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 |
|---|---|
| Decision Memorandum | June 17, 2022 |
| 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
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