Pfizer: applies for license for RSV vaccine
(CercleFinance.com) - Pfizer today announced that the US FDA has agreed to grant priority review to a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate.
The FDA's priority review designation reduces the standard review period for BLAs by four months. The Prescription Drug User Fee Act (PDUFA) deadline for an FDA decision is May 2023.
Without RSV vaccines, older adults remain at risk of disease and potentially serious consequences, hospitalisation and, in some cases, death, Pfizer said.
The submission is based on the results of the RENOIR Phase 3 clinical trial.
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