The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
The FDA, yesterday, issued an EUA for the drug baricitinib (Olumiant), in combination with remdesivir (Veklury) for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. The safety and effectiveness of baricitinib for use in the treatment of COVID-19 continues to be evaluated. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission (FTC) to Pro Breath MD, LLC dba Dentist Select and OraCare for selling unapproved products with fraudulent COVID-19 claims. The company sells “OraCare Health Rinse” and “OraCare Operatory Pre-Rinsing Set” products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. FDA requested that Dentist Select and OraCare immediately stop selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
The FDA and the FTC also issued a joint warning letter to Vibrant Health Care, Inc., for marketing an unapproved umbilical cord derived cellular product to mitigate, prevent, treat, diagnose or cure COVID-19.
Today, the FDA announced it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer-BioNTech.
The agency also issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights on the agency's response efforts.
The FDA has updated a webpage, Vaccine Development – 101, to provide an overview of the vaccine development process.
In a new webpage, Emergency Use Authorization for Vaccines Explained, the FDA offers answers to questions about EUAs, in general, and more specifically, about EUA requests for a vaccine intended to prevent COVID-19.
Testing updates:
As of Nov 18, 289 tests are authorized by the FDA under EUAs; these include 224 molecular tests, 58 antibody tests, and 7 antigen tests.
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.
