RSV Vaccine Voted 100% Effective
The race to launch a respiratory syncytial virus (RSV) vaccine for adults in the U.S. intensified today as the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of GSK Inc.' AREXVY™ (RSVPreF3 OA).
The VRBPAC voted 12-0 on effectiveness and 10-2 on safety.
This is very positive news since RSV vaccines are not currently approved anywhere in the world.
Phil Dormitzer, Global Head of Vaccines R&D, GSK said in a press release on March 1, 2023, "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 U.S. are impacted by RSV, and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications."
"We're delighted that the (FDA) Advisory Committee recognized 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."
The ACIP voted on the robust data package supporting the vaccine candidate.
This includes results from the pivotal AReSVi-006 phase III trial, recently published in the New England Journal of Medicine. Across multiple trials, the vaccine candidate was generally well tolerated with an acceptable safety profile.
In addition, GSK presented positive data on concomitant administration with seasonal quadrivalent influenza vaccination.
GSK's RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant.
This adjuvant is also contained in GSK's safe and effective Shingrix® shingles vaccine.
The role of the VRBPAC is to provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA.
In November 2022, the FDA accepted the Biologics License Application (BLA) for GSK's RSV older adult vaccine candidate under Priority Review and assigned a Prescription Drug User Fee Act action date of May 3, 2023.
GSK's RSV older adult vaccine candidate is also under regulatory review by the European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and several other regulators, with decisions expected in 2023.
RSV is a common contagious virus affecting the lungs and breathing passages, says the U.S. Centers for Disease Control and Prevention (CDC).
Most people recover in a week or two, but RSV can be serious, especially for infants and older adults.
RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than one year of age in the U.S.
The U.S. CDC Advisory Committee on Immunization Practices conducted its AREXVY review on February 23, 2023.