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 18 years of age and older
- Third primary series dose for individuals 18 years 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
Information | Last Updated |
---|---|
Fact Sheet for Healthcare Providers – labels with purple borders | March 29, 2022 |
Fact Sheet for Healthcare Providers – labels with light blue borders | March 29, 2022 |
Important prescribing information for vaccine providers on booster dose volume (0.25mL) and vial presentation | October 21, 2021 |
Fact Sheet for Recipients and Caregivers | March 29, 2022 |
Frequently Asked Questions on the Moderna COVID-19 Vaccine | February 16, 2022 |
Moderna COVID-19 Vaccine Regulatory Information
Information | Date |
---|---|
Letter of Authorization (Reissued) | March 29, 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 |
---|---|
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