- For immediate release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response to the COVID-19 pandemic:
- On Friday, October 22, the FDA announced that it found two batches of Astra Zeneca COVID-19 vaccine drug, manufactured at its Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the US, but the FDA understands that these AstraZeneca lots, or vaccines made from the batches, may be exported for use. The agency conducted a thorough review of the facility records and the results of quality testing conducted by the manufacturer and made its decision based on this review, taking into account the current global COVID-19 public health emergency. To read the advice letter and the decision note, please visit the Biologics Electronic Reading Room.
- The FDA has re-issued an Emergency Use Authorization (EUA) for the OraSure Technologies InteliSwab COVID-19 Rapid Test. The InteliSwab COVID-19 Rapid Test gives results in 30 minutes and can be used:
- Without a prescription.
- As a one-time test for people with COVID-19 symptoms.
- As a serial test for people without COVID-19 symptoms, when the test is performed twice over three days with a minimum of 24 hours (and no more than 48 hours) between tests.
- For people 18 years and older with a self-collected nasal swab or people 15 years and older when an adult takes the nasal swab.
The FDA has reissued the EUA to allow the use of InteliSwab COVID-19 Rapid Test as a single over-the-counter test for people with COVID-19 symptoms. The test had already been approved for use as a serial over-the-counter test by people with or without COVID-19 symptoms and as a single-use prescription test for symptomatic people suspected of having COVID-19 by their healthcare provider.
The FDA is committed to helping increase the availability of accurate and reliable home COVID-19 diagnostic tests and facilitating consumer access to these tests.
- The FDA recently reviewed several outpatient research contracts in the Medical Countermeasures Initiative (MCMi) Regulatory Science Program to expand efforts to support the development of medical countermeasures against COVID-19. The FDA has updated contracts including:
- University of Liverpool, to better understand how COVID-19 develops and its severity, including for variants of concern, such as the Delta variant;
- Stanford University, to identify biomarkers and immune correlates of protection to better understand the different responses of populations, including race, ethnicity, gender and age, to aid the development and evaluation of medical countermeasures for all; and
- Wyss Institute for Biologically Inspired Engineering at Harvard University, to develop novel organs-on-chips to support the development and testing of countermeasures for COVID-19.
- Testing updates:
- As of today, 421 tests and sample collection devices have been approved by the FDA under Emergency Approvals (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 self-collected samples. There is one EUA for a home molecular prescription test, three EUAs for home prescription antigen testing, nine EUA for self-testing for antigen over-the-counter (OTC) and three EUAs for OTC home molecular testing.
- The FDA has approved 16 antigen tests and nine molecular tests for serial screening programs. The FDA has also approved 672 revisions to test EUA authorizations.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.