FDA Boosts Maximum Doses in Vials of Moderna COVID-19 Vaccines

April 7, 2021
Gabrielle Ientile, Assistant Editor

The FDA has made revisions to the emergency use authorization for the Moderna COVID-19 vaccine.

A recent FDA announcement has clarified important dosage information for the 2 types of vials for the Moderna COVID-19 vaccine and stated that it will allow Moderna to offer vials with even more doses.

The agency clarified that the vials currently being used have a maximum of 11 extractable doses, with a range of 10 to 11 doses, and that Moderna has also made available multi-dose vials that each contain a maximum of 15 doses, with a range of 13 to 15 doses, depending on the type of syringe and needle used.

The update on vial volumes stems from data submitted by Moderna and the updated information can be accessed through the fact sheet for health care providers who are administering the vaccine.

Related: Moderna, Pfizer Vaccines Safe and Effective in Pregnant, Lactating Women

The dosing regimen for both vial types has not changed; as such, the Moderna vaccine should still be administered in 2 doses of 0.5 mL each, 1 month apart.

The fact sheet details differences in the thawing of vaccine vials, however. The 11-dose-maximum vials should be thawed either in refrigerated conditions (2°-8° C) for 2 hours and 30 minutes and then kept at room temperature for 15 minutes before administering or thawed at room temperature (15°-25° C) for 1 hour. However, the 15-dose-maximum vials should be either thawed in the refrigerator for 3 hours and then kept at room temperature for 15 minutes or thawed at room temperature for 1 hour and 30 minutes before administering to patients.

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Leftover vaccine from a vial that is less than 0.5 mL cannot be combined with other doses from other vials, as the Moderna vaccine does not contain preservative and “if one vial becomes contaminated during use, pooling doses from multiple vials can spread contamination…[and] may cause serious bacterial infections in vaccination individuals,” the news release warned.

The revisions should facilitate more vaccines getting into the arms of Americans and bring the end of the COVID-19 pandemic one step closer. “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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

The Moderna COVID-19 vaccine has been authorized, but not approved, for the prevention of COVID-19 for individuals 18 years of age and older.

Reference

  1. Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available. News Release; April 1, 2021. Accessed April 6, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-makes-two-revisions-moderna-covid-19-vaccine-emergency-use.