Published Data Show Why GSK Bailed on Its Maternal RSV Vaccine
GSK’s abandoned maternal respiratory syncytial virus (RSV) vaccine protected infants from severe RSV, final results of a phase III trial indicated, but those positive outcomes came at the expense of an unexplained higher risk for preterm birth. For newborns up to 6 months of age, efficacy with the RSV prefusion F protein-based vaccine (RSVPreF3-Mat) during […]
RSV Vaccine Maintains Efficacy Across Two Seasons in Seniors
BOSTON — Efficacy of GSK’s respiratory syncytial virus (RSV) vaccine held strong through two RSV seasons in adults 60 and over, according to new results from the company’s pivotal trial. With a single dose, efficacy of the RSV perfusion F protein vaccine (Arexvy) against RSV-related lower respiratory tract disease declined from 82.6% during the first […]
Second RSV Vaccine for Older Adults Gets Thumbs Up From FDA Advisors
A panel of FDA’s outside advisors recommended the agency approve GSK’s respiratory syncytial virus (RSV) vaccine for older adults, a day after backing Pfizer’s RSV vaccine candidate for that same population. By votes of 12-0 on efficacy and 10-2 on safety, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the available data support […]