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  1. Coronavirus Disease 2019 (COVID-19)

Moderna COVID-19 Vaccine

October 20, 2021: The FDA expands authorizations for COVID-19 vaccine booster doses for eligible populations who received the Pfizer-BioNTech or Moderna COVID-19 Vaccine and for Janssen COVID-19 Vaccine recipients 18 and older.  View more information and listen to the media call.

On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.

On August 12, 2021, the FDA amended the Moderna COVID-19 Vaccine EUA to allow for an additional dose to be given to certain immunocompromised individuals.

On October 20, 2021, the FDA amended the Moderna COVID-19 Vaccine EUA to allow for a single booster dose of the Moderna COVID-19 Vaccine administered at least 6 months after completion of the primary series to individuals:

  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID-19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

The Moderna COVID-19 single booster dose is half of the dose administered for a primary series dose. Also on October 20, 2021, the FDA authorized the use of a heterologous (or “mix and match”) booster dose for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Therefore, Moderna COVID-19 Vaccine recipients falling into one of the authorized categories for boosters may receive a booster dose of Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine at least six months after completing their primary vaccination.

The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.


 
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) October 20, 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 October 20, 2021
Media Call October 20, 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

At this time, the FDA is able to provide translations of the Moderna COVID-19 Vaccine Fact Sheets for Recipients and Caregivers in the languages below. If you have a special language request, please contact: fdaoma@fda.hhs.gov.

供接受疫苗者和照顾者使用的情况说明书
(August 27, 2021)
中文 (Chinese)
환자와 의료진을 위한 정보지
(August 27, 2021)
한국어 (Korean)
HOJA INFORMATIVA PARA RECEPTORES Y CUIDADORES
(August 27, 2021)
Español (Spanish)
FACT SHEET PARA SA MGA TUMATANGGAP AT TAGAPAG-ALAGA
(August 27, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN DÀNH CHO NGƯỜI ĐƯỢC TIÊM VẮC-XIN VÀ NGƯỜI CHĂM SÓC
(August 27, 2021)
Tiếng Việt (Vietnamese)
QABUL QILISHCHILAR VA VASIYLAR UCHUN FACTLAR
(August 27, 2021)
Uzbeck(Uzbeck)

 

 

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