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FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization

April 01, 2021: “The U.S. FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.

The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses.

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The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.

“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.

Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Depending on the type of syringes and needles used to extract each dose, there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses.

To support these changes to the emergency use authorization, the FDA evaluated data showing the number of doses that could be extracted from the vials and on the fill volumes for both vials that were submitted by ModernaTX, Inc. 

The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information have been revised to reflect the new information and are intended to help frontline workers administering COVID-19 vaccines understand the number of doses that can potentially be extracted per vial.

Because the Moderna COVID-19 Vaccine does not contain preservative, any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one full dose.

If one vial becomes contaminated during use, pooling doses from multiple vials can spread contamination to other vials. Use of contaminated vials may cause serious bacterial infections in vaccinated individuals.

The updated information in the revised Fact Sheet for Vaccination Providers and Prescribing Information provides instructions to not pool vaccine from multiple vials.

The dosing regimen remains unchanged; the vaccine is administered as a two-dose series, 0.5 mL each dose, one month apart.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-makes-two-revisions-moderna-covid-19-vaccine-emergency-use

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