The U.S. Food and Drug Administration’s (FDA)’s Vaccines and Related Biological Products Advisory Committee voted unanimously on Jan. 26 to replace primary COVID-19 vaccine doses with bivalent vaccines that protect not only against the original variant of SARS-CoV-2, the virus that causes COVID-19, but against BA.4 and BA.5 omicron subvariants as well.
Currently, the bivalent vaccines offered by Pfizer and Moderna are available only to those who have received two doses of the original monovalent COVID-19 vaccine.
A study published Jan. 25, 2023, in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report found that bivalent COVID-19 booster vaccines also protect adults against XBB and XBB.1.5, the newest circulating omicron subvariants. COVID-19 cases caused by the XBB and XBB.1.5 subvariants currently account for 64 percent of COVID-19 cases in the nation.
The advisory committee now awaits the FDA commissioner’s approval of their decision.
FDA Rescinds Evusheld Emergency Use Authorization
The FDA announced on Jan. 26, 2023, that Evusheld, AstraZeneca’s monoclonal antibody medication to treat COVID-19, no longer is authorized for emergency use in the United States.
The decision stems from CDC data indicating the treatment is unlikely to protect against more than 90 percent of SARS-CoV-2 variants currently circulating throughout the nation.
The agency notes that certain antiviral therapeutics for COVID-19 treatment remain effective, including ritonavir-boosted nirmatrelvir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio).
CDC Launches COVID-19 Testing Locator
The CDC launched on Jan. 24, 2023, the COVID-19 Testing Locator, making it easier for Americans to search for no-cost COVID-19 testing sites near them.
The locator, part of the CDC Increasing Community Access to Testing (ICATT) program, is geared toward those at a greater risk of being affected by the pandemic, including those without health insurance.
The tests are billed to third-party payers, such as Medicare, Medicaid, and private health insurers, and those with no insurance do not have to pay for testing at ICATT locations.
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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