- The Washington Times - Wednesday, December 18, 2002

A long-awaited pain-free flu vaccine one squirted up noses instead of injected into arms took a tentative step toward the market yesterday even as government scientists said FluMist is safe enough for only some people to use.
But FluMist, made by Gaithersburg-based Medimmune Inc., has not proved to be safe for the people who most need a flu vaccine or a pain-free option toddlers, the elderly and anyone with asthma or other chronic diseases, advisers to the Food and Drug Administration said.
Indeed, FluMist initially was created with the hope of giving toddlers a needle-free vaccine, but researchers discovered it seems to increase the risk of asthma attacks in children under age 5.
So in its second attempt at winning FDA approval in two years, the vaccine's maker withdrew its plans to sell FluMist for toddlers, saying it would instead target healthy people ages 5 to 64.
The FDA's advisers threw a hurdle in the path of the new plan yesterday recommending approval only for those ages 5 to 49. They concluded there is too little evidence that FluMist protects people 50 and over, an age when the immune system begins to wane.
Now the question is whether the FDA, which isn't bound by its advisers' recommendations, will let a vaccine with so many restrictions be sold. If so, the uncertainties would severely limit how often doctors offer FluMist instead of the flu shots that 70 million Americans get every year.
A big unanswered question: Is FluMist as good as that standard flu shot? After all, FluMist is made of a weakened but live flu virus, while today's flu shots are made of killed virus. MedImmune hasn't compared the two vaccines.
Calling that question "the elephant in the room," FDA adviser Dr. Julie Parsonnet of Stanford University complained that without such data, doctors won't know which product to offer which patient if FluMist does sell.
"They are issues that are going to be highly problematic," agreed Dr. Dixie Snider of the Centers for Disease Control and Prevention.
Flu kills 20,000 Americans each year and hospitalizes 100,000. Those most at risk of flu complications, and thus who most need vaccine, are those over age 65 and people with certain illnesses including asthma and heart disease.
Also, this year for the first time, pediatricians are being encouraged to vaccinate babies and toddlers, who are hospitalized with flu as often as the elderly and are key spreaders of infection through day care and to elderly grandparents.
Flu experts have longed for a needle-free alternative as a way to persuade more people to get annual flu vaccinations.
The nasal vaccine works by stimulating the immune system through the same nose tissue where the flu virus attacks. But in July 2001, FDA's advisers blocked FluMist's sale by saying the vaccine wasn't yet proved safe for children.
Yesterday, MedImmune argued its case again.
The vaccine proved 93 percent effective in preventing the flu in a study of 1,600 healthy children ages 15 months to 6 years old. Side effects included runny nose, muscle aches and fever, expected from exposure to weakened flu virus.
But up to 1.5 percent of children under age 5 who received FluMist suffered asthma attacks or asthmalike wheezing, rates almost four times higher than children who received a dummy vaccine, the FDA said.

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