On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Moderna COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
Moderna COVID-19 Vaccine is available under EUA as a two-dose primary series in 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 in people 18 years of age and older.
The Moderna COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) booster dose 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:
- Moderna COVID-19 Vaccine
- ModernaTX, Inc.
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
|Fact Sheet for Healthcare Providers Administering Vaccine||November 19, 2021|
|Important prescribing information for vaccine providers on booster dose volume (0.25mL) and vial presentation||October 21, 2021|
|Fact Sheet for Recipients and Caregivers||November 19, 2021|
|Frequently Asked Questions on the Moderna COVID-19 Vaccine||October 4, 2021|
|Decision Memorandum||November 19, 2021|
|Decision Memorandum Addendum||November 19, 2021|
|Letter of Authorization (Reissued)||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
|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