RSV work group aims to develop immunoprophylaxis guidance for ACIP

The burden of respiratory syncytial disease is increasing, and the options for passive antibody protection may soon expand. To address these two issues, the Advisory Committee on Immunization Practices has formed a work group to examine RSV disease and the data on immunoprophylaxis options, according to ACIP member Lance Chilton, MD.

The percent of infant hospitalizations in the United States related to RSV jumped from 5.4% in 1980 to 16.4% in 1996 and RSV complications lead to about 200 to 500 deaths per year. As supportive care for RSV is the main treatment option for this illness, passive antibody protection has taken center stage as a way to prevent RSV, Chilton told the ACIP yesterday.

Recently, the AAP’s Committee on Infectious Diseases recommended major changes in the recommendations for immunoprophylaxis of infants with a gestational age between 32 weeks and 35 weeks, namely that eligibility for this gestational age group be modified to include only those infants younger than 3 months of age (previously 6 months) at the onset of RSV season or those born during RSV season and who have one of two risk factors.

A BLA has been submitted to the FDA for motavizumab, MedImmune’s investigational monoclonal antibody (MAb) that is being evaluated for its potential to prevent serious disease caused by RSV in high-risk pediatric patients.

Following in the AAP COID’s footsteps and anticipation of motavizumab’s licensure, the ACIP formed its own work group on RSV. Chilton said the goal of their workgroup is to gather safety and efficacy data to develop evidence-based recommendations for RSV immunoprophylaxis.

He said their group plans to look at seasonality and the environment as risk factors for severe disease, and examine the evidence on prophylaxis, including data on palivizumab (Synagis, MedImmune) and motavizumab, and draft recommendations for the ACIP’s consideration.