Moderna COVID-19 Vaccine
August 18, 2021: FDA supports the Administration’s work to plan for the deployment of additional vaccine doses, or boosters, this fall. FDA will undertake an independent scientific evaluation of the safety and effectiveness of boosters for each vaccine. View joint statement.
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. 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
| Information | Last Updated |
|---|---|
| Fact Sheet for Healthcare Providers Administering Vaccine | August 27, 2021 |
| Fact Sheet for Recipients and Caregivers | August 27, 2021 |
| Frequently Asked Questions on the Moderna COVID-19 Vaccine | August 12, 2021 |
Regulatory Information
| Information | Date |
|---|---|
| Letter Granting EUA Amendment | August 30, 2021 |
| Letter of Authorization (Reissued) | August 12, 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 | 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 Fact Sheet for Healthcare Providers Administering Vaccine
| Fact Sheet | Language |
|---|---|
| ورقة ح قائق لمقدمي الرع ایة ال ص ح یة القائم ین ع لى ح قن اللقاح (مقدمي خ دمة التلقیح ) (December 2020) |
عربي (Arabic) |
| 供提供疫苗接种的医务人员（疫苗接种提供者）使用的情况说明书 (December 2020) |
中文 (Chinese) |
| FEUILLET D’INFORMATION POUR LES PROFESSIONNELS DE LA SANTÉ ADMINISTRANT LE VACCIN (VACCINATEURS) (December 2020) |
Français (French Canadian) |
| HOJA INFORMATIVA PARA PROVEEDORES DE ATENCIÓN MÉDICA QUE ADMINISTRAN VACUNAS (PROVEEDORES DE VACUNACIÓN) (June 25, 2021) |
Español (Spanish) |
| FACT SHEET PARA SA MGA HEALTHCARE PROVIDER NA NAGLALAPAT NG BAKUNA (MGA TAGAPAGBIGAY NG PAGBABAKUNA) (December 2020) |
Tagalog (Tagalog) |
| TỜ THÔNG TIN DÀNH CHO CHUYÊN GIA CHĂM SÓC SỨC KHOẺ TIÊM VẮC-XIN (CHUYÊN GIA TIÊM CHỦNG) (December 2020) |
Tiếng Việt (Vietnamese) |