A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year. The RSV vaccines Arexvy (GSK), Abrysvo (Pfizer), and Mresvia (Moderna) are approved for medical use in the United States. Arexvy is approved for medical use in the United States, in the European Union, and in Canada for people aged 60 years of age and older. Arexvy is approved in the US for people aged 50–59 years of age who are at increased risk. In June 2024, the US Centers for Disease Control and Prevention (CDC) updated its recommendation for the use of respiratory syncytial virus vaccine in people aged 60 years of age and older. The CDC recommends that people who have not received the respiratory syncytial virus vaccine and are aged 75 years of age and older receive the respiratory syncytial virus vaccine; and that people who have not received the respiratory syncytial virus vaccine and are aged 60–74 years of age who are at increased risk of severe respiratory syncytial virus, meaning they have certain chronic medical conditions, such as lung or heart disease, or they live in nursing homes, receive the respiratory syncytial virus vaccine. A 2013 study led to the 2023 approval of RSV vaccines. Work on RSV vaccines also supported the rapid development of COVID-19 vaccines. It is on the World Health Organization's List of Essential Medicines.
Medical uses Respiratory syncytial virus vaccine is indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in people 60 years of age and older. Abrysvo is indicated for active immunization for the prevention of lower respiratory tract disease caused by RSV in people 60 years of age and older, high-risk individuals aged 18 through 59 and pregnant individuals at 32 through 36 weeks gestational age to prevent severe disease in their infants from birth through six months of age. Abrysvo is approved for use in pregnant women at 24 through 36 weeks and older adults in the European Union. and between 28 through 36 weeks and older adults in the United Kingdom. Infant-specific issues include the immature infant immune system and the presence of maternal antibodies, which make infantile immunization difficult.
History
Development Attempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)). This early vaccine induced vaccine-associated enhanced respiratory disease (VAERD), in which children who had not previously been exposed to RSV and were vaccinated would develop severe RSV disease if exposed to the virus itself, including fever, wheezing, and bronchopneumonia. Some eighty percent of such children (vs. 5% of virus-exposed controls) were hospitalized, and two children died of lethal lung inflammation during the first natural RSV infection after vaccination of RSV-naive infants. This deadly vaccine failure slowed vaccine development for many years. A 1998 paper reported that research had advanced greatly over the previous ten years. A 2019 paper similarly claimed that research toward developing a vaccine had advanced greatly over the prior 10 years, with more than 30 candidates in some stage of development. The same study predicted that a vaccine would be available within ten years. Candidates included particle-based vaccines, attenuated vaccines, mRNA vaccines, protein subunit vaccines, and vector-based vaccines. A 2013 study detailed the crystal structure of the RSV fusion (F) protein and how its stability could be improved. This provided the basis for finding the most effective F protein constructs, which are used in RSV vaccines. To develop its vaccine, Pfizer engineered 400 different F protein constructs to identify the most immunogenic, and constructed a bivalent RSV prefusion F investigational vaccine. In February 2023, results of a phase III study of around 25,000 participants age 60+ were published. One dose of the Arexvy vaccine provided 94% efficacy against severe RSV pneumonia and 72% efficacy against RSV acute respiratory infection. An advisory panel to the FDA recommended approval of the vaccine in February 2023. In April 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended to grant a marketing authorization for Arexvy for the prevention of RSV lower respiratory tract disease in people 60 years of age or older after review under the EMA's accelerated assessment program. In May 2023, Arexvy was approved for people aged 60 years of age and older, making it the first FDA-approved RSV vaccine. In May 2023, the FDA's expert panel unanimously recommended Abrysvo for approval in pregnant women. The panel was split on the safety of the vaccine in respect of preterm births. In June 2023, Arexvy was authorized for medical use in the European Union. The mRNA vaccine Mresvia was approved for medical use in the United States in May 2024. In June 2024, the FDA approved Arexvy for use in people aged 50 to 59 years of age who are at an increased risk of RSV-caused lower respiratory tract disease. The approval is based on data from a phase III study (NCT05590403), which showed that immune responses were non-inferior in people aged 50–59 years of age at increased risk for RSV disease compared to people aged 60 years of age and older. In October 2024, the FDA approved Abrysvo for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV. Since 2023, Abrysvo has been approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older and for use in pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through six months of age. Abrysvo is manufactured by Pfizer. Mresvia was authorized for medical use in the European Union in August 2024.
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