Doubts Raised On Pain-Free Vaccine
December 18, 2002
Associated Press
WASHINGTON -- A long-awaited pain-free flu
vaccine - one squirted up noses instead of injected into arms - took
a tentative step toward the market Tuesday even as government
scientists said FluMist is safe enough for only some people to use.
But FluMist is not proved 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 stressed.
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 aged 5 to 64.
The FDA's advisers threw a monkey wrench into the new plan Tuesday -
recommending approval only for those aged 5 to 49. They concluded
there's 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 is not bound by its
advisers' recommendations, will let a vaccine with so many
restrictions sell. 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. Manufacturer
MedImmune Inc. hasn't compared the two vaccines.
Flu kills 20,000 Americans each year and hospitalizes 100,000.
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OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"