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Source: AP Photo/Taimy Alvarez
On Tuesday the Food and Drug Administration issued an emergency use authorization for the first over-the-counter fully at-home COVID-19 diagnostic test. The Ellume COVID-19 Home Test is a nasal swab that can be taken by anyone 2 years or older. It is the first COVID test that can be used completely at home without a prescription, the FDA explains. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product, when used for diagnosing COVID-19, outweigh the known and potential risks of such product, FDA Chief Scientist Denise M. Hinton wrote in a letter to Ellume Limited s Myriam Battistutta.
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BY: ANNE FLAHERTY, SONY SALZMAN AND ERIC M. STRAUSS, ABC NEWS
(NEW YORK) The Food and Drug Administration authorized the United States’ first COVID-19 vaccine for people age 16 and over late Friday, a historic moment in a pandemic that has killed over 290,000 in this nation and nearly 1.6 million people worldwide.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Dr. Stephen Hahn, said in a statement.
The emergency use authorization was expected to trigger the first shipment of 2.9 million doses to 636 sites across the country within 24 hours, primarily to hospitals where front-line health care workers are expected to receive them. Nursing homes and other long-term care facilities are also considered a top priority.
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