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U.S. FDA authorizes Moderna’s COVID-19 vaccine for emergency use

U.S. FDA authorizes Moderna’s COVID-19 vaccine for emergency use

December 19, 2020

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Home News World

U.S. FDA authorizes Moderna’s COVID-19 vaccine for emergency use

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December 19, 2020
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U.S. FDA authorizes Moderna’s COVID-19 vaccine for emergency use
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Moderna Inc’s coronavirus vaccine on Friday became the second to receive emergency use authorization from the U.S. Food and Drug Administration (FDA), welcome news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost.

Millions of doses of the Moderna vaccine are expected to be added to the U.S. rollout, which began this week with healthcare workers. Older people in long-term care facilities are next in line for vaccines, with a U.S. Centers for Disease Control and Prevention expert panel on Sunday set to recommend what groups follow, as industries compete to have their workers given precedence.

The FDA announced the authorization the day after the agency’s panel of outside experts endorsed its use and a week after the FDA authorized a vaccine from Pfizer Inc and German partner BioNTech SE.

“The transparency around our review of the Moderna COVID-19 vaccine should assure the public that this vaccine met the FDA’s rigorous standards for quality, safety and efficacy. As with any decision made by the FDA, this authorization was guided solely by science and data,” FDA Commissioner Stephen M. Hahn, M.D, said in a late evening press conference

The vaccine from Pfizer and BioNTech, based on similar technology, has been put into the arms of thousands of U.S. healthcare workers this week in a massive nationwide rollout. Moderna injections are expected to begin in coming days for adults 18 years old and up.

The FDA also said it is investigating around five allergic reactions that happened after people were administered Pfizer Inc and BioNTech SE’s COVID-19 vaccine in the United States this week.Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the allergic reactions had been reported in more than one state, including in Alaska

Marks also said that a chemical called polyethylene glycol that is an ingredient in the Pfizer vaccine as well as the Moderna Inc vaccine authorized on Friday – “could be the culprit” causing the reactions.

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