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Nasal Spray Flu Vaccine Given FDA Approval

June 18, 2003|From Associated Press

WASHINGTON — A flu vaccine that is the first to be delivered by a squirt into the nose instead of a needle in the arm has been approved by the Food and Drug Administration for healthy people ages 5 to 49.

The vaccine, FluMist, was approved by the FDA even though it was given only a tentative endorsement by an advisory panel in December.

The panel said the drug would not be appropriate for people who most need vaccine protection from influenza: toddlers, the elderly and people with asthma or other chronic diseases.

Children ages 5 to 8 require two doses of FluMist six weeks apart. Patients 9 to 49 need only one dose, the agency said.

The safety and effectiveness of FluMist has not been proved for people 50 and older. The FDA encouraged those patients to get the injected flu vaccine.

FluMist was not approved for children under 5 because in clinical trials researchers found that young children treated with the nasal mist vaccine had a higher rate of asthma attacks and wheezing within 42 days of the vaccination, compared with children who received a placebo.

Approval of FluMist achieves a goal of many flu experts: a needle-free alternative to the annual shot. Some believe this may encourage more people to become vaccinated against flu.

FluMist contains each of the three influenza live virus strains that scientists expect will be active during the 2003-2004 flu season.

These include two types of influenza A, which causes severe illness, and one type of influenza B, which causes a milder form of the disease. Influenza is the cause of 36,000 deaths annually in the United States.

Most of the victims are patients with other health problems, children under 2 and people over 65.

FluMist is manufactured by MedImmune Vaccines Inc. of Gaithersburg, Md. A company spokesperson said the firm is now taking orders for the drug and that 4 million to 6 million doses will be available by October, the start of the flu season.

The company said FluMist will cost about $46 a dose, more than twice the typical cost of injected flu vaccine.

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