Recommended use of palivizumab to reduce complications of respiratory syncytial virus infection in infants

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Organization: Public Health Agency of Canada

Published: June 2022

Summary of information contained in this NACI statement

The following highlights key information for immunization providers. Please refer to the remainder of the Statement for details. The full-text of the statement is available in PDF format. To obtain the report in an alternative format, please contact us by email at naci-ccni@phac-aspc.gc.ca.

What

a) Respiratory syncytial virus disease

Respiratory syncytial virus (RSV) causes yearly outbreaks of respiratory tract disease, in Canada from late fall to early spring. It is the most common cause of lower respiratory tract illness in young children worldwide. While many infections are simple colds, children less than 2 years of age are at risk of severe disease such as bronchiolitis or pneumonia and may be hospitalized. Underlying health conditions, especially premature birth, chronic lung disease and congenital heart disease (CHD) redispose to severe RSV illness. Reinfections occur throughout life as infection produces only partial and temporary immunity, although reinfections are usually milder than the initial one. 

b) Palivizumab

At present there is no vaccine available to prevent RSV. The only means of prophylaxis against RSV disease is temporary passive protection with the monoclonal antibody preparation Palivizumab (SynagisTM). Palivizumab (PVZ) has only been studied in children less than 2 years of age with underlying health conditions. Efficacy in early studies was 38-78% in different patient groups, and further studies, mainly observational, showed wide variation in effect with some studies showing no benefit. PVZ has been used for over 2 decades in many countries and has a good safety record, with very rare cases of anaphylaxis being the major serious adverse event (SAE). It is an expensive product, with wide ranging estimates of cost-effectiveness (or value for money). Estimated incremental effectiveness ratios (ICERs) ranged from less than $1,000 per quality-adjusted life year (QALY) to over 2 million dollars per QALY in various scenarios. In various high risk groups, 64% to 100% of estimates were < $50,000 per QALY. In rare scenarios it may be dominant (i.e, less costly and more effective). RSV vaccines are currently under study.  

Who

NACI makes the following recommendations for public health program level decision-making:

Since in Canada PVZ is not readily available for purchase, no specific recommendations are made for individual-level decision making.  

How

Why

PVZ is recommended for infants and young children with health conditions that make them more vulnerable to severe RSV disease requiring hospitalization and possibly admission to an intensive care unit and mechanical ventilation.

Although the risk of severe RSV disease is reduced, PVZ does not prevent all hospitalizations for RSV. It is thought to prevent 40 to 80% of hospitalizations, depending on age and underlying health condition. Therefore other means of protection against RSV (limiting exposure of high risk children to persons with cough and colds, appropriate hand hygiene, preventing exposure to cigarette smoke) are important.

Although any young child may be hospitalized with RSV, most will not have severe illness. PVZ is not recommended for children at lower risk of severe disease, in some instances because of cost, in others because of lack of information about whether it will work.

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