The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of RSVPreF3, a respiratory syncytial virus (RSV) vaccine candidate, to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in adults 60 years of age and older.
The FDA panel reviewed data from 5 clinical studies, including the phase 3 AReSVi 006 trial (ClinicalTrials.gov Identifier: NCT04886596), which compared the efficacy and safety of RSVPreF3 to placebo in approximately 25,000 adults 60 years of age and older. The primary endpoint of the study was the number of participants with first episode of reverse transcriptase-polymerase chain reaction confirmed RSV A and/or B associated with LRTD during the first seasons following a single dose of RSVPreF3.
Vaccine efficacy was reported to be 82.6% (96.95% CI, 57.9-94.1), with 7 cases in the vaccine arm compared with 40 cases in the placebo arm. The median follow-up time was 6.7 months for both study groups. The magnitude of effect was observed to be consistent across RSV A and B strains and in patients 70 years of age and older. The vaccine was well tolerated with no safety concerns reported. The most commonly observed solicited adverse events were injection site pain, fatigue, myalgia, and headache.
Based on the data package, the panel voted unanimously (12 to 0) on effectiveness and 10-2 on safety. The Biologics License Application is under Priority Review and has a Prescription Drug User Fee Act target date of May 3, 2023.
Phil Dormitzer, Global Head of Vaccines R&D, GSK said: “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 health care systems. […] We’re delighted that the 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.”
- US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate. News release. GSK. March 1, 2023. Accessed March 2, 2023. https://us.gsk.com/en-us/media/press-releases/us-fda-advisory-committee-votes-to-support-effectiveness-and-safety-of-gsk-s-rsv-older-adult-vaccine-candidate/.
- GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA. News release. GSK. November 2, 2022. Accessed March 2, 2023. https://us.gsk.com/en-us/media/press-releases/gsk-s-rsv-oa-vaccine-candidate-granted-priority-review-by-us-fda/.
- Vaccines and Related Biological Products Advisory Committee Meeting. FDA Briefing Document: Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted (Proposed Trade Name: Arexvy). Accessed March 2, 2023. https://www.fda.gov/media/165622/download.