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FDA gives full approval to Moderna COVID vaccine

The Moderna COVID vaccine was previously only available under emergency use authorization.

Published: January 31, 2022 5:13pm

Updated: January 31, 2022 5:42pm

The U.S. Food and Drug Administration on Monday gave full approval to the Moderna COVID-19 vaccine for people 18 and older.

"While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated," Acting FDA Commissioner Janet Woodcock said.

"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death," Moderna CEO Stéphane Bancel said. The company states that the Moderna COVID vaccine has received approval in more than 70 countries.

The booster Moderna vaccine is still only available under emergency use authorization (EUA).

The FDA explained in a press release that people who receive the shot have a higher risk of developing rare cases of heart inflammation, myocarditis and pericarditis, the benefits of the vaccine outweigh the risk.

The Moderna vaccine has been available under an EUA since Dec. 18, 2020. It is the second COVID vaccine to receive full FDA approval after the Pfizer-BioNTech vaccine.

Pfizer came under fire last month for continuing to distribute an earlier identical version of the vaccine that had only been approved under an EUA after the FDA gave the vaccine full approval, Just the News reported.

Federal and state health authorities state that vaccines and boosters keep most patients from developing serious cases of COVID-19 that lead to hospitalization and death.

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