- 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, Friday, November 5, 2021, the FDA authorized another over-the-counter (OTC) COVID-19 test. The FDA issued an emergency use authorization (EUA) for the iHealth COVID-19 Antigen Rapid Test, an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. The company anticipates producing 100 million tests per month, with capacity increasing to 200 million per month in early 2022.
- The test can be used as:
- A single test for people with COVID-19 symptoms.
- A serial test for people without symptoms, meaning the test is done two times over three days.
- The test can be used for people:
- Age 15 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
- The FDA is committed to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating consumer access to these tests.
- The test can be used as:
- Today, Friday, November 5, 2021, the FDA authorized the use, under the EUA for the Janssen COVID-19 Vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility. To date, a total of eleven batches of Janssen COVID-19 vaccine that were manufactured at the Emergent facility have been authorized. The FDA conducted a thorough review of facility records and quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues on this matter with Janssen and Emergent BioSolutions management.
- On November 1, 2021, the FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2 from BioFire Defense, LLC. The test, which has been offered under an EUA since March 2020, is the second SARS-CoV-2 diagnostic test granted marketing authorization that permits the test to be marketed beyond the public health emergency.
The BioFire COVID-19 Test 2:
- Is a molecular diagnostic test.
- Detects SARS-CoV-2 in nasopharyngeal swab samples, where the sample is taken from deep inside the nose, reaching the back of the throat.
- Is for people with symptoms who are suspected of COVID-19 by their health care provider.
- On Monday, November 1, 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 EUA of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age. 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 watch the video, visit the FDA’s YouTube channel.
- Testing updates:
- As of today, 419 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 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 677 revisions to test 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.
- Jeremy Kahn