Spikevax and Moderna COVID-19 Vaccine
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.
Moderna COVID-19 Vaccine is authorized for emergency use 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.
- First booster dose for individuals 18 years of age and older at least five months after completing a primary series of the Moderna COVID-19 Vaccine or Spikevax vaccine.
- First booster dose for individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for this first booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
- Second booster dose for individuals 50 years of age and older at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
- Second booster dose for individuals 18 years of age and older with certain kinds of immunocompromise at least four months after receipt of a first booster dose of any authorized or approved 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.
Spikevax Information
Information | Last Updated |
---|---|
Package Insert | January 31, 2022 |
Patient Package Insert | January 31, 2022 |
Approval Letter | January 31, 2022 |
Summary Basis for Regulatory Action | January 30, 2022 |
Frequently Asked Questions (Español) | February 8, 2022 |
CDC-issued Emergency Use Instructions | February 11, 2022 |
Moderna COVID-19 Vaccine Fact Sheets (English) and FAQs
Material | Audience | Vaccine Recipient Group | Last Updated |
---|---|---|---|
Fact Sheet | Healthcare Providers | 6 months through 5 years of age (magenta border) | June 17, 2022 |
Fact Sheet | Recipients and Caregivers | 6 months through 5 years of age (magenta border) | June 17, 2022 |
Fact Sheet | Healthcare Providers | 6 years through 11 years of age (teal & purple border) | June 17, 2022 |
Dear Healthcare Provider Letter | Healthcare Providers | 6 years through 11 years of age (purple border on vial) | June 17, 2022 |
Fact Sheet | Recipients and Caregivers | 6 years through 11 years of age (teal & purple border) | June 17, 2022 |
Fact Sheet | Healthcare Providers | 12 years and older and booster doses for 18 years and older (light blue border) | June 17, 2022 |
Fact Sheet | Recipients and Caregivers | 12 years and older (black border) | June 17, 2022 |
Fact Sheet | Healthcare Providers | 18 years and older booster dose presentation only (purple border) | June 17, 2022 |
Wall Chart | Healthcare Providers | All | June 17, 2022 |
Frequently Asked Questions on the Moderna COVID-19 Vaccine | All | All | February 16, 2022 |
Moderna COVID-19 Vaccine Regulatory Information
Information | Date |
---|---|
Letter of Authorization (Reissued) | June 17, 2022 |
Decision Memorandum | March 28, 2022 |
Decision Memorandum | January 6, 2022 |
Decision Memorandum Addendum | December 30, 2021 |
Letter Granting EUA Amendment | December 9, 2021 |
Decision Memorandum | November 19, 2021 |
Decision Memorandum Addendum | November 19, 2021 |
Decision Memorandum Addendum | November 18, 2021 |
Memorandum to the File | October 20, 2021 |
Decision Memorandum | October 20, 2021 |
Advisory Committee Meeting Information | October 14, 2021 |
Letter Granting EUA Amendment | August 30, 2021 |
Decision Memorandum | August 12, 2021 |
Letter Granting EUA Amendment | June 25, 2021 |
Letter Granting EUA Amendment | April 1, 2021 |
FDA Decision Memorandum | December 18, 2020 |
Advisory Committee Meeting Information | December 17, 2020 |
Media Materials and Webcasts
Information | Date |
---|---|
Press Conference | June 17, 2022 |
Press Release | June 17, 2022 |
Advisory Committee Webcast | June 15, 2022 |
Advisory Committee Webcast | June 14, 2022 |
Media Call | March 29, 2022 |
Press Release | March 29, 2022 |
Press Release | January 31, 2022 |
Press Release | January 7, 2022 |
Press Release | November 19, 2021 |
Press Release | October 20, 2021 |
Media Call | October 20, 2021 |
Advisory Meeting Webcast | October 14, 2021 |
Press Release | August 12, 2021 |
Press Release | April 1, 2021 |
Press Release | December 18, 2020 |
Media Call | December 18, 2020 |
Advisory Committee Webcast | December 17, 2020 |
Translations of the Fact Sheet for Recipients and Caregivers