- For immediate release:
The Food and Drug Administration today announced the following actions taken in its ongoing effort to respond to the COVID-19 pandemic:
- This week, the FDA published the website, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biological Research and Evaluation is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs and other academic and health data systems. large non-governmental organizations.
- This week, the FDA issued an emergency use authorization (USA) for a combination of monoclonal antibodies for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age or older and weighing at least 40 kg) [about 88 pounds]) with a positive test for SARS-CoV-2 and with a high risk of progression to severe COVID-19.
- This week, the FDA revised its guidance, Investigational COVID-19 Convalescent Plasma and the associated web page, to reflect the reissued Emergency Use Authorization for COVID-19 convalescent plasma. Specifically, the guide provides recommendations to blood establishments on the collection and labeling of high-quality COVID-19 convalescent plasma under the US. In addition, the reviews address when individuals who received experimental COVID-19 monoclonal therapy as participants in a clinical trial, or received authorized or licensed monoclonal antibody therapy COVID-19, qualify as convalescent plasma donors.
- Testing updates:
- As of today, 327 tests and sample collection devices are authorized by the FDA under emergency use authorization (EUAs). This includes 243 molecular tests and sample collection devices, 70 antibody tests and 14 antigen tests. There are 35 molecular permits that can be used with samples collected at home. There is a home molecular prescription test, a home test with antigen prescription and an over-the-counter home antigen test (OTC).
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.
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