The U.S. Food and Drug Administration (FDA) rejected Moderna's application for its mRNA flu vaccine, mRNA-1010, a decision that could delay the vaccine's introduction, according to multiple news sources. The FDA cited issues with the clinical trial design, specifically with the comparator vaccine used, despite previously approving the trial's design. This rejection comes amid increased scrutiny of vaccine approvals and a challenging flu season, with less than half of adults getting a flu shot this year, according to Vox.
The FDA's decision surprised Moderna, according to Ars Technica. The rejection follows an announcement that COVID-19 vaccine mandates are no longer legally possible for healthy subjects, as reported by Fox News. The news also comes as the world is making progress toward a universal flu vaccine, according to Vox.
The rejection of Moderna's flu vaccine application is occurring against a backdrop of other significant global challenges. Multiple news sources report escalating difficulties in managing urban groundwater supplies, primarily due to climate change. These challenges impact water access, environmental agreements, and even conflict zones, as reported by Vox and Nature News.
The FDA's decision has also raised concerns, particularly given the increased scrutiny of mRNA vaccines, according to Vox. The situation is further complicated by the presence of a vocal anti-vaccine activist at the FDA, according to Ars Technica.
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