Pharmacists Should Be Aware of Changes in Moderna Vaccine, Doses, Storage

Changes in the emergency use authorization for the Modern COVID-19 vaccine could both make the product easier to handle and increase supply. Find out what’s new with FDA guidance on use of the vaccine and what that means for pharmacists and other vaccinators.

CAMBRIDGE, MA – Pharmacists should find the Moderna COVID-19 vaccine easier to store and use, thanks to new authorizations from the Food and Drug Administration.

The FDA now says it is okay for the Moderna COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. In addition, a punctured vial is now considered useable for up to 12 hours, an increase from the previous 6 hours.

The new guidelines are part of an updated FDA Emergency Use Authorization (EUA) label for the vaccine, which is ready for use and does not need to be diluted.

Pharmacists also will notice significant changes in dosage. FDA revisions clarify the number of doses for the vials that are currently available, determining that the maximum number of extractable doses is 11, with a range of 10-11 doses and also authorize 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. Moderna says it expects the larger, 15-dose vials, should begin shipping in the next few weeks.

“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.

The FDA cautions, however, that 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. 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. were reviewed by the FDA and led to the changes.

Pharmacists and other vaccinators should refer to The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information, which has 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.

Public health officials emphasize that, 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. The reason is that, if one vial becomes contaminated, it could affect numerous vials.

Moderna explains it studied the possibility of adding more doses to each vial of vaccine to address bottlenecks, accelerate production and reduce the need for consumable materials that are in high demand.

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