Veronica Hulstrøm MD, PhD Senior Director Clinical Project Lead for RSV Older Adults GSK

NEJM: GSK Vaccine Found Highly Effective Against RSV Respiratory Disease in Older Adults Interview with:

Veronica Hulstrøm MD, PhDSenior Director Clinical Project Lead for RSV Older Adults GSK

Dr. Hulstrøm

Veronica Hulstrøm MD, PhD
Senior Director
Clinical Project Lead for RSV Older Adults
GSK What is the background for this study?

Response: The AReSVi-006 phase III trial is designed to investigate the efficacy and safety of GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above. The phase III trial is a randomized, placebo-controlled, double-blind, international trial with 24,966 participants who received either the investigational vaccine or placebo. What are the main findings?

Response:  Results showed the vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% against RSV-related lower respiratory tract disease (RSV-LRTD). Notably, high vaccine efficacy was also observed against severe RSV disease and for people with underlying health conditions like chronic respiratory or heart disease – the patients who suffer the most. The study observed vaccine efficacy of 94.1% against severe RSV-LRTD and 94.6% in adults with underlying health conditions of interest.

The vaccine was well tolerated with a favorable safety profile, with observed adverse events typically being mild-to-moderate and transient. The most frequent solicited adverse events were injection site pain, fatigue, myalgia, and headache. What should readers take away from your report?

Response: RSV is a highly contagious seasonal virus that co-circulates with other respiratory viruses, like flu and COVID-19. It causes over 470,000 hospitalizations and 33,000 deaths in adults aged 60 years and above in high-income countries every year. Those at the greatest risk for severe outcomes of RSV are people living with underlying health conditions like chronic respiratory disease or heart disease.

As there is currently no vaccine or specific treatment available for RSV in adults, these encouraging findings offer hope that a vaccine may be on the horizon to help reduce the significant global burden of RSV. What recommendations do you have for future research as a results of this study?

Response: GSK is conducting three additional phase III clinical trials that aim to expand the population who may benefit from RSV vaccination into adults aged 50-59 with underlying co-morbidities and to provide further evidence on co-administration with other older adult vaccines.

These are fully recruited, and results are expected in 2023, together with additional data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III efficacy trial and the AReSVi-004 immunogenicity trial. These clinical trials continue to evaluate an annual revaccination schedule and efficacy/immunogenicity over multiple seasons following one or three doses of the RSV vaccine candidate. Is there anything else you would like to add? Any disclosures?

Response: This is the first peer-reviewed publication of phase III respiratory syncytial virus vaccine data in older adults, including those with underlying health conditions who are most at risk. GSK is on track to deliver potentially the first RSV vaccine for older adults in 2023, pending regulatory approvals, with a decision from the FDA expected by May 3, 2023.


Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults A. Papi, M.G. Ison, J.M. Langley, D.-G. Lee, I. Leroux-Roels, F. Martinon-Torres, T.F. Schwarz, R.N. van Zyl-Smit, L. Campora, N. Dezutter, N. de Schrevel, L. Fissette, M.-P. David, M. Van der Wielen, L. Kostanyan, and V. Hulstrøm, for the AReSVi-006 Study Group*
N Engl J Med 2023;388:595-608. DOI: 10.1056/NEJMoa2209604 Feb 16 2023

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Last Updated on March 14, 2023 by Marie Benz