Moderna announces that the U.S. Food and Drug Administration (FDA) has informed it that, due to 'administrative constraints', it will not be able to complete its review of the Biologics License Application (BLA) for mRNA-1345, its investigational vaccine against respiratory syncytial virus (RSV), by May 12, the investigational vaccine against respiratory syncytial virus (RSV).

The FDA informed Moderna that it would endeavor to conclude the review by the end of May.

Moderna states that the FDA has not raised any issues related to vaccine safety, efficacy or quality that would prevent approval of mRNA-1345.

Moderna hopes that mRNA-1345 will be reviewed at the CDC's Advisory Committee on Immunization Practices (ACIP) meeting on June 26-27, 2024, a necessary step before commercial launch.

We look forward to helping the agency complete its review of our application, and to participating in the June ACIP meeting," said Stephen Hoge, M.D., President of Moderna.




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