FDA reverses course and will review Moderna’s mRNA-based flu vaccine

US drug regulator originally refused to consider application, fueling critics’ concern about alleged ‘anti-vaccine agenda’

The Food and Drug Administration (FDA) reversed course on Wednesday and will now review Moderna’s application for the first mRNA-based flu vaccine after initially declining to consider it.

Moderna announced that the US drug regulator will move forward with reviewing its updated flu vaccine application. The decision comes only a week after the agency turned down the company’s original filing, a move that had prompted criticism across the medical industry about potential changes in how the regulator is making decisions under the Trump administration.

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