★ GSK announces the arrival in Spain of its vaccine specifically designed to prevent lower respiratory tract disease caused by RSV in healthy older adults and people with underlying health conditions.

GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, is now available in Spain. This vaccine is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.

RSV is a common seasonal respiratory virus that is transmitted primarily through direct contact with respiratory secretions. It is highly contagious, and there are two antigenically distinct subtypes of the virus: RSV-A and RSV-B, which coexist. Outbreaks of this virus typically occur during the coldest months, making RSV one of the viruses responsible for the so-called “tripledemic,” along with SARS-CoV-2 and influenza. RSV currently represents a major public health problem.

In Spain, the incidence of acute respiratory infections (ARIs) caused by RSV in adults over 60 years of age is estimated to be 1.62%. If we apply this figure to the Spanish population over 60 years of age in 2022, according to the National Institute of Statistics (INE), approximately 203,914 cases of RSV will occur annually in this group. Additionally, the hospitalization rate in this age group is 0.15% and the in-hospital mortality rate is 7.13%. This will result in 19,117 hospitalizations and 1,363 deaths annually due to RSV in our country. It is important to highlight that due to the limited number of diagnostic tests for RSV detection and the lack of reliable surveillance systems, global data on the burden of RSV disease among older people in Spain are insufficient, and it is likely that the available data are underestimated.

RSV infection can occur at all stages of life, although it is usually more common in newborns and older adults. In general, in most healthy adults, RSV infection usually presents with cold-like symptoms. However, due to age-related immune aging, comorbidities and immunodeficiencies may pose an increased risk of developing serious complications of RSV, such as pneumonia, exacerbation of chronic conditions (eg, COPD or heart failure), hospitalization, and death.

It’s important to note that about 80% of people over 65 have at least one underlying chronic disease, and 68% have two or more.

Iñaki Hernáez, Medical Director of Vaccines, GSK Spain, highlights “the extensive experience that GSK has in adjuvanted vaccines and in particular in the use of the AS01 adjuvant system, also present in our herpes zoster vaccine, the effectiveness of which was also observed in this RSV vaccine.” According to Hernaez, “The use of an adjuvant in the vaccine benefits older adults, especially those with underlying health conditions, as it helps enhance or modulate the immune response, allowing adequate levels of T cells to be achieved, which is necessary to reduce disease severity.”

From my side, Dr. Federico Martinon, Head of Pediatric Services, University Hospital of Santiago, Investigator of the AReSVi-006 Study (GSK’s pivotal RSV vaccine trial), highlights: “We are facing an unprecedented aging population. Mathematical models predict that by 2050, people over 60 will make up 22% of the world’s population, up 10 percentage points from 2015. These numbers make us think about the importance of vaccinations for older people and work. together to achieve the same level of vaccination in this group as in pediatric populations. In an increasingly aging society, vaccinating older people against RSV can help protect people from severe cases and reduce the burden on health care systems during periods of seasonal circulation of the virus.” Dr Martinon concluded: “It is great news to have a more accessible vaccine designed specifically for the adult population to combat a disease that has been the subject of solutions for decades.”

Efficacy of GSK RSV vaccine

In the pivotal study, the vaccine demonstrated overall efficacy of 82.6% against RSV RTD in adults aged 60 years and older during the first season and 67.2% efficacy after 2 RSV seasons (median follow-up period of 17.8 months). And for the most severe cases of RSV ETP, the effectiveness was 94.1% in the first season and 78.8% during 2 seasons.

The vaccine also demonstrated consistent efficacy against ETRI caused by various subtypes of RSV, RSV-A and RSV-B: in the first season the effectiveness was 84.6% and 80.9%, respectively, and after two seasons the effectiveness was 80.5% and 59. 7%. respectively.

39% of subjects included in both study groups had at least one concomitant cardiorespiratory or predominantly endocrine-metabolic disease. An effectiveness of 94.6% was observed over the first season and 66.7% over two seasons for participants with at least one comorbidity. In patients who had at least one concomitant cardiorespiratory disease, the effectiveness over two seasons was 73.8%.

Regarding concomitant use with other adult vaccines, it has been shown to be immunogenic and tolerable when administered concomitantly with a standard dose of quadrivalent influenza vaccine in people over 60 years of age. Safety and reactogenicity data were consistent with those initially observed in the vaccination program. Phase III clinical development, the most common adverse reactions were: pain at the injection site (61%), fatigue (34%), myalgia (29%), headache (28%) and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and disappeared within a few days of vaccination.

About Arexvi (adjuvanted RSV vaccine)

The adjuvanted RSV subunit vaccine contains as antigen a recombinant F glycoprotein stabilized in a prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary adjuvant AS01.

The vaccine was approved by the US FDA on May 3, 2023 for the prevention of RTIs caused by RSV in people aged 60 years and older. It has since also been approved in the EU, UK, Canada, Japan, Brazil, Hong Kong and the Philippines. Inspections are carried out by regulatory authorities in other countries. The proposed trade name remains subject to regulatory approval in other markets. The vaccine has been accepted for regulatory review by the European Medicines Agency (EMA) for the prevention of RSV in high-risk adults aged 50 to 59 years. The current EMA-approved indication is for adults 60 years and older.

GSK’s proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant, licensed from Antigenics Inc., a subsidiary of Agenus Inc.

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