The U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2. However, the national emergency is over, and despite a SARS-CoV-2 surge this summer, morbidity and mortality rates dramatically decline with each evolving strain. For example, TrialSite has exposed how the Centers for Disease Control and Prevention (CDC) continues to misrepresent actual deaths due to COVID-19. The actual number of deaths has dramatically dropped over the past two years. Factoring and balancing all of the inputs—including the fact that the EUA mechanism allows for more flexible evidentiary standards—are the FDA’s EUAs for Novavax and other mRNA EUA for young children appropriate? According to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, “The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention.” Marks was cited in an agency press release in regard to the Novavax EUA, “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”