In June 2023, the European Commission authorized a vaccine for active immunization to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 and over. This marks a significant public health milestone, as RSV is a frequent cause of severe respiratory illness in older adults.
RSV is a common respiratory virus that typically causes mild cold-like symptoms but can lead to serious illness in vulnerable individuals, such as the elderly or those with chronic lung or heart disease, and diabetes. Each year in Europe, RSV is responsible for approximately 250,000 hospitalizations and 17,000 in-hospital deaths among people aged over 65.
In response to the global burden of RSV, new prevention strategies are being developed, including monoclonal antibodies and vaccines.
Currently, a humanized monoclonal anti-RSV antibody is available as a specific prophylactic option. It is indicated for the prevention of severe lower respiratory tract manifestations in infants at high risk of RSV-related illness, such as premature newborns and infants with chronic lung disease or congenital heart defects. This treatment is administered via monthly intramuscular injections during the virus’s peak season. It has been shown to reduce hospitalizations by about 50%.
In 2023, AIFA (Italian Medicines Agency) authorized the use of a monoclonal antibody for the prevention of RSV-caused lower respiratory tract infections (LRTI) in infants and young children during their first year of life. The antibody has demonstrated an 80% effectiveness in reducing RSV infections requiring medical attention and a 77% reduction in hospitalizations. It is administered as a single intramuscular injection and offers protection lasting at least five months during the autumn/winter season, when RSV circulation is at its highest.
The New Adjuvanted Recombinant Vaccine
In October 2023, AIFA approved the first RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus in adults aged 60 and over.
This vaccine contains the RSVPreF3 antigen (recombinant, adjuvanted) and is administered as a single intramuscular injection in the deltoid muscle. Its safety was assessed through a Phase III trial conducted in Europe, North America, Asia, and the Southern Hemisphere. Vaccination may cause mild and temporary side effects such as injection site pain, fatigue, muscle aches, headache, and joint pain.
Vaccine for Pregnant Women and Adults Over 60
Also in 2023, another RSV vaccine was approved for pregnant women between the 24th and 36th week of gestation, allowing them to be vaccinated to provide effective protection for their newborns up to six months of age.
This is a non-adjuvanted bivalent RSV vaccine composed of two preF proteins (RSVpreF), administered as a single-dose intramuscular injection. Among adults aged 60 and older, as well as pregnant women, the most common adverse reactions reported were injection site pain, headache, muscle aches, and nausea.
Following the recommendation of the European Medicines Agency (EMA), the European Commission granted marketing authorization at the EU level. The vaccine is expected to become available in Italy soon.
Bibliography
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- https://www.repubblica.it/salute/2023/06/06/news/virus_respiratorio_sinciziale_rsv_vaccini-403418728/
- Protect against RSV with Pfizer’s vaccine ABRYSVO https://www.abrysvo.com
- Respiratory Syncytial Virus Infection, 2022, H. Jain, J. W. Schweitzer, N. A. Justice, National Library of Medicine. Disponibile all’indirizzo:
- https://www.ncbi.nlm.nih.gov/books/NBK459215/
- Virus respiratorio sinciziale, l’Fda approva il primo vaccino per le donne in gravidanza per prevenire l’RSV nei neonati – ParmaStar
- Virus sinciziale, Genova uno dei 4 centri italiani dove vaccinarsi – Primocanale
- https://www.youtube.com/watch?v=UL7KV6kKwtE
