GSK's RSV vaccine gains support from US FDA AdCom for older adults
The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of UK pharma major GSK’s (LSE: GSK) respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.
The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety. However, the AdCom experts expressed concern that the vaccine could be associated with risks of rare nervous system disorders such as Guillain-Barre syndrome.
Just a day earlier, the same AdCom reached a similar conclusion in a narrow 7 to 4 vote relating to rival Pfizer’s (NYSE: PFE) application to clear its RSV vaccine in older patients.
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