What are the recommendations for RSV (Respiratory Syncytial Virus) vaccination or prophylaxis, such as palivizumab (palivizumab), in high-risk individuals?

From the Guidelines

RSV prophylaxis recommendations focus primarily on high-risk populations, with palivizumab (Synagis) being the main preventive medication for high-risk infants and children, and newer options like nirsevimab (Beyfortus) and RSV vaccines (Arexvy and Abrysvo) available for adults and pregnant women. The priority recipients for palivizumab include premature infants born before 29 weeks gestation, infants under 12 months with chronic lung disease of prematurity requiring medical therapy, and children under 24 months with hemodynamically significant congenital heart disease 1. Children with neuromuscular disorders, immunocompromised status, or Down syndrome may also qualify for palivizumab prophylaxis 1. For adults, nirsevimab (Beyfortus) is a long-acting monoclonal antibody given as a single dose that provides protection throughout RSV season, and RSV vaccines (Arexvy and Abrysvo) are recommended for adults 60+ and pregnant women between 32-36 weeks gestation to protect newborns 1. These interventions are crucial because RSV can cause severe lower respiratory tract infections in vulnerable populations, with high-risk individuals facing increased chances of hospitalization, respiratory failure, and mortality 1. Prophylaxis timing should align with local RSV season patterns, and healthcare providers should assess individual risk factors when determining eligibility. Some key points to consider include:

• Palivizumab is administered as monthly intramuscular injections (15 mg/kg) during RSV season, which typically runs from November to April in the Northern Hemisphere 1.
• Nirsevimab (Beyfortus) is a long-acting monoclonal antibody given as a single dose that provides protection throughout RSV season 1.
• RSV vaccines (Arexvy and Abrysvo) are recommended for adults 60+ and pregnant women between 32-36 weeks gestation to protect newborns 1.
• Healthcare providers should assess individual risk factors when determining eligibility for RSV prophylaxis 1. It is essential to note that the recommendations for RSV prophylaxis may vary depending on the specific population and risk factors, and healthcare providers should consult the latest guidelines and evidence-based recommendations when making decisions about RSV prophylaxis.

From the FDA Drug Label

The safety and efficacy of Synagis were assessed in two randomized, double-blind, placebo-controlled trials of prophylaxis against RSV infection in children at high risk of an RSV-related hospitalization Trial 1 was conducted during a single RSV season and studied a total of 1502 children less than or equal to 24 months of age with BPD or infants with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry Trial 2 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease

The recommendations for RSV vaccination or prophylaxis in high-risk individuals are as follows:

• Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease, such as those with bronchopulmonary dysplasia (BPD) or premature infants [ 2 ].
• The dosage of palivizumab is 15 mg/kg administered via intramuscular injection monthly for five injections [ 2 ].
• High-risk individuals include children less than or equal to 24 months of age with BPD or premature infants less than or equal to 35 weeks gestation, as well as those with hemodynamically significant congenital heart disease [ 2 ].
• The clinical studies demonstrate a reduction in RSV hospitalization in high-risk individuals who received palivizumab compared to those who received placebo, with a relative reduction of 55% in Trial 1 and 45% in Trial 2 [ 2 ].

From the Research

RSV Vaccination and Prophylaxis Recommendations

• The American Academy of Pediatrics recommends palivizumab prophylaxis for high-risk infants, including those with prematurity (less than or equal to 35 weeks) or bronchopulmonary dysplasia (BPD) 3, 4.
• Palivizumab has been shown to reduce hospitalization due to RSV infection by 55% in high-risk infants 3.
• The use of palivizumab is preferred over RSV-IGIV due to its ease of administration, lack of interference with measles-mumps-rubella vaccine and varicella vaccine, and lack of complications associated with intravenous administration of human immune globulin products 4.
• Restrictive use of palivizumab in pediatric hematopoietic stem cell transplantation patients did not lead to increased morbidity and mortality, and resulted in significant dose and cost savings 5.
• A Cochrane review found that palivizumab reduces hospitalization due to RSV infection, and probably results in little to no difference in mortality or adverse events 6.

High-Risk Individuals

• High-risk individuals, including those with prematurity, BPD, and certain congenital heart diseases, may benefit from palivizumab prophylaxis 3, 4.
• The American Academy of Pediatrics recommends considering prophylaxis for children younger than 24 months who are profoundly immunocompromised during the RSV season 5.
• Palivizumab may also be beneficial for older adults and other vulnerable populations, although its use is currently limited due to logistical issues 7.

Future Directions

• Further research is needed to establish the effect of palivizumab on children with other comorbidities known as risk factors for severe RSV disease, as well as its use in low- and middle-income countries 6.
• The development of new prophylaxis strategies, such as adeno-associated virus vector-mediated expression of antirespiratory syncytial virus antibody, may provide alternative options for preventing RSV infection in high-risk individuals 7.