- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to discuss the Emergency Use Authorization (EUA) request from Janssen Biotech Inc. for its COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Meeting materials are available on the FDA’s webpage. An archived link to the meeting webcast can be found here.
- Today, the FDA added new devices to the device discontinuance list, including sterilization products and oxygen conservers. There are no updates to the device shortage list at this time. The FDA will continue to update the device discontinuance and device shortage lists as the COVID-19 public health emergency evolves.
- The FDA’s Office of Medical Policy within the Center for Drug Evaluation and Research presented about the role of the CURE Drug Repurposing Collaboratory (CRDC) in drug repurposing for neglected tropical diseases as well as COVID-19 at an International Society of Neglected Tropical Diseases online conference on February 24. The CRDC is a public-private partnership among C-Path, FDA and the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health. The CDRC is designed to capture real-world clinical outcome data to advance drug repurposing and inform future clinical trials for diseases of high unmet medical need.
- The FDA continues to warn consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested. The agency has discovered that some hand sanitizers are being packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles. Manufacturers should be vigilant about avoiding packaging and marketing their hand sanitizers in containers resembling food or drink packages in an effort to mitigate any potential inadvertent use by consumers. The agency added some of these products to the do not use list of hand sanitizers and urges consumers to be cautious of hand sanitizer packaging. Hand sanitizer can be toxic when ingested. Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer. The FDA continues to monitor these products and will take appropriate actions as needed to protect the health of Americans.
- The FDA published a new web page, COVID-19 Vaccination & the Food and Agriculture Sector, to share information and resources to help employers in the Food and Agriculture sector communicate about COVID-19 vaccination to their workforce. The resources are from the FDA, the Centers for Disease Control and Prevention (CDC), and other trusted partners. Constituent Update: FDA Shares Resources for the Food and Agriculture Sector about COVID-19 Vaccination
- Testing updates:
- As of today, 332 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 248 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 37 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.
- Jeremy Kahn