Coronavirus (COVID-19) Update: January 8, 2021 | site |

(The following is part of the information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021)

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
  • The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
    • Details on the effect of genetic variants on test performance.
    • Recommendations for clinical laboratory staff and health care providers.
    • Actions the FDA has taken.
    • Instructions for reporting problems with a test.
  • This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA review when deciding whether to authorize the vaccine for emergency use, how well the vaccine prevents COVID-19, and more.
  • Testing updates:
    • As of today, 311 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 235 molecular tests and sample collection devices, 64 antibody tests, and 12 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.