shipping 15-dose vials in the coming weeks.

Sarah Owermohle contributed to this report.

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