Spikevax and Moderna COVID-19 Vaccine
March 29, 2022: FDA authorizes a second booster dose of Pfizer-BioNTech or Moderna COVID-19 vaccine for people 50 and older and certain immunocompromised individuals. View press release and media call.
Spikevax Information Fact Sheets and FAQs Fact Sheet Translations Información sobre las vacunas para el COVID-19
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