GSK’s RSV vaccine ready to launch

GSK has announced that it is ready to launch its respiratory syncytial virus (RSV) vaccine in the US at some point this year. The company does not anticipate any supply constraints, and also hopes to expand into the Chinese market with the vaccine.

The company is in competition with rival, Pfizer, to launch the first approved RSV vaccine in the US. Recently a panel of external advisers to the FDA voted on both vaccines, deciding in favour of both. The FDA is expected to make an approval on the vaccines by May this year, generally following the advisory panel’s decision.

This recommendation from the advisory committee follows positive data from the company’s AReSVi-006 phase 3 trial, recently published in the New England Journal of Medicine. The trial showed GSK’s vaccine to be 82.6% effective in preventing lower respiratory tract disease in people over 60 years of age.

Phil Dormitzer, global head of vaccines R&D at GSK, commented: “Today’s vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems. Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at an increased risk of severe complications. We’re delighted that the Advisory Committee recognised the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine.”

Betsy Goodfellow