GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations. The GSK vaccine targets adults aged 60 and…
An overview of the RSV vaccine candidate landscape in early 2023
Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk. Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956.…
GSK wins EU nod for RSV vaccine marketing authorization application
GSK (LSE/NYSE:GSK) has won validation of the marketing authorization application from the European Medicines Agency (EMA) for its respiratory syncytial virus (RSV) vaccine candidate. GSK is pursuing authorization to use the vaccine annually in older adults. European regulators will likely announce a final regulatory decision in the third quarter of 2023. The vaccine candidate would…
Janssen begins Phase 3 study for RSV vaccine in adults 60 and older
After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine. RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually. The global EVERGREEN…