On June 2024, the U.S. Food and Drug Administration (FDA) approved Novavax’s COVID-19 vaccine for use in the United States, but with specific restrictions. Novavax’s vaccine is unique among COVID-19 vaccines available in the U.S. because it is protein-based, as opposed to the mRNA-based vaccines developed by Pfizer-BioNTech and Moderna. Previously, the Novavax vaccine was authorized only for emergency use, which allowed its distribution under specific circumstances during the public health emergency. The new FDA approval changes its status to full approval, but the agency has imposed certain limitations on its use. The details of these restrictions have not been fully disclosed in the initial announcement. The approval provides an alternative for individuals who may not be able or willing to receive mRNA vaccines. The FDA’s decision is based on a review of clinical trial data and ongoing monitoring of vaccine safety and efficacy. Novavax’s vaccine uses a more traditional protein subunit technology, which may appeal to those hesitant about newer vaccine platforms. The approval process reflects the FDA’s ongoing efforts to provide multiple vaccine options for COVID-19 prevention in the United States.