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FDA amends Moderna COVID-19 vaccine EUA

Article

The move clarifies the number of doses that can be administered from each vial and approves larger vials.

FDA amends Moderna COVID-19 vaccine EUA

The Food and Drug Administration (FDA) has amended the emergency use authorization issued for the Moderna COVID-19 vaccine.

According to a news release, the agency has clarified the maximum number of doses of the vaccine in the vials currently available is 11. Another revision to the authorization authorizes additional multi-dose vials which can hold a maximum of 15 doses.

“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, says in the release. “Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly.”

There may not be enough volume to extract more than 10 doses from the currently available vials depending on the types of syringes and needles used to extract the doses. The same factors may lead to no more than 13 doses being extracted from the new larger vials, according to the release.

The move will increase the stock of available vaccines as Johnson & Johnson’s recently hit a snag in supplying their single-dose vaccine.

The Washington Post reports that the Biden administration has taken over responsibility for manufacturing at a drug pant in Baltimore which cross-contaminated 15 million doses of the vaccine. Despite the setback, the administration remains hopeful that the country will still have a sufficient supply to hit the president’s goal of enabling every adult to get immunized by the end of May.

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