Moderna Vaccine EUA and National Drug Code (NDC) Amendments
Attention COVID-19 Vaccine Providers, as of April 26, 2021, there have been recent amendments to both the Moderna COVID-19 Vaccine Emergency Use Authorization (EUA) and the issuance of a new National Drug Code (NDC). These changes include:
- Increase in the fill volume of the vaccine vials
- New labeling for the existing vial and the upcoming larger volume vial
- Modifications to storage and handling temperatures
PDPH is planning to transition from both NDCs in early May to a single NDC for the larger volume vial by the end of May. Some changes to note are:
Ancillary Kits: The new ancillary kits will support administration of 140 doses of vaccine and will be optimized to extract 14 doses per vial.
Wastage: Partners and jurisdictions may see an increase in reported wastage. We know there is always waste with vaccine administration and that an increase in wastage could cause concern for leaders. We recommend jurisdictions communicate with their stakeholders about these metric changes. Please reference the Wastage Reporting Table for reminders on when to report wastage. Note: An unextracted 15th dose from the larger volume Moderna vial does NOT result in reportable waste.
Please review and download the following resources to learn more about the Moderna EUA amendments:
- Moderna EUA Talking points to use in communication with providers
- Moderna EUA Frequently Asked Questions
- Images of new Moderna cartons and vial labels
- Wastage Reporting Table
Thank you for keeping Philadelphia safe and healthy from COVID-19. If you have any questions, please email email@example.com.