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On April 1, the FDA authorized an amendment to the Moderna COVID-19 vaccine EUA. The new EUA documents can be found here:
Summary of Changes for Vaccinators
Storage and Handling
The FDA announced three revisions regarding storage and handling of Moderna COVID-19 Vaccine:
- Moderna vials can now be stored between -50 °C to -15 °C. This is an expanded temperature range that is now consistent with other recommended vaccines stored in the freezer.
- Unpunctured vials may be stored at room temperature for a total of 24 hours (an increase from 12 hours).
- Punctured vials may be stored for up to 12 hours. Vials should be discarded 12 hours after the first puncture (an increase from 6 hours).
Multi-dose Vial Presentation
The FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine:
- The EUA was clarified to indicate that currently available vials have a maximum of 11 doses, with a range of 10-11 doses that can potentially be extracted.
- If you are unable to obtain the 11th dose, it does not need to be marked as “wasted” in WIR, and a Vaccine Wastage Form does not need to be submitted.
- The EUA now indicates that Moderna COVID-19 vaccine will be available in another multi-dose vial option that contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.
- More information about the 15-dose vial is forthcoming from CDC. DHS will send follow-up communications to vaccinators as we receive updates from CDC.
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.
As a reminder, do not pool COVID-19 vaccine. Combining any remaining product that does not constitute a full dose from multiple vials to create one full dose should not be done. 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 Health Care Providers includes instructions to not pool vaccine from multiple vials.
The FDA announced two EUA revisions relevant to recipients of Moderna COVID-19 vaccine:
- Added severe allergic reactions to the risks.
- Added two new sections entitled, “Can I be charged an administration fee for receipt of the COVID-19 vaccine,” and “Where can I report cases of suspected fraud.”
CDC is currently reviewing the updated EUA information, including the recipient and provider fact sheets, to assess how the amendment will affect the COVID-19 vaccination program, including clinical guidance, distribution, and data systems.
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