The U.S. Food and Drug Administration (FDA) has granted full approval of the Moderna COVID-19 vaccine for individuals 18 years of age and older.
Samroz Jakvani, the Jefferson County Health Department’s epidemiologist, said the vaccine will now be marketed as Spikevax.
In August 2021, the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine was the first COVID-19 vaccine to receive full approval from the FDA and is available for individuals aged 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine is also available for individuals aged 5 and older under emergency use authorization (EUA).
Jakvani said that in order to grant full approval, the FDA required extensive data on safety and effectiveness, inspection of manufacturing facilities, and a comprehensive review of all clinical and real-world use.
The full approval means that additional data was gathered and analyzed following the grant of emergency use authorization in December 2020 to further confirm that this vaccine works and is safe. “All of the COVID-19 vaccines are extremely effective at preventing serious illness, hospitalization, and death – including from the Delta and Omicron variants,” Jakvani stated in a news release.
He said the vaccine also continues to be available under an EUA for the administration of a third dose in certain individuals who are immunocompromised.
The FDA-approved Moderna product Spikevax (COVID-19 vaccine, mRNA) and the FDA-authorized Moderna COVID-19 vaccine under emergency use authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.
“Getting vaccinated for COVID-19 is the best way to protect yourself and others around you,” Jakvani said. The Jefferson County Health Department is administering the COVID-19 vaccine at the health department Monday through Friday by appointment only. Appointments can be made by calling 920-674-7275.
To find a COVID-19 vaccination site, visit www.vaccines.gov, text your Zip code to 438829, or call 211. You can also call 844-684-1064 or 800-232-0233.
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