07 December, 2005 20:37 GMT
Past shortages of injectable flu vaccine might have led some doctors to give FluMist to patients for whom it is not approved. Some may have thought the risks associated with the flu outweighed the risks from the vaccine.
Few serious side effects have been reported since the inhaled flu vaccine FluMist became available nationwide two years ago. About 2.5 million people in the United States have received FluMist, manufactured by
MedIummune Inc., which is intended for healthy people ages 5 to 49.
Of 460 "adverse events" possibly linked to the vaccine and voluntarily reported to the US Vaccine Adverse Event Reporting System (VAERS) through August, 40 were considered serious, including breathing problems in asthma patients and life-threatening allergic reactions.
The figures echo previous reports about FluMist's safety and show that the vaccine is safe when used as directed, government researchers said.
The study appears in Wednesday's
Journal of the American Medical Association. It was conducted by researchers from the
Food and Drug Administration and the
Centers of Disease Control and Prevention. The agencies operate the VAERS system.
Live but Weakened Influenza Virus
Unlike flu shots, FluMist contains live but weakened influenza virus -- the reason it is not recommended for people at highest risk for flu complications, such as the elderly, children and people with asthma or other chronic diseases.
Overall, there were 73 reports of possible side effects in patients who should not have been given FluMist in the first place. Eight of the 12 reported asthma cases happened in patients with a history of asthma.
Past shortages of injectable flu vaccine might have led some doctors to give FluMist to asthmatics and other patients for whom it is not approved, said Dr. Gary Noskin, chief of epidemiology at Northwestern Memorial Hospital in Chicago. Some may have thought the risks associated with the flu outweighed the risks from the vaccine, Noskin said.
'System Is Working'
The number of cases of improper use "is really a small subset -- it shows that the system is working," said the study's leader author, Dr. Hector Izurieta of the FDA. "I don't think it suggests people are using it in an arbitrary way."
No vaccine shortages are expected this flu season.
FluMist, introduced in 2003, is thought to work at least as well as injections at preventing flu.
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