FDA approves first nasal mist flu vaccine.

2003 JUL 9 - (NewsRx.com & NewsRx.net) -- Most people who avoid flu shots because they fear needles will not have that excuse this season.

The U.S. Food and Drug Administration (FDA) 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 (MedImmune Vaccines, Inc.), was approved June 17, 2003, by the FDA for healthy people ages 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 5 to 8, the first exposure to FluMist requires 2 doses 6 weeks apart. Patients ages 9 to 49 need only 1 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 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 be vaccinated against flu.