Moderna COVID-19 Vaccines
Spikevax, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent
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 as a single booster dose to prevent COVID-19, administered at least 2 months after:
- Completion of primary vaccination with the monovalent Moderna COVID-19 Vaccine in children 6 months through 5 years of age, or
- Completion of primary vaccination with any authorized or approved COVID-19 vaccine in individuals 6 years of age and older, or
- Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine in individuals 6 years of age and older.
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) | April 19, 2022 |
| CDC-issued Emergency Use Instructions | February 11, 2022 |
Moderna COVID-19 Vaccine Fact Sheets (English)
Health Care Provider Materials
| Material | Vaccine Purpose | Vaccine Recipient Group | Last Updated |
|---|---|---|---|
| Fact Sheet | Primary Series | 6 months through 5 years of age (magenta border) | December 8, 2022 |
| Fact Sheet | Bivalent Booster | 6 months through 5 years of age (yellow border) | December 8, 2022 |
| Fact Sheet | Primary Series | 6 years through 11 years of age (purple and teal border) | December 8, 2022 |
| Fact Sheet | Primary Series | 12 years and older (light blue border) | December 8, 2022 |
| Fact Sheet | Bivalent Booster | 6 years and older (gray border) | December 8, 2022 |
| Dear Healthcare Provider Letter | Bivalent Booster | 6 months through 5 years (dark pink cap and label with yellow box) | December 8, 2022 |
| Dear Healthcare Provider Letter | Bivalent Booster | 6 years and older (blue cap and gray border) | October 12, 2022 |
| Dear Healthcare Provider Letter | Bivalent Booster | 18 years and older (gray border) | September 7, 2022 |
| Important Prescribing Information for Vaccine Providers on Vial Presentation Available to Provide Doses for Ages 6 Years Through 11 Years | Primary Series | 6 years through 11 years of age (purple border) | August 31, 2022 |
| Moderna COVID-19 Vaccine Presentations Wall Chart | Primary Series and Booster | 6 months of age and older | March 12, 2023 |
Recipient and Caregiver Materials
| Material | Vaccine Purpose | Vaccine Recipient Group | Last Updated |
|---|---|---|---|
| Fact Sheet | Primary Series and Bivalent Booster | 6 months through 5 years of age | December 8, 2022 |
| Fact Sheet | Primary Series and Bivalent Booster | 6 years and older | December 8, 2022 |
Moderna COVID-19 Vaccine Regulatory Information
Media Materials and Webcasts
| Information | Date |
|---|---|
| Press Release | December 8, 2022 |
| Press Release | October 12, 2022 |
| Press Conference | August 31, 2022 |
| Press Release | August 31, 2022 |
| 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 Moderna Fact Sheet for Recipients and Caregivers for 6 months through 5 years of age
| Fact Sheet | Vaccine Recipient Group | Language |
|---|---|---|
|
HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES AUTORIZACIÓN DE USO DE EMERGENCIA DE LA VACUNA CONTRA EL COVID-19 DE MODERNA PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) EN NIÑOS DE 6 MESES A 5 AÑOS |
6 months - 5 years of age | Español (Spanish) |
|
给受种人和监护人的情况说明书 针对6 个月到 5 岁的个体 预防 2019冠状病毒病 (COVID-19) 的现代 COVID-19 疫苗紧急使用授权 |
6 months - 5 years of age | 中文 (Chinese, Simplified) |
|
수혜자와 간병인을 위한 팩트 시트 6개월에서 5세 사이의 개인에 코로나 바이러스 질병 2019(COVID-19)를 예방하기 위한 모더나 COVID-19 백신의 긴급 사용 승인 |
6 months - 5 years of age | 한국어 (Korean) |
|
FACT SHEET PARA SA MGA TATANGGAP AT MGA NAG-AALAGA EMERGENCY USE AUTHORIZATION NG BAKUNANG MODERNA COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) SA MGA INDIBIDWAL 6 NA BUWAN HANGGANG 5 TAONG GULANG |
6 months - 5 years of age | Tagalog (Tagalog) |
| 6 months - 5 years of age | Tiếng Việt (Vietnamese) |
Translations of the Moderna Fact Sheet for Recipients and Caregivers for 6 through 11 years of age
| Fact Sheet | Vaccine Recipient Group | Language |
|---|---|---|
|
HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES AUTORIZACIÓN DE USO DE EMERGENCIA DE LA VACUNA CONTRA EL COVID-19 DE MODERNA PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) EN NIÑOS DE 6 AÑOS A 11 AÑOS |
6 - 11 years of age | Español (Spanish) |
|
给受种人和监护人的情况说明书 针对6 岁到 11 岁个体 预防 2019 冠状病毒病 (COVID-19) 的现代 COVID-19 疫苗紧急使用授权 |
6 - 11 years of age | 中文 (Chinese, Simplified) |
|
수혜자와 간병인을 위한 팩트 시트 6세에서 11세 사이의 개인에 코로나 바이러스 질병 2019(COVID-19)를 예방하기 위한 모더나 COVID-19 백신의 긴급 사용 승인 |
6 - 11 years of age | 한국어 (Korean) |
|
FACT SHEET PARA SA MGA TATANGGAP AT MGA NAG-AALAGA EMERGENCY USE AUTHORIZATION NG BAKUNANG MODERNA COVID-19 UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) SA MGA 6 NA TAON HANGGANG 11 TAONG GULANG |
6 - 11 years of age | Tagalog (Tagalog) |
| 6 -11 years of age | Tiếng Việt (Vietnamese) |
Translations of the Moderna Fact Sheet for Recipients and Caregivers for 12 years of age and older
Translations of the Moderna Fact Sheet for Recipients and Caregivers 6 years of age and older