FDA approves Novavax COVID-19 vaccine with restrictions

The FDA approved Novavax’s (NVAX) COVID-19 vaccine in a letter to the company dated Friday. “Under this license, you are authorized to manufacture the product COVID-19 Vaccine, Adjuvanted, which is indicated for active immunization to prevent coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 in adults 65 years and older. Additionally, COVID-19 Vaccine, Adjuvanted is indicated for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.” The agency added, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”