FDA approves sale of first nasal mist flu vaccine

WASHINGTON -- Most people who avoid flu shots because they fear needles will not have that excuse this season. The Food and Drug administration has approved a flu vaccine that is delivered by a squirt up the nose instead of a shot in the arm.

The vaccine, called FluMist, was approved Tuesday by the FDA for healthy people age 5 to 49, but not for people who often are in most need of protection from the flu: toddlers, the elderly and people with asthma or some other chronic diseases.

For children from 5 to 8, the first exposure to FluMist requires two doses six weeks apart. Patients from 9 to 49 need only one dose, the agency said.

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

FluMist was not approved for patients 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 to 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 be vaccinated against flu.

FluMist contains each of the three influenza live virus strains expected to 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. The live virus in the vaccine has been weakened so that it produces immunity without causing illness.