The Food and Drug Administration (FDA) on Aug. 22 approved and granted emergency use authorization for updated Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines to include a monovalent component that targets the KP.2 strain of the omicron variant of SARS-CoV-2, the virus that causes COVID-19.
Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax are approved for individuals ages 12 and older, and the Pfizer-BioNTech and Moderna COVID-19 vaccines are authorized for emergency use in those 6 months through 11 years of age.
Notably, the approved lineage differs from FDA’s initial recommendation in June that the 2024–2025 COVID-19 vaccines target the JN.1 variant, due to the virus’ evolution and a rise in cases. According to wastewater surveillance data from the Centers for Disease Control and Prevention (CDC), the United States is experiencing the largest surge of summer cases in two years. Currently, KP.3.1.1 is the predominant SARS-CoV-2 variant circulating.
HHS to Offer Additional No-Cost Tests
The Department of Health and Human Services announced that it will again offer four COVID-19 tests at no cost to every household in the nation starting at the end of September. The tests will detect current COVID-19 variants and can be used through the end of 2024.
The announcement comes as the CDC’s Bridge Access Program is scheduled to end at the end of August. Since September 2023, the program has provided no-cost COVID-19 vaccines to adults who do not have health insurance or whose insurance does not cover all COVID-19 vaccine costs.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.