Moderna Emergency Use Authorization And FDA Approval
An Emergency Use Authorization (EUA) for COVID-19 vaccine (Moderna) was issued by the Food and Drug Administration (FDA) on December 18, 2020. FDA granted full approval for primary (2-dose) series of the Moderna COVID-19 (Spikevax) Vaccine for persons 18 years of age and older on January 31, 2022.
An EUA allows access to critical medical products that may help during a public health emergency. EUAs differ from approval/licensure in they are authorized to use for a serious or life-threatening disease or condition and there is no adequate FDA-approved alternative. Approval/licensure means vaccines have received full approval for use after additional data has been reviewed.
The Spikevax Vaccine is available under approval/licensure for a primary (2-dose) series for people 18 years of age and older.
The Moderna Vaccine is available under EUA for:
- People 18 years of age and older who are moderately or severely immunocompromised for an additional primary (3rd) dose
- People 18 years of age and older for a booster dose