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HHS and DOD statements on FDA authorization of Moderna vaccine

Image of Image with documents and vaccine products laying on table. A display shows items that will be provided with COVID-19 vaccines at Operation Warp Speed headquarters in Washington, D.C., Nov. 13, 2020. Operation Warp Speed is an effort by several U.S. government components and public partnerships to facilitate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. (Photo by EJ Hersom, Department of Defense.)

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On Friday, Dec. 18, the Food and Drug Administration announced that it had issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, the second COVID-19 vaccine to receive an EUA. Operation Warp Speed has allocated more than 5.9 million doses of the vaccine for jurisdictions to receive in the coming week.

“On January 7, before China had reported even one death from the novel coronavirus or confirmed human-to-human transmission, NIH scientists and innovators at Moderna agreed to begin work on the vaccine that received FDA authorization today,” according to Health and Human Services Secretary Alex Azar in a prepared statement.

“In March, BARDA scientists joined the partnership and worked with Moderna and NIH to reach commercialization, building on support BARDA has provided since 2016 for the remarkable mRNA technology. To have two vaccines against a novel virus authorized and distributed within a year is extraordinary, and to have one of these vaccines developed by scientists at the NIH should be a great source of pride for every member of the HHS family and every American,” he added.

“The swift authorization of a second vaccine by the FDA is great news for the American people,” acting secretary of defense Christopher Miller stated. “The DoD, with the work of General Perna and Operation Warp Speed, stands ready to work with our public and private-sector partners to ensure doses reach Americans as soon as possible.

“The public-private partnership of Operation Warp Speed has helped Moderna, an American startup, become one of the first two companies to receive FDA authorization for a COVID-19 vaccine,” Azar explained. “Authorization of Moderna’s vaccine means we can accelerate the vaccination of frontline healthcare workers and Americans in long-term-care facilities, and, ultimately, bring a faster end to this pandemic.”

“Together, we will bring this pandemic to an end,” concluded Miller.

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