Originally Released: May, 1998
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A study published today in the New England Journal of Medicine shows that a nasal spray flu vaccine effectively prevents the flu in children. The study, which also found the vaccine to be effective at preventing ear infections associated with influenza, was conducted in Baltimore at the University of Maryland Medical Center and in nine other cities nationwide.
"This vaccine is a major breakthrough in the effort to immunize children against influenza without the fear and pain of a shot," says James King, M.D., a pediatrician at the University of Maryland Medical Center and associate professor at the University of Maryland School of Medicine. Dr. King, who is a co-author of the article, also says, "Children who received the vaccine had 93 percent fewer cases of influenza than the children who received a placebo."
The vaccine study enrolled 1,602 children ranging in age from 15 months to 6 years old. Researchers enrolled healthy young children for the study. Those children experience the highest incidence of influenza and are a major source of its spread.
At the University of Maryland Medical Center, 110 children took part in the study. Two-thirds of the children received the nasal flu vaccine, and one-third received a placebo.
Only one percent of the 1,070 children who received the vaccine developed culture-confirmed influenza during last year's flu season, compared to 18 percent of 532 children the same age who received a placebo. The researchers also found that the nasal flu vaccinations reduced the incidence of influenza-related complications, such as ear infections accompanied by fever. There was also a decreased use of antibiotics in the group that was vaccinated, which is important because of concern over the emergence of bacteria resistant to antibiotics.
"Our study found the vaccine to be safe and well-tolerated, and we believe it may have a significant public health impact in preventing flu illnesses within families and the community at large," says Karen Kotloff, M.D., a pediatrician at the University of Maryland Medical Center and associate professor at the University of Maryland School of Medicine who is also a co-author of the study. "Since this vaccine does not require a shot, it is likely to be much more widely accepted," Dr. Kotloff added.
The new vaccine is made from a weakened influenza virus. While it cannot cause influenza, it is designed to stimulate antibodies in the nasal passage that protect against naturally acquired infection. As with the current licensed vaccine given by injection, the new nasal spray vaccine contains two strains of influenza A and one strain of influenza B.
The flu affects up to 50 million people a year in the United States. Epidemics usually occur between late fall and early spring. More than 20,000 people die from influenza and its complications each year. An estimated $4.6 billion is spent annually on direct medical costs related to influenza. By the age of five, many children have had the flu at least three times.
The study was co-sponsored by the National Institute of Allergy and Infectious Disease (NIAID), one of the National Institutes of Health, and Aviron, a biopharmaceutical company in Mountain View, California. The company has named the new product FluMist.
"This is the only nasal vaccine shown in a large study to be effective in preventing an illness," says Dr. Kotloff. "The next step would be for Aviron to apply to the FDA for licensure. If that occurs, the vaccine could be available by the fall of 1999," she adds.
The study was conducted at NIAID-sponsored Vaccine and Treatment Evaluation Units at the University of Maryland Medical Center in Baltimore, St. Louis University (the lead center), Baylor College of Medicine, Harbour-UCLA Research and Education Institute, the University of Rochester, Children's Hospital Medical Center in Cincinnati and at four Aviron-supported sites included Vanderbilt University in Nashville, TN, the University of Virginia, Charlottesville, VA, the Pittsburgh Pediatric Research Center in Pittsburgh, PA and at a practice in Bardstown, Kentucky.
The six VTEUs are part of a network of university-based sites funded by the NIAID to conduct research into new and improved vaccines against major childhood and adult diseases. Scientists at the University of Michigan, NIH and Aviron developed the new vaccine.
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