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Nasal Flu Vaccine Approved

By Michelle Meadows (staff writer for FDA Consumer)

Vaccination is the best way to fight the flu virus, and many people will have an alternative to getting a shot this fall. The FDA has approved the first nasally administered flu vaccine to be marketed in the United States. The needle-free vaccine may be good news for children and others who are reluctant to get a shot.

Experts say FluMist also gives a welcome boost to the flu vaccine supply. "This new vaccine provides another option for protection against influenza and will potentially increase the availability of the injected killed virus vaccine for those people at highest risk," says FDA Commissioner Mark B. McClellan, M.D., Ph.D.

Like the injected flu vaccine, each FluMist dose contains the three influenza strains recommended for the 2003–2004 season. FluMist is the first live virus influenza vaccine to be approved in the United States. The strains of live virus are modified so they don't grow efficiently at body temperature, but replicate enough to produce immunity.

"Because it is live, it can grow in the nose and some people get flu symptoms, though usually milder than natural influenza," says Chris Anna Mink, M.D., a medical officer in the FDA's Center for Biologics Evaluation and Research. The most common side effects associated with FluMist are nasal congestion, runny nose, sore throat, and cough.

"So far, the vaccine seems to be very safe in the healthy people we've tested," says Paul Glezen, M.D., a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who has run FluMist clinical trials. "But we haven't tested the vaccine in people who are immunocompromised."

As with other live virus vaccines, FluMist should not be given to people with immune suppression, such as people with AIDS or cancer. The vaccine also shouldn't be given to pregnant women, people with a history of asthma or other reactive airway diseases, people age 50 and over, or to children under 5. People who have ever had an allergic reaction to eggs or to a previous dose of the flu vaccine shouldn't take any kind of flu vaccine.

Flu symptoms include fever, headache, extreme fatigue, dry cough, sore throat, runny or stuffy nose, and muscle ache. "Flu is generally more likely to have sudden onset than colds, which tend to come on gradually," Glezen says. Flu also has more severe symptoms and complications than colds. "The most common flu complications are middle ear infections, sinusitis, and bronchitis. Rarer complications--but ones that are more serious--include pneumonia and dehydration."

According to the Centers for Disease Control and Prevention (CDC), about 10 percent to 20 percent of U.S. residents come down with the flu each year. About 114,000 people are hospitalized for flu-related complications, and there is an annual average of 36,000 deaths. Most people get vaccinated in October and November, but the flu vaccine can still provide protection when used in December and January. The CDC recommends that people in high-risk groups and people who come into contact with high-risk groups get a flu vaccine every year. Rates of flu infection are highest in children ages 5 to 14, and the most severe illnesses and deaths occur in people with underlying medical conditions, children under 2, and people over age 65. Because the safety of FluMist has not been established in high-risk individuals, they should get the injected killed virus flu vaccine.

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About FluMist

FluMist (Influenza Virus Vaccine Live, Intranasal), which is sprayed into both nostrils, is approved to prevent disease caused by influenza viruses in healthy children and adolescents ages 5 to 17 and in healthy adults ages 18 to 49. People ages 9 to 49 need one dose, and children ages 5 to 8 need two doses at least six weeks apart the first year they get the vaccine. In clinical trials, FluMist was tested in roughly 20,000 people, including more than 10,000 healthy children 5 to 17 years of age. The vaccine is manufactured by MedImmune Vaccines Inc. of Gaithersburg, Md., and will be marketed by MedImmune and by Wyeth Vaccines of Philadelphia.

Reprinted from FDA Consumer. This article originally appeared in the September-October 2003 FDA Consumer.

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