FDA Approves Expanded Label for GSK RSV Vaccine


The federal agency’s decision expands the vaccine’s eligibility to people 50 years of age and older, making it the first one for this age group.

FDA logo; Image credit: FDA

Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.

Image credit: FDA

In a move that will make younger adults eligible for RSV vaccines, the FDA approved an expanded label for the GSK RSV vaccine, Arexvy (RSVPreF3 +AS01E), to include adults 50-59 years of age. Previously, the vaccine was approved to prevent RSV lower respiratory tract disease (RSV-LRTD) in adults 60 years and older. 1

“I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider," Ann R. Falsey, MD, professor University of Rochester School of Medicine, said. "Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them.”1

When the application for a younger subpopulation for the GSK RSV vaccine was accepted in February, the company said this expanded label is for adults aged 50-59 who are at increased risk for RSV disease.2

Trial Specifics, Results
According to GSK, their trial, NCT05590403, is an ongoing phase 3, placebo-controlled, observer-blind, randomized, multi-country immunogenicity trial to evaluate the non-inferiority of the immune response and evaluate safety in participants aged 50 to 59 at increased risk of RSV-LRTD compared to older adults aged 60 years and above after a single dose of GSK’s RSV vaccine.2

Last fall, GSK announced preliminary results from this trial showing primary endpoints met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older.2

Immune response in participants aged 50 to 59 with pre-defined stable chronic diseases leading to an increased risk of RSV disease was assessed (n=570). These included participants with chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney disease or chronic liver disease. Immune responses in a broader group of participants aged 50 to 59 without these pre-defined chronic diseases (n=570) was also evaluated compared to adults aged 60 and older. Approximately 1520 participants were enrolled across 8 countries.2

The trial’s primary endpoints were RSV-A and RSV-B neutralization titers of both groups of 50 to 59 year old participants at 1 month after the vaccine administration compared to adults aged 60 and older. There were also safety and immunogenicity secondary and tertiary endpoints. 2

The Initial FDA Approval

Last year, GSK’s Arexvy became the very first FDA approved RSV vaccine. The FDA approval came after reviewing positive phase 3 data from GSK’s AReSVi-006 (Adult Respiratory Syncytial Virus) trial. “Our primary endpoint in our study was to look at protection against lower respiratory tract disease caused by RSV, which gives us an excellent efficacy of about 82.6%,” Temi Folaranmi, MD, vice president, US Medical and Clinical Affairs, Vaccines at GSK, said at the time of the approval. “We also look at other endpoints such as acute respiratory illness, which gives us a very high efficacy as well.”3

Further Submissions
GSK has also filed regulatory submissions to extend the use of its RSV vaccine to adults aged 50-59 at increased risk in Europe, Japan and other geographies with regulatory decisions undergoing review. Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in H2 2024.


1. US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. GSK press release. June 7, 2024. Accessed June 7, 2024.
2.New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. GSK media statement. October 25, 2023. Accessed June 7, 2024.
3. Cosdon N.FDA Approves GSK’s Arexvy as the World’s First RSV Vaccine for Older Adults.Contagion. May 3, 2023. Accessed June 7, 2024.

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