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. Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.
Moderna COVID-19 Vaccine is available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine.
The Moderna COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Pfizer-BioNTech COVID-19 Vaccine and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Moderna COVID-19 Vaccine.
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 |
Moderna COVID-19 Vaccine Fact Sheets (English) and FAQs
| Information | Last Updated |
|---|---|
| Fact Sheet for Healthcare Providers Administering Vaccine | January 31, 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 | January 31, 2022 |
| Frequently Asked Questions on the Moderna COVID-19 Vaccine | December 21, 2021 |
Moderna COVID-19 Vaccine Regulatory Information
| Information | Date |
|---|---|
| Letter of Authorization (Reissued) | January 31, 2022 |
| Decision Memorandum | January 6, 2021 |
| 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 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