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  1. Coronavirus Disease 2019 (COVID-19)

Moderna COVID-19 Vaccine

January 7, 2022: FDA shortens interval for booster dose of Moderna COVID-19 Vaccine to five months. Read the press release or view booster eligibility.

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.


 
Emergency Use Authorization Status:
Authorized
Name:
Moderna COVID-19 Vaccine
Manufacturer:
ModernaTX, Inc.

Authorized Use

For the prevention of 2019 coronavirus disease (COVID-19) for individuals 18 years of age and older

Common Side Effects

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Learn more.

Fact Sheets (English) and FAQs

Regulatory Information

Information Date
Letter of Authorization (Reissued) January 7, 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 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
 

接种者和护理者须知 莫德纳2019年新冠肺炎疫苗用于18岁及以上人群的紧急使用授权
(December 9, 2021)
  中文 (Chinese)

صفحھ معلومات واکسین برای دریافت کننده گان و مراقبت کننده گا ن
مجوز استفاده اضطراری ا ز واکسین کووید- ۱۹ مدرنا برای جلوگیری از مرض ویروس کرونا ۲۰۱۹
(کووید- ۱۹ ) در افراد ۱۸ سال و بالاتر از آن

(December 9, 2021)

 
دری, (Dari)

បញ្ជ ីហេតុការណស ការអ្នុញ្ញា  តឲ្យហម្របើម្រាសជា់ ម្រាប់អ្នកទទលនិងអ្នកថែរទាំបន្ទា  ន់(EUA) ននវ៉ា កស់     ាំងម៉ូ ៉ាថែណាក៉ូ វដ19 (MODERNA COVID-19)ហដមបីបង្កា  រជមងឺករណា៉ា 2019(COVID-19)សម្រាប់បុគ្លាន  ក់ៗថដលានអាយុចាប់ពី18 ឆ្ន ាំហឡើងហៅ

(December 9, 2021)

  ភាសាអង់គ្លេស (Khmer)
환자와 의료진을 위한 정보지 18세 이상의 사람들에게서 코로나바이러스감염증 2019 (COVID-19)를 예방하기 위한 모더나 (MODERNA) 백신의 긴급사용승인
(December 9, 2021) 
  한국어 (Korean)

FYÈ ENFÒMASYON POU RECIPÈ AK MOUN K’AP PRAN SWEN SANTE OTORIZASYON ITILIZASYON IJANS (EUA) POU VAKSEN MODERNA COVID-19 POU ANPECHE MALADI CORONAVIRUS 2019 (COVID-19) NAN MOUN KI GEN 18 ANS AK PLIS

(December 9, 2021)

  Kreyòl Ayisyen (Haitian Creole)

DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU KEV PAB THIAB COV NEEG ZOV TU KEV TSO CAI SIV THAUM KUB CEEV (EMERGENCY USE AUTHORIZATION) (EUA) QHOV TSHUAJ TIV THAIV KAB MOB MODERNA COVID-19 LOS TIV THAIV TUS KAB MOB CORONAVIRUS 2019 (COVID-19) RAU COV TIB NEEG MUAJ 18 XYOOS THIAB LAUS DUA
(December 9, 2021)

  Hmoob (Hmong)
FICHA TÉCNICA PARA RECEPTORES E CUIDADORES AUTORIZAÇÃO DE USO EMERGENCIAL (AUE) DA VACINA MODERNA COVID-19 PARA EVITAR A DOENÇA POR CORONAVÍRUS 2019 (COVID-19) EM INDIVÍDUOS MAIORES DE 18 ANOS
(December 9, 2021)
  Português (Portuguese)
ИНФОРМАЦИОННЫЙ БЮЛЛЕТЕНЬ ДЛЯ РЕЦИПИЕНТОВ И СПЕЦИАЛИСТОВ ПО УХОДУ РАЗРЕШЕНИЕ НА ЭКСТРЕННОЕ ПРИМЕНЕНИЕ (EUA)ВАКЦИНЫ MODERNA COVID-19 ДЛЯ ПРЕДОТВРАЩЕНИЯ ЗАБОЛЕВАНИЯ КОРОНАВИРУСНОЙ ИНФЕКЦИЕЙ 2019 (COVID-19) У ЛИЦ В ВОЗРАСТЕ 18 ЛЕТ И СТАРШЕ
(December 9, 2021)
  Русский (Russian)
HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES AUTORIZACIÓN DE USO DE EMERGENCIA (EUA) DE LA VACUNA CONTRA EL COVID-19 DE MODERNA PARA PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) EN PERSONAS DE 18 AÑOS O MÁS
(December 9, 2021)
  Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) NG MODERNA COVID-19 VACCINE UPANG MAIWASAN ANG SAKIT SA CORONAVIRUS 2019 (COVID-19) SA MGA INDIBIDWAL 18 TAONG GULANG AT PATAAS
(December 9, 2021)/media-base/144712
  Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC CHO PHÉP SỬ DỤNG KHẨN CẤP (EUA) VHO PHÉP SỬ DỤNG KHẨN CẤP (EUA)NHỮNG NGƯỜI CHĂM SÓC􀀀RUS 2019 (COVID-19) N CẤP (EUA)NHỮNG NGƯỜI CHĂM
(December 9, 2021)
  Tiếng Việt (Vietnamese)
FACT SHEET PARA SA MGA TATANGGAP AT CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) NG MODERNA COVID-19 VACCINE UPANG MAIWASAN ANG SAKIT SA CORONAVIRUS 2019 (COVID-19) SA MGA INDIBIDWAL 18 TAONG GULANG AT PATAAS
(December 9, 2021)
  Uzbeck(Uzbeck)

 

 

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