The U.S. Food and Drug Administration (FDA) issued on Feb. 24, 2023, an emergency use authorization (EUA) for the first over-the-counter, at-home diagnostic test that can detect and differentiate influenza A and B, as well as SARS-CoV-2, the virus that causes COVID-19.
The Lucira COVID-19 & Flu Home Test can be purchased without a prescription, and nasal samples can be self-collected by individuals ages 14 years or older or collected by an adult for individuals ages 2 or older.
The agency urges Americans to report their results to their health care provider for public health reporting and to receive appropriate medical care.
Pfizer Seeks to Replace Primary Series with Bivalent Vaccines
Pfizer-BioNTech announced on Feb. 24 that it seeks FDA approval for its bivalent vaccines to replace the monovalent vaccine primary series.
The bivalent vaccines protect against the original variant of SARS-CoV-2, as well as the BA.4 and BA.5 omicron subvariants.
If the company’s supplemental biologics license application is approved, individuals 12 years of age and older could receive the bivalent COVID-19 vaccine as their primary series.
The agency’s Vaccines and Related Biological Products Advisory Committee voted Jan. 26 to replace primary COVID-19 vaccine doses with the bivalent vaccine, which has been available under emergency use authorization since August 2022.
Moderna Reaches $400M Agreement with NIH
Moderna reported Feb. 23, 2023, that it paid the National Institutes of Health (NIH) $400 million in licensing fees related to the government-funded research and technology used to develop Moderna’s COVID-19 vaccine.
The agreement provides NIH low single-digit royalties on future COVID-19 vaccine sales.
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.
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