GSK Respiratory Syncytial Virus (RSV) Vaccine Arexvy Now Available in Spain: Prevention of Lower Respiratory Tract Infections in Adults 60 and Older

GSK respiratory syncytial virus (RSV) vaccine, Arexvynow available in Spain. This vaccine is indicated for the prevention of lower respiratory tract infections. (ETRI) caused by RSV in adults aged 60 and older. RSV is a common, seasonal respiratory virus that is transmitted primarily through direct contact with respiratory secretions. It is very contagious and there are two different subtypes of the virus, RSV-A and RSV-B, which are related. Outbreaks of this virus usually occur in the colder months, making RSV one of the viruses responsible for the so-called “tripledemia”, along with SARS-CoV-2 and influenza big Currently, RSV represents a major public health problem.

In Spain, the prevalence of Acute Respiratory Infections (ARIs) due to RSV in adults over 60 years is estimated at 1.62 percent. Applying this rate to the population over 60 years of age in Spain in 2022 according to the National Institute of Statistics (INE), there would be approximately 203,914 cases of RSV per year in this group. In addition, The hospitalization rate in this age group is 0.15 percent, with an in-hospital mortality rate of 7.13 percent. This would translate to 19,117 hospitalizations and 1,363 deaths per year due to RSV in our country. It is important to highlight that, due to the small number of diagnostic tests to detect RSV and the lack of robust monitoring systems, global data on the burden of RSV disease in older adults in Spain are not sufficient and the data are likely which is available. understood.

RSV infection can occur at any stage of life, although it is usually more relevant in newborns and older adults. In general, in most healthy adults, RSV infections usually present with cold-like symptoms. However, due to age-related immunity, underlying medical comorbidities and immunosuppressive conditions may increase the risk of developing severe RSV complications such as pneumonia, exacerbation of chronic pathologies (eg, COPD or heart failure ), hospitalization, and death.

It is important to remember that around 80 percent of people over 65 have at least one chronic disease and 68 percent have two or more.

“GSK’s extensive experience in improved vaccines and particularly in the use of the AS01 adjuvant system, also present in our vaccine against herpes zoster, whose effectiveness was also seen in this vaccine against RSV,” clarifies Iñaki Hernáez, medical director of GSK’s vaccines region in Spain. According to Hernáez, “The use of the adjuvant in the vaccine is an advantage for older adults, especially those with comorbidities, because it helps to increase or modify the immune response, allowing adequate levels of T lymphocytes to be achieved, which is necessary to reduce the level of T lymphocytes. how bad the disease is.”

For his part, Federico Martinón, head of the Pediatric Service at the Clinical Hospital of the University of Santiago, researcher on the study AReSVi-006 (an important trial of the GSK vaccine against RSV), reveals that “We are facing an unprecedented aging population. The project’s mathematical models project that people over 60 will represent 22 percent of the world’s population by 2050, an increase of 10 percentage points from 2015.. These numbers invite us to reflect on the importance of childhood vaccination and to work together to achieve similar vaccination rates in this group to those obtained in older ages. pediatric. In an increasingly aging society, vaccination against RSV in older adults could help protect people from serious cases and reduce the burden on health care systems during periods of virus circulation seasonal.” Martinón concludes by saying “It is good news to have a vaccine available, designed specifically for the adult population, to deal with a disease that has been the subject of research for solutions for decades. “

Vaccine effectiveness

In the pivotal study, the vaccine showed an overall efficacy of 82.6 percent against ETRI with RSV in adults aged 60 years and older in the first season, and an efficacy of 67.2 percent after 2 seasons of RSV (median follow-up of 17.8 months). And for the most severe cases of RSV ETRI, efficacy was 94.1 percent in the first season and 78.8 percent over two seasons.

The vaccine has also shown consistent efficacy against ETRI caused by different subtypes of VRS, VRS-A and VRS-B: In the first season the efficiency was 84.6 percent and 80.9 percent respectively and after two seasons the efficiency was 80.5 percent and 59.7 percent respectively.

39 percent of the subjects included in each group of the study had at least one cardiorespiratory or endocrine-metabolic comorbidity, mostly. An efficacy of 94.6 percent was seen in the first season and 66.7 percent over two seasons for participants with at least one comorbidity.. In those patients who had at least one cardiorespiratory comorbidity, efficacy over two seasons was 73.8 percent.

Regarding co-administration with other adult vaccines, has been shown to be immunogenic and tolerable when co-administered with standard-dose quadrivalent influenza vaccine in people over 60. Safety and reactogenicity data were consistent with those initially observed in the Phase III clinical development program with the most frequently reported adverse effects being injection site pain (61 percent), fatigue (34 percent), myalgia (29 percent), headache (28 percent). and arthralgia (18 percent). These side effects were usually mild or moderate in intensity and disappeared a few days after the vaccination.

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