Coronavirus (COVID-19) Update: March 2, 2021 | site |



(Information contained in U.S. Food and Drug Administration press release dated: March 2, 2021)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
  • The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
  • The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home use with a self-collected nasal swab sample by people age 14 years and older or people age 8 years and older, when the nasal swab sample is collected by an adult, within the first six days of the onset of COVID-19 symptoms.
  • A new FDA Voices entitled National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams, by Judy McMeekin, Pharm. D., explains that the FDA is on the lookout for charlatans seeking to profit from the pandemic. Vaccine distribution is underway throughout the country and schemes to mislead and scam the American public are prevalent. Public health protection for consumers is the hallmark of our mission and the FDA remains vigilant to ensure that consumers are shielded from seedy efforts and can have confidence in COVID-19 vaccines.
  • Testing updates:
As of today, 335 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 249 molecular tests and sample collection devices, 71 antibody tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test and one over-the-counter (OTC) at-home antigen test.