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RSV vaccine remains an elusive target
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Less than a month after the FDA’s Antiviral Drugs Advisory Committee voted against marketing approval for motavizumab, officials with the Advisory Committee on Immunization Practices discussed other options for preventing respiratory syncytial virus.
FDA advisory panel officials stated that more data were needed on motavizumab (MEDI-524, MedImmune) regarding safety, efficacy and indications before it could achieve licensure after a 14-3 vote in June of 2010. FDA panel members were cautious due to motavizumab’s association with hypersensitivity.
Cody Meissner, MD, a member of the ACIP’s RSV working group, told the committee that a vaccine to protect against RSV would be ideal, especially one that would be administered early in life.
Gayle Fischer Langley, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Disease, said that most children with RSV present with upper-respiratory tract infections (URTI) such as rhinitis, but an additional 20% develop lower-respiratory tract infections (LRTI) as well.
She noted that almost all symptomatic infections — about 70% — are likely to develop within the first year. Reinfection is common but milder. RSV season peaks between the months of November and April.
Fischer Langley told the committee that RSV accounts for about 500 deaths, 57,000 to 125,000 hospitalizations, 500,000 emergency room visits and 1.5 million outpatients visits for children younger than age 5 each year. She added that 16.9 per 1,000 cases occur between the ages of birth and 5 months and 5.1 per 1,000 cases occur between the ages of 6 and 11 months.