 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, the FDA announced that it found two lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but the FDA understands that these AstraZeneca lots, or vaccine made from the lots, may be exported for use. The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency. To read the advice letter and decision memo, please visit the Biologics Electronic Reading Room.
- The FDA reissued 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 single 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 at least 24 hours (and no more than 48 hours) between tests.
- For people 18 years of age and older with a self-collected nasal swab sample or people 15 years of age and older when an adult collects the nasal swab sample.
The FDA reissued the EUA to authorize use of InteliSwab COVID-19 Rapid Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms and as a single use test with a prescription for symptomatic people who are suspected of COVID-19 by their healthcare provider.
The FDA is committed to helping increase the availability of accurate and reliable at-home COVID-19 diagnostic tests, and to facilitating consumer access to these tests. - The FDA recently revised several extramural research contracts in the Medical Countermeasures Initiative (MCMi) Regulatory Science Program to expand efforts supporting COVID-19 medical countermeasure development. The FDA 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 further understanding of diverse responses across populations, including race, ethnicity, sex 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 new organs-on-chips to aid development and testing of countermeasures for COVID-19.
- 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 672 revisions to test EUA authorizations.
Related Information 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. |
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