Pregnancy Drug Safety Lacking; Flu Shot Rejected

FDA Rejects Moderna's mRNA Flu Vaccine Application, Citing Trial Design Flaws

The U.S. Food and Drug Administration (FDA) rejected Moderna's application for its mRNA-based flu vaccine, citing issues with the clinical trial design, according to multiple news sources. The decision, which surprised Moderna, comes amid increased scrutiny of vaccine approvals and ongoing debates surrounding mRNA technology.

The FDA's rejection of the application was based on flaws in the trial design and the comparator vaccine used, according to Ars Technica. The decision has raised concerns, particularly given the increased scrutiny of vaccine approvals and a shift in COVID-19 vaccine mandates, as reported by Vox. Moderna announced the FDA's decision, which highlights the challenges in vaccine development and approval processes.

This rejection comes at a time when vaccine research and recommendations are under increased scrutiny, with some policies negatively impacting research, according to Ars Technica. The news also comes as pregnant people and their healthcare providers often rely on limited data to weigh the risks of taking medications, as reported by Nature News. For example, in 2021, when Kristin Wall became pregnant, her physician told her that little was known about the COVID-19 vaccines safety and effectiveness in pregnant people.

The rejection of Moderna's flu vaccine application is one of several developments impacting public health. Simultaneously, challenges in managing urban groundwater supplies are escalating due to climate change, impacting water access, environmental agreements, and conflict zones, according to Vox.