On October 7, 2024, the FDA authorized marketing for the Healgen Rapid Check COVID-19/Flu A&B Antigen, a test for COVID-19 and influenza (flu). This is the first over-the-counter (OTC) test that can detect flu to be granted marketing authorization using a traditional premarket review pathway. Other OTC flu/COVID tests are currently available under emergency use authorization.   

This test is for individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes, without a prescription. It is for individuals 14 years or older to test their own sample and can be used for individuals 2 years and older with a sample taken and tested by an adult. More information is available on FDA’s press release.  

On September 26, 2024, the FDA updated the Emergency Use Authorization (EUA) Fact Sheet for pemivibart. In vitro testing has shown that pemivibart is active against SARS-CoV-2 Omicron variants, particularly KP.3.1.1. Previously, there was concern that pemivibart might be less effective against this common variant. Table 2 of the revised EUA Fact Sheet (pages 17-21) provides information about pemivibart’s activity against individual variants.  

Pemivibart is active against the following currently circulating Omicron variants (not an exhaustive list): KP.3.1.1, KP.2, KP.3, JN.1, LB.1, and XBB. At this time, pemivibart can be used without limitation for pre-exposure prophylaxis against COVID-19 in accordance with its EUA Fact Sheet.  

Please see the CDC Nowcast for a list of currently circulating SARS-CoV-2 Omicron variants. Pemivibart's EUA Fact Sheet will continue to be revised as more data about its activity against other variants becomes available. 

On August 22, the U.S. Food and Drug Administration (FDA) approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines for people aged six months and older. These mRNA vaccines (Moderna and Pfizer) have been updated to include a monovalent (single) composition that will target the KP.2 Omicron variant to provide better protection against serious consequences of COVID-19, including hospitalization and death.  

For more details see FDA press release.  

Starting in September 2024 U.S. households will be eligible to order four free COVID-19 tests at COVIDTests.gov. The COVID-19 Tests will detect current COVID-19 variants and can be used through the end of the year. For more information on the program please visit COVIDtests.gov. 

On June 27, 2024, the Centers for Disease Control and Prevention (CDC) recommended that everyone aged six months or older get a 2024–2025 COVID-19 vaccine (Pfizer, Moderna or Novavax) this fall and winter. This followed CDC’s Advisory Committee on Immunization Practices (ACIP) discussion earlier in the day. 

Information about timing and number of doses for certain people (children, people who are moderately or severely immunocompromised) will be updated on CDC’s COVID-19 Vaccine webpage. 

The 2024–2025 COVID-19 vaccines will target the Omicron KP.2 variant, based on FDA’s June 13 recommendation. This variant is expected to be one of the most common during this upcoming respiratory season.