June 13, 2024,  FDA advised vaccine manufacturers that the preferred JN.1-lineage for the 2024-2025 COVID-19 vaccines) is now the KP.2 strain, if feasible. This is an update from their June 5 decision. 

The Omicron KP.2 variant is a subvariant of Omicron JN.1. The nationwide prevalence of the KP.2 variant is increasing while JN.1 is decreasing. FDA noted the change is intended to ensure that the 2024-2025 COVID-19 vaccines more closely match circulating SARS-CoV-2 strains. FDA does not anticipate a delay in U.S. vaccine availability. 

For more information, please see FDA’s website. 

June 3, 2024 - A meta-analysis of nine observational studies aimed to determine the association of early use of oral antiviral drugs with the risk of post-COVID condition (PCC) and compare the possible efficacy of nirmatrelvir-ritonavir (Paxlovid) and molnupiravir (Lagevrio). Published June 1st, in the Journal of Infection,the results showed that early use of oral antiviral drugs reduced the risk of long COVID, or post-COVID condition (PCC), by 23%, and nirmatrelvir-ritonavir may perform better than molnupiravir.  

May 13, 2024 – FDA issued a warning to home test users, caregivers, and health care providers NOT to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter (OTC) Use and its COVID-19 Test intended for patient care settings due to an increased risk of false results. The FDA issued a Warning Letter to Cue Health on May 10, 2024, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus. 

 FDA recommends healthcare providers do NOT use any Cue Health COVID-19 test and consider retesting patients using a different FDA authorized test if you suspect an inaccurate result was given from the Cue COVID-19 Test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest. Please visit the FDA webpage for more information. 

March 22, 2024 -The FDA granted an Emergency Use Authorization for the monoclonal antibody pemivibart name  Pemgarda for COVID-19 pre-exposure prophylaxis. Pemgarda is indicated for use in people aged 12 years and older, weigh at least 40 kg, who are moderately to severely immunocompromised, and do not currently have COVID-19 or have had a recent exposure to someone infected with SARS-CoV-2. 

Pemgarda is not meant to be used in place of vaccination, and people who are immunocompromised are advised to stay up to date with COVID-19 vaccines. 

For more information about Pemgarda, including an FDA black box warning, please see the resources available on the FDA’s Emergency Use Authorization webpage.