FDA Reverses Decision on Moderna's Flu Vaccine Amid Public Pressure

Moderna's flu vaccine faced a turbulent week as the U.S. Food and Drug Administration (FDA) initially rejected its application, only to reverse the decision a week later. The scrutiny raised concerns over changing regulatory policies under the Trump administration, affecting investor confidence and Moderna's stock prices.

The FDA's refusal was made public by Moderna, leading to discussions on the vaccine's design and its safety implications for older adults. A revised application was accepted by the FDA following a meeting, aiming for full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and above. This requires a post-marketing confirmatory study.

The episode underscores tensions between public perception, corporate interests, and regulatory frameworks, especially regarding mRNA technology. Analysts observed that leveraging public pressure might aid Moderna in navigating future challenges with regulatory authorities.