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Results For "RSV-vaccine"

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USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Moderna announces an investigational respiratory syncytial vaccine mRNA-1345
News | January 23, 2023

Moderna announces an investigational respiratory syncytial vaccine mRNA-1345

mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


MVA-BN respiratory syncytial virus vaccine could get first-to-market opportunity in China, says GlobalData
Biotech | May 29, 2022

MVA-BN respiratory syncytial virus vaccine could get first-to-market opportunity in China, says GlobalData

RSV is the most common viral cause of respiratory tract infections in newborns, young children, older adults, or the immunocompromised