FDA Update: Agency Closely Monitoring Emergence of XBB.1.5 Subvariant

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

The FDA posted this news release on Friday, January 6, 2023.

  • Today, the FDA posted an update that the agency is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), the FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.
  • Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld. 
  • If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate. 

COVID-19 testing updates: 

  • As of today, 442 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 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, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
  • The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1197 revisions to EUA authorizations.

For additional information about the XBB.1.5 variant, reference this from Johns Hopkins University, Bloomberg School of Public Health: What You Need to Know About XBB.1.5, the Latest Omicron Variant.