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May 17, 2024

FDA Extends Review of Moderna’s RSV Vaccine

Moderna is currently seeking FDA approval for its new respiratory syncytial virus (“RSV”) vaccination, which would be only the third RSV vaccine to receive FDA approval.  Pursuant to a recent news release, however, Moderna was informed by the FDA that the agency would not be able complete its review of the company’s RSV vaccine by the previously communicated May 12, 2024 date.  Apparently citing “administrative constraints,” the FDA indicated that it anticipated completing its review “by end of May.”  Moderna’s press release stated that the agency “has not informed Moderna of any issues related to vaccine safety, efficacy or quality.” 

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