Showing posts with label COVID-19. Show all posts
Showing posts with label COVID-19. Show all posts

Saturday, December 19, 2020

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older."

Read the full news release:  FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

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Wednesday, December 16, 2020

FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov


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