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  1. Coronavirus Disease 2019 (COVID-19)

Moderna COVID-19 Vaccines

Spikevax and 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 in individuals 18 years of age and older as a single booster dose administered at least 2 months after either: 

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or 
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

In consultation with FDA, CDC issues 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) April 19, 2022
CDC-issued Emergency Use Instructions February 11, 2022

Moderna COVID-19 Vaccine Fact Sheets (English) and FAQs

Material Audience Vaccine Purpose Vaccine Recipient Group Last Updated
Moderna COVID-19 Vaccine Presentations Wall Chart Healthcare Providers Bivalent Booster All August 31, 2022
Dear Healthcare Provider Letter Healthcare Providers 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 Healthcare Providers Primary Series 6 years through 11 years of age (purple border) August 31, 2022
Fact Sheet Healthcare Providers Primary Series 6 months through 5 years of age (magenta border) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series 6 months through 5 years of age (magenta border) June 17, 2022
Fact Sheet Healthcare Providers Primary Series 6 years through 11 years of age (teal and purple border) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series 6 years through 11 years of age (teal & purple border) June 17, 2022
Fact Sheet Healthcare Providers Primary Series 12 years and older (light blue border) August 31, 2022
Fact Sheet Healthcare Providers Bivalent Booster 18 years and older (gray border) August 31, 2022
Fact Sheet Recipients and Caregivers Primary Series and Bivalent Booster 12 years and older (primary series) and 18 years and older (booster) (black border) August 31, 2022
Frequently Asked Questions on the Moderna COVID-19 Vaccine All All All February 16, 2022
 

Moderna COVID-19 Vaccine Regulatory Information

Information Date
Concurrence Letter October 6, 2022
Decision Memorandum Addendum #2 September 28, 2022
Concurrence Letter September 28, 2022
Decision Memorandum Addendum September 26, 2022
Concurrence Letter September 26, 2022
Decision Memorandum September 20, 2022
Concurrence Letter September 20, 2022
Decision Memorandum August 31, 2022
Letter of Authorization (Reissued) August 31, 2022
Decision Memorandum 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 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 Fact Sheet for Recipients and Caregivers
 

 

Translations of the Moderna Fact Sheet for Recipients and Caregivers for 6 months through 5 years of age
 

Translations of the Moderna Fact Sheet for Recipients and Caregivers for 6 through 11 years of age
 

Translations of the Moderna Fact Sheet for Recipients and Caregivers for 12 years of age and older

Fact Sheet Vaccine Recipient Group Language
HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES SOBRE LAS VACUNAS SPIKEVAX (VACUNA DE ARNm CONTRA EL COVID-19) Y LA VACUNA CONTRA EL COVID-19 DE MODERNA PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) EN PERSONAS DE 12 AÑOS Y MAYORES
(August 31, 2022) 
12 years of age and older Español (Spanish)
疫苗接种者和护理者须知 关于SPIKEVAX(2019新冠肺炎疫苗,mRNA)和莫德纳2019新冠肺炎疫苗在12岁及以上个体中预防2019新型冠状病毒疾病(COVID-19)
(August 31, 2022) 
12 years of age and older 中文 (Chinese, Simplified)
환자와 의료진을 위한 정보지 12세 이상의 사람들에게서 코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한 스파이크백스 (코비드-19, 메신저 RNA)와 모더나 (MODERNA) 백신의 긴급사용승인
(August 31, 2022) 
12 years of age and older 한국어 (Korean)
FACT SHEET NG IMPORMASYON SA BAKUNA PARA SA MGA TATANGGAP AT TAGAPAG-ALAGA TUNGKOL SA SPIKEVAX (COVID-19 VACCINE, mRNA) AT ANG MODERNA COVID-19 VACCINE UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-19) SA MGA INDIBIDWAL NA 12 TAONG GULANG AT PATAAS
(August 31, 2022) 
12 years of age and older Tagalog (Tagalog)
TỜ THÔNG TIN VỀ VẮC XIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC GIỚI THIỆU VỀ SPIKEVAX (COVID-19 VẮC XIN, mRNA) VÀ MODERNA COVID-19 VẮC XIN ĐỂ PHÒNG NGỪA BỆNH CORONAVIRUS 2019 (COVID-19) Ở CÁC CÁ NHÂN 12 TUỔI TRỞ LÊN
(August 31, 2022) 
12 years of age and older Tiếng Việt (Vietnamese)

 

 

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