- 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:
- On Friday, October 22, 2021, Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., discussed the FDA’s actions to expand the use of a single booster dose for COVID-19 vaccines in eligible populations. Specifically, they covered the use of a single booster dose of the Moderna and the Janssen (Johnson and Johnson) COVID-19 Vaccines, clarified the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for eligible individuals and covered the use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals. Health care professionals, patient advocacy groups, trade associations, consumer organizations, national immunization organizations and state and local public health organizations were invited to the call. To listen to the call, visit FDA’s YouTube channel.
- The FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new. The FDA has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the United States. The FDA recommends that health care facilities and providers do not purchase or use imported medical gloves from companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves and report any problem with medical gloves.
- The FDA authorized the 11th over-the-counter (OTC) COVID-19 test. The FDA is committed to increasing the availability of accurate and reliable at-home COVID-19 diagnostic tests and to facilitating consumer access to these tests. The FDA issued an emergency use authorization (EUA) for the Detect Covid-19 Test, an OTC COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour.
The test can be used as:
- A single test for people with COVID-19 symptoms.
- A serial test for people without symptoms. A serial test means the test is done two times over three days.
The test can be used for people:
- Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years and older when an adult collects the nasal swab sample.
- Testing updates:
- As of today, 421 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests and 38 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, nine EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 16 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 667 revisions to EUA authorizations.
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.
- Shirley Simson