12/21/2020, Moderna COVID-19 Vaccine(FDA)

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). 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:AuthorizedName:Moderna COVID-19 VaccineManufacturer: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.

Additional Information

InformationLanguage
Letter of AuthorizationEnglish
Fact Sheet for Healthcare Providers Administering VaccineEnglish
Fact Sheet for Recipients and CaregiversEnglish
FDA Decision MemorandumEnglish
Press ReleaseEnglish
12/17/2020 Advisory Committee Meeting InformationEnglish

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