STAT+: Pharmalittle: We’re reading about an FDA reversal on a Moderna vaccine, the U.K. life sciences sector, and more

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Source: STAT News

Original: https://www.statnews.com/pharmalot/2026/02/18/fda-moderna-vaccines-hhs-kennedy/?...

Published: Wed, 18 Feb 2026 14:41:09 +0000

The FDA changed its stance and told Moderna that it would reconsider its application for approval of a new mRNA-based flu vaccine, which it had declined to review in early February 2026[1]. Initially, the FDA rejected Moderna's application on the grounds that the manufacturer "refused to follow FDA's clear 2024 guidance and test its product in a clinical trial with a CDC-recommended flu vaccine to compare safety and efficacy"[1]. Moderna subsequently requested a meeting with the FDA after receiving a letter denying its application[1]. This situation concerns mRNA technology, which was key to the rapid development of vaccines against COVID-19 during the pandemic[1]. The FDA's decision to reevaluate the application represents a change in the US regulatory agency's stance toward this Moderna project.