SPIKEVAX

Important Prescribing Information from Moderna

 On September 11, 2023, the U.S. Food and Drug Administration:

  • authorized Moderna COVID-19 Vaccine (2023-2024 Formula) for Emergency Use in individuals 6 months through 11 years of age.

  • approved SPIKEVAX (COVID-19 Vaccine, mRNA) (2023-2024 Formula) for use in individuals 12 years of age and older.

  • removed authorization for use of Moderna COVID-19 Vaccine, Bivalent for use in the U.S.

The COVID-19 vaccines (2023-2024 Formula) are monovalent and encode the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5.

Moderna COVID-19 Vaccine (2023-2024 Formula) authorized for ages 6 months through 11 years is supplied in single dose vials. SPIKEVAX (2023-2024) Formula approved for ages 12 years and older is supplied in single dose vials and single dose pre-filled syringes (see table below).

Should you have any questions about the use of Moderna COVID-19 Vaccine (2023-2024 Formula) or SPIKEVAX (COVID-19 Vaccine, mRNA) (2023-2024 Formula), you can either contact your PRN Administrator or you can contact the Moderna Medical Information Contact Center at 1-866-MODERNA (1-866-663-3762) or visit www.modernatx.com/covid19vaccine-eua or www.spikevax.com or for additional resources.