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
| Information | Language |
|---|---|
| Letter of Authorization | English |
| Fact Sheet for Healthcare Providers Administering Vaccine | English |
| Fact Sheet for Recipients and Caregivers | English |
| FDA Decision Memorandum | English |
| Press Release | English |
| 12/17/2020 Advisory Committee Meeting Information | English |
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