Directories
Quick Searches
Find a Job
Quick Search
For Employers
Yahoo! HotJobs Local Search
Health advisers say MedImmune nasal spray flu vaccine merits approval for use in toddlers
By: Associated Press - | ∞
WASHINGTON -- Toddlers may soon be able to get their flu vaccine by a spritz to the nose instead of a jab to the skin.
Federal health advisers unanimously agreed Tuesday a nasal spray flu vaccine both is safe and works in children 2 and older. The vaccine, made by MedImmune Inc., is called FluMist.
FluMist is currently approved for use in healthy people ages 5 to 49. The Gaithersburg, Md. company seeks expanded Food and Drug Administration approval for use in children ages 1 to 5 without a history of wheezing or asthma.
The health advisers offered a series of opinions on use of the drug for the youngest children and in cases of wheezing children.
Expert advisers to the FDA:
--Narrowly agreed on a 9-6 vote Tuesday the nasal spray vaccine merits approval for use in children as young as 1 -- but again, only if they don't wheeze.
--Agreed by 15-0 that if a child does wheeze, the vaccine should be used only in those 2 and older.
--Voted 12-3 against recommending use in wheezy children younger than 2.
The FDA isn't required to follow the advice of its outside panels of experts but usually does.
A MedImmune official said the only unambiguous recommendation to the FDA was on the vaccine's use in those 2 and older.
"The question remaining is how the FDA ultimately will rule on children under 2," said Dr. Edward Connor, MedImmune's chief medical officer, following the meeting.
Even a limited potential for the vaccine to increase the risk of respiratory problems in the very young is a concern. Wheezing and asthma can lead to shortness of breath, respiratory distress and, potentially, death.
The FDA originally approved FluMist in 2003. Last month, MedImmune agreed to be purchased by British drug maker AstraZeneca PLC for $15.6 billion.
More Stories
- Boston suburb goes on diet to curb childhood obesity
- Health advisers say MedImmune nasal spray flu vaccine merits approval for use in toddlers
- Prominent federal ethicist says U.S. health care system is 'dysfunctional mess'
- New test promises to reveal sex of fetus 6 weeks into pregnancy
- Studies show experimental smallpox vaccine nearly as good as older vaccine
Advertisement
- ESCONDIDO: Man shot dead at Fourth of July party (10602)
- TEMECULA: Protesters line intersection (6597)
- ESCONDIDO: 3 DUI arrests, 46 impounds at checkpoint (5389)
- ESCONDIDO: Border Patrol employee in custody after hatchet attack (5312)
- ESCONDIDO: City's dreams of an 'upscale' downtown may be dying (4975)
- HOUSING: Local median price up for third straight month (45)
- ESCONDIDO: Man shot dead at Fourth of July party (44)
- FALLBROOK: Peruvian chocolatier living sweet American dream (29)
- ESCONDIDO: Border Patrol employee in custody after hatchet attack (29)
- ESCONDIDO: Victim's roommate recalls July 4 shooting, friends gather for vigil (27)
Advertisement