Coronavirus (COVID-19) Update: August 6, 2021

FDA News Release

• For Immediate Release: August 06, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, FDA announced that it has found certain 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 FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now 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.
• On August 3, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to Blue Willow Biologics for selling an unapproved product with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider.
• On August 4, the FDA approved an abbreviated new drug application for dexamethasone sodium phosphate injection. Dexamethasone injection is used to treat conditions such as arthritis, blood disorders, hormone disorders, allergic reactions, skin diseases, eye disorders, breathing problems, bowel disorders, cancer, and immune system disorders. Side effects include fluid retention, sodium retention, impaired wound healing, and muscle weakness. This drug is included in the FDA Drug Shortage Database and in the Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency. FDA recognizes the increased demand for certain products during the COVID-19 public health emergency and has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID-19. We remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American public.
• Testing updates:
  • As of today, 399 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 279 molecular tests and sample collection devices, 87 antibody and other immune response tests and 33 antigen tests. There are 53 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, three antigen prescription at-home tests, six antigen over-the-counter (OTC) at-home tests and two molecular OTC at-home tests.
  • The FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 596 revisions to EUA authorizations.