FDA Approves Expanded Age Indication for RSV Vaccine Arexvy

The FDA has granted an expanded age indication for GSK’s Arexvy for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in patients aged 50 to 59 years who are at an increased risk.¹

“Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50 to 59 who are at increased risk,” said Tony Wood, chief scientific officer, GSK, in the company’s press release.¹“For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”

In May 2023, the FDA’s approval of Arexvy made it the first vaccine approved for use in patients aged 60 years and older in the United States to prevent LRTD associated with RSV.²

RSV is a common contagious virus, in which adults can be at an increased risk due to comorbidities, immune compromised status, or advanced age.¹ Additionally, RSV is estimated to cause approximately 177,000 hospitalizations in adults aged 65 years and older, and 42,000 hospitalizations in adults aged 50 to 64 years in the United States, each year.

The vaccine was also approved for the prevention of RSV-LRTD in individuals aged 60 years and older in over 40 countries, including Europe and Japan.

Data Supports Efficacy and Safety

The approval was supported by positive results from a phase 3 trial (NCT05590403) on the immune response efficacy and safety of the vaccine in those aged 50 to 59 years, including those at increased risk for RSV-LRTD due to underlying medical conditions.

Approved RSV Vaccines

Arexvy from GSK was the first vaccine approved by the FDA in May 2023 in adults age 60 years and older.
Abrysvo from Pfizer is approved with 2 indications: in adults age 60 years and older and in pregnant individuals between 32- and 36-weeks’ gestational age to prevent LRTD and severe LRTD in infants through 6 months of age.
mResvia from Moderna was the most recent approval and is a single-dose vaccine for adults age 60 years and older.

The study evaluated the immune response in 570 patients with pre-defined stable chronic diseases that put them at increased risk for RSV disease. Immune responses in 570 patients without these pre-defined chronic diseases were also evaluated compared with patients aged 60 years and older. The study’s primary end points were RSV-A and RSV-B neutralization titres of both groups at 1-month after vaccine administration compared with adults aged 60 years and older.

Results from this trial were presented at the Advisory Committee on Immunization Practices meeting in October 2023, and at ReSVinet in February 2024.

Safety and reactogenicity data were consistent with initial results, and the most common local adverse event was pain (60.9%). The most common systematic adverse events were myalgia (28.9%), fatigue (33.6%), and headache (27.2%), largely ranging from mild to moderate in intensity.³

Additionally, GSK has filed regulatory submissions to extend the use of the vaccine to adults aged 50 to 59 years at increased risk in Europe, Japan, and other regions where regulatory decisions are undergoing review.¹Furthermore, trials evaluating the immunogenicity and safety of the vaccine in adults aged 18 to 49 years who are at increased risk, as well as immunocompromised adults aged 18 years and older are expected to be presented in 2024.

“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 in the press release.¹ “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.”

3. Arexvy. Package insert. GSK; 2024. Accessed June 11, 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF