RSV Injection for Infants Approved

FDA Issues Authorization for Use of Moderna’s COVID-19 Vaccine

On December 18th 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the second vaccine for the prevention of COVID-19.

FDA scientists found the Moderna vaccine to be “safe and efficacious,” prompting the FDA’s determination that the Moderna vaccine has met the statutory criteria for issuance of an EUA. Specifically, studies found the vaccine to be 94% effective at preventing symptomatic illness and spreading COVID-19. The data also shows that the known and potential benefits outweigh the known and potential risks, ultimately supporting the company’s request for the vaccine’s use in people 18 years of age and older.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day.”

FDA Commissioner, Stephen M. Hahn

As the FDA continues to collect safety data on the vaccine before issuing full approval, the U.S. government ordered 100 million doses of the vaccine, which will be delivered in shipments throughout the remainder of this year and the first quarter of 2021. According to Moderna, 20 million doses are being prepared to be delivered by the end of December 2020.

This endorsement follows the approval of Pfizer Inc.’s COVID-19 vaccine, which received an EUA on December 11, 2020 and began vaccinations to healthcare workers and long-term care residents on December 14, 2020.

The approved COVID-19 vaccine will likely still require months before distribution reaches the general public. Organizations should plan for the coronavirus pandemic to continue and await more guidance for what vaccine authorization will mean for workplaces. In the meantime, follow the CDC’s recommendations to keep yourself and those around you safe and healthy.

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