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FDA Grants Full Approval of Moderna COVID-19 Vaccine
February 1, 2022
FDA Grants Full Approval of Moderna COVID-19 Vaccine
Yesterday, the U.S. Food and Drug Administration (FDA) granted full approval of the Moderna COVID-19 vaccine for people 18 years old and older. The vaccine will now be marketed as Spikevax for the prevention of COVID-19 disease. This is the second COVID-19 vaccine to receive full FDA licensure after meeting the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality required for approval. The Pfizer COVID-19 vaccine received this approval last August.
The Moderna COVID-19 vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020. Since then, more than 200 million doses of the Moderna vaccine have been administered in the United States, including more than 6.3 million doses administered in Ohio.
COVID-19 case rates and community spread remain extremely high across the state, and the Ohio Department of Health urges vaccine providers to take this opportunity to help build confidence among those who are vaccine hesitant. Please continue to share information about the safety and effectiveness of the vaccines, as both messenger RNA COVID-19 vaccines now have met the high standards for safety, effectiveness, and manufacturing quality required of any vaccine approved for use in the United States.