Recent FDA Action & Publication Concerning COVID-19

The U.S. Food & Drug Administration (FDA) recently “authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.”  On 7/13/2022, the FDA authorized the emergency use of this vaccine for individuals 18 years of age and older.  FDA’s “rigorous analysis and evaluation of the safety and effectiveness data” led to the new authorization.  See the COVID-19 Vaccines page for information on all the COVID-19 Vaccines authorized for emergency use or FDA-approved.  The FDA also recently published the report FDA’s Work to Combat the COVID-19 Pandemic, which “outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.”  The report covers vaccines; pharmaceuticals; devices, including tests and personal protective equipment; supply chains; advanced manufacturing and innovation; inspections, investigations, imports, and fraud; and crosscutting research.