Nose Spray Vaccine for Kids Outdoes Flu Shots in Test
By Steve Johnson, San Jose Mercury News, Calif.
May 02–Here’s a dose of good news: A new version of nose-spray vaccine developed by a Mountain View company may be better than flu shots at protecting young children and babies from flu, according to a new study.
The study of 8,475 children in 16 countries, presented Monday at the annual meeting of the Pediatric Academic Societies in San Francisco, found a new nasal spray was 55 percent more effective in preventing flu symptoms than flu shots. The spray is made by MedImmune of Gaithersburg, Md., which bought the Mountain View company that developed the spray vaccine.
Among the children receiving a flu shot during the 2004 flu season, 8.6 percent later developed the flu, according to the study. By contrast, only 3.9 percent of those getting the nasal spray got sick.
“It’s certainly a reasonable addition to our armament against influenza,” said Dr. George Rutherford, a professor of epidemiology and preventive medicine at the University of California-San Francisco, who was not involved in the study. “There is this large reservoir of unvaccinated, untreated kids who can transmit the disease.”
Public health authorities would welcome a more effective vaccine. Each year, an average of 200,000 people are hospitalized and about 36,000 people die because of the flu. The elderly and children under 2 are particularly vulnerable.
Vaccines now on the market don’t work as well on young children as they do on older people. Also, children tend to be more likely to spread the flu to others.
“The findings are incredibly important,” said Dr. Robert Belshe, director of the Center for Vaccine Development at the Saint Louis University School of Medicine, who chaired the study’s advisory committee. Belshe was a paid consultant to MedImmune, which financed the study.
“It says we have a way of preventing a lot more flu using the nasal spray,” Belshe added. “It gives pediatricians a tool to improve the control of flu.”
MedImmune has the only nasal spray vaccine on the market. Its current version, FluMist, initially was developed by Aviron of Mountain View, which MedImmune bought for more than $1 billion in 2001.
Because of concerns about some children under 5 being slightly more likely to wheeze after taking FluMist, the U.S. Food and Drug Administration limited the drug’s use to children over 5 when it approved its sale in 2003. The new version of the drug, dubbed CAIV-T, also resulted in a small but disproportionate number of wheezing cases among the youngest subjects in the recent international study.
In the study reported Monday, a total of 55 children receiving CAIV-T suffered wheezing compared with 34 who got the vaccine shot, Belshe said. As a result, additional tests will be done to assess CAIV-T’s safety.
MedImmune executives have said they plan to ask the FDA by the end of June for approval to sell the newly formulated nasal spray to children as young as 6 months. If the wheezing problem is determined to be significant, Belshe said, the company may not seek approval to use the drug on children under 2.
Belshe and MedImmune partly attributed the unusual effectiveness of CAIV-T to its being made from live but weakened influenza virus, unlike injected vaccines. In addition, they said, the drug is sprayed in the nose, offering protection in the very spot where the flu virus usually enters the body.
CAIV-T also has another potential big advantage over FluMist. It can be kept in a refrigerator, instead of having to be frozen as required for the first-generation FluMist.
MedImmune is counting on the positive study data and the fact that CAIV-T is relatively easy to store to help boost the company’s revenue. FluMist has suffered lagging sales recently, tumbling from $48 million 2004 to $21 million last year.
“This is very exciting data,” said George Kemble, MedImmune’s vice president for research and development, who is based in Mountain View. “It gives us a chance to really make a positive impact on health care.”
Contact Steve Johnson at sjohnson@mercurynews.com or (408) 920-5043.
—–
Copyright (c) 2006, San Jose Mercury News, Calif.
Distributed by Knight Ridder/Tribune Business News.
For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.
NASDAQ-NMS:MEDI,