The positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is based on Phase III study data showing statistically significant and clinically meaningful efficacy of the new RSV vaccine candidate in adults aged 60 years and older. To date, no vaccination against RSV is available in Europe.
(red) Respiratory syncytial virus (RSV) is a worldwide contagious virus that affects the lungs and respiratory tract. It is one of the most important infectious diseases for which there is currently neither a vaccine nor a specific treatment in Europe [1,2]. RSV infection is possible at any age. Pharmaceutical company GlaxoSmithKline’s (GSK) new vaccine candidate Arexvy received a positive opinion from the CHMP for the indication of prevention of RSV-induced lower respiratory tract disease ( LRTD) in people over 60 years of age. This decision was based on data demonstrating a high level of vaccine protection in this subpopulation, particularly among those with pre-existing underlying diseases [1,2]. The application for marketing authorization of Arexy will be reviewed in an accelerated procedure. The final decision of the EMA (European Medicines Agency) on a marketing authorization for Arexvy is expected towards the end of July this year. To date, no vaccination is available that protects this group of individuals from the potential consequences of RSV infection. [1,2].
Age group over 60 years: Risk group for severe course
In humans, the virus is transmitted by droplet infection during close contact, with the conjunctiva and nasal mucosa being the ports of entry. Transmission is also possible through contaminated objects and surfaces (including hands). Contagiousness usually persists for 1 to 5 days. It reaches its peak during the first days of the disease. Older adults are at high risk for severe disease due to age-related decline in immunity and comorbidities. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, and can lead to serious consequences such as pneumonia, hospitalization, and death. Each year, RSV causes over 360,000 hospitalizations and 24,000 deaths in adults worldwide [1,3]. Adults with underlying conditions are more likely to need to see a physician and have more frequent hospitalizations than adults without these conditions [1].
| GlaxoSmithKline’s (GSK) RSV vaccine candidate for older adults aged 60 years and older contains a recombinant RSV F glycoprotein antigen (RSVPreF3) in combination with GSK-developed adjuvant AS01. AS01 is used in several of GSK’s established adjuvanted vaccines. The technological combination of antigen and adjuvant may help overcome the natural age-related decline in immunity, helping to protect older adults from RSV disease. |
| to [1,2] |
Vaccine candidate convinced in studies
The positive opinion is based on data from the pivotal Phase III AReSVi-006 (Adult Respiratory Syncytial Virus) trial. In the study, 24,966 participants received either a dose of the vaccine (n=12,467) or placebo (n=12,499). Overall efficacy against RSV-LRTD was 82.6% (96.95% CI; 57.9-94.1) in adults 60 years and older [2,4]. 7 of 12,466 of the vaccinated subjects vs. 40 of 12,494 of the placebo group developed RSV-LRTD [2,4]. Thus, the primary endpoint was met. In older adults with at least one relevant underlying condition, such as certain cardiorespiratory and endocrine-metabolic diseases, efficacy was 94.6% (95% CI; 65.9-99.9), or 1 of 4937 vs. 18 of 4861 RSV-LRTD cases [2].
| The Phase III AReSVi 006 study is a randomized trial, placebo-controlled, observer-blinded study in multiple countries to demonstrate efficacy of a single dose of GlaxoSmithKline’s adjuvanted RSVPreF3 OA vaccine candidate in adults 60 years of age and older. About 25,000 participants from 17 countries were included in the study. |
| to [1,2] |
In several studies, the vaccine candidate was generally well tolerated and had an acceptable safety profile. The most commonly observed adverse events were injection site pain, fatigue, myalgia, and headache. These were usually mild to moderate in severity and transient [2].
Source: GlaxoSmithKline
Literature:
- “GSK releases positive Phase III registration data for its respiratory syncytial virus (RSV) vaccine candidate for older adults,” GSK, June 10, 2022.
- “GSK’s respiratory syncytial virus older adult vaccine candidate gains positive European Medicines Agency CHMP opinion,” GSK, April 27, 2023.
- Shi T, et al: Global Disease Burden Estimates of Respiratory Syncytial Virus-Associated Acute Respiratory Infection in Older Adults in 2015: A Systematic Review and Meta-Analysis. Journal of Infectious Diseases, 2020; 222: S577-S583.
- Papi A, et al: AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. NEJM 2023; 388(7): 595-608.
HAUSARZT PRAXIS 2023; 18(6): 27
