On January 31, 2022, the FDA announced the second approval of a COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older. 

Spikevax is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 18 years of age and older. It is also authorized for emergency use to provide: 

  • A two-dose primary series to individuals 12 years through 17 years of age. 
  • A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. 

Moderna COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as a: 

  • Two-dose primary series for individuals 6 months of age and older. 
  • Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. 

Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 18 years of age and older as a single booster dose administered at least 2 months after either: 

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or 
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

On February 11, 2022, in consultation with FDA, CDC issued emergency use instructions to provide information about the primary, additional, and booster doses of the Moderna COVID-19 vaccines in certain individuals.
 

Moderna COVID-19 Vaccine Fact Sheets (English) and FAQs

Material Audience Vaccine Purpose Vaccine Recipient Group Last Updated
Fact Sheet Healthcare Providers Primary Series 6 months through 5 years of age (magenta border) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series 6 months through 5 years of age (magenta border) June 17, 2022
Fact Sheet Healthcare Providers Primary Series 6 years through 11 years of age (teal and purple border) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series 6 years through 11 years of age (teal & purple border) June 17, 2022
Fact Sheet Healthcare Providers Primary Series 12 years and older (light blue border) August 31, 2022
Fact Sheet Healthcare Providers Bivalent Booster 18 years and older (gray border) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series and Bivalent Booster 12 years and older (primary series) and 18 years and older (booster) (black border) August 31, 2022
Frequently Asked Questions on the Moderna COVID-19 Vaccine All All All February 16, 2022

Moderna COVID-19 Vaccine Regulatory Information

Media Materials and Webcasts

Translations of the Fact Sheet for Recipients and Caregivers
 

 

Translations of the Moderna Fact Sheet for Recipients and Caregivers for 6 months through 5 years of age
 

Translations of the Moderna Fact Sheet for Recipients and Caregivers for 6 through 11 years of age
 

Translations of the Moderna Fact Sheet for Recipients and Caregivers for 12 years of age and older