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| Vol. 20, No. 10 |
| June 1, 1998 |
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Nasal Spray Flu Vaccine Effective The results of a nationwide study published in the May 14 issue of The New England Journal of Medicine show that a nasal spray flu vaccine is highly effective at preventing both the flu and flu-related ear infections in children. The vaccine proved 93 percent effective against influenza and 98 percent effective against flu-related ear infections, or otitis media. "As a pediatrician and an investigator in this area, I was very pleased with the data that came from the multi-center study," says Dr. Pedro A. Piedra, principal investigator for the research conducted at Baylor College of Medicine, one of 10 clinical sites participating in the study. The Baylor portion of the study, which saw 216 enrollees, was conducted primarily at Houston-area Kelsey-Seybold clinics. A total of 1,602 children from 15 months of age up to 6 years old were enrolled in the study conducted during the 1996-1997 flu season; 1,070 received the vaccine in either one or two doses and 532 received a placebo. Of those given the vaccine, only 14 (1 percent) developed culture-confirmed influenza and only one child in that group of 14 presented with a related ear infection. Comparatively, 95 of the 532 (18 percent) who were given the placebo developed influenza, while 20 of the 95 influenza cases also had a related earache. In recent years, bacteria have developed resistance to many of the common antibiotics used to treat ear infections, according to Dr. Piedra, a pediatrician at Baylor's Influenza Research Center and an attending physician at Texas Children's Hospital. "If we can prevent ear infections and reduce the use of antibiotics, hopefully, we'll be able to reduce the high resistance that common bacteria have to antibiotics," he says. "There have been studies demonstrating that children contribute to the spread of flu in families and communities," says Dr. Piedra. "By reducing influenza in children, hopefully we can reduce the spread of influenza in the community." Dr. Piedra says that approximately 30 percent of children get the flu each season. The nasal spray vaccine is made from live but weakened influenza viruses. These viruses grow in the cooler temperatures of the nasal passage to build up immunity to influenza. The vaccine, called FluMist', is being developed under a cooperative research agreement between the National Institute of Allergy and Infectious Diseases (NIAID) and Aviron, a biopharmaceutical company in Mountain View, Calif. Aviron expects to submit an application to the Food and Drug Administration by mid-1998 to license FluMist' for use in children and healthy adults. Pending FDA approval, the company intends to have the vaccine ready for the fall 1999 flu season. NIAID, one of the National Institutes of Health, and Aviron co-sponsored the study. In addition to Baylor, NIAID sponsored Vaccine and Treatment Evaluation Units at Saint Louis University (lead center), Harbor-UCLA Research and Education Institute, the University of Rochester School of Medicine and Dentistry, Children's Hospital Medical Center in Cincinnati, and the University of Maryland Medical Center in Baltimore. Four sites were sponsored by Aviron: Kentucky Pediatric Research, Inc. in Bardstown, Ky.; Pittsburgh Pediatric Research; the University of Virginia, and Vanderbilt University in Nashville, Tenn.
- From the National Institutes of Health, with additional reporting by
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