FDA Approves FluMist For Children Ages 2 to 5

FluMist manufacturer MedImmune plans to produce about 4.5 million FluMist doses this flu season. The company spent $100 million on a study that showed FluMist was 55 percent more successful than flu shots at protecting children from influenza. (By Chris Gardner -- Associated Press)

MedImmune has cleared a significant hurdle to revive its long-troubled nasal flu vaccine, announcing yesterday that the Food and Drug Administration had approved FluMist for children 2 to 5 years old.

The Gaithersburg firm had been limited to selling FluMist for people ages 5 to 49, missing a needle-averse market targeted by federal heath officials for yearly vaccines. Only one company, Sanofi Pasteur, has been approved to provide children under 4 with flu shots, which poses a potential public-health catastrophe if manufacturing problems occur.

MedImmune sees FluMist as not only an improved delivery method but also a better way to protect children. It spent $100 million on a study that showed FluMist was 55 percent more successful than flu shots at protecting children from influenza. The results were used to support MedImmune's expanded approval application, though the FDA is not allowing use of FluMist for children under 2, who had more side effects.

MedImmune executives, who have been criticized by analysts and investors over their handling of FluMist since its launch in 2003, hailed the approval as a positive development for children's health that can also help protect the adult population from a serious and sometimes deadly virus.

"We've gone after a population that is at significant risk," said Frank Malinoski, MedImmune senior vice president of medical and scientific affairs. "And it's a population that likes to play together and has runny noses and spreads the virus."

Earlier this year, MedImmune, a subsidiary of AstraZeneca, cleared another hurdle in gaining wider adoption of FluMist, winning federal approval for a refrigerated version. The vaccine previously needed to be frozen, a deterrent for many doctors, pharmacists and school vaccine administrators who store flu shots in refrigerators. Malinoski previously said, "You don't even get in the door with the frozen formulation with a lot of groups."

MedImmune's announcement of the wider approval came as health experts were holding a news conference at the National Press Club to discuss the availability of flu vaccine this year and to urge that millions more Americans be immunized. Several speakers got notice of the approval on their BlackBerrys during the event.

"This is very good news," said Julie Gerberding, director of the Centers for Disease Control and Prevention. "It's just another sign of the stabilization of the vaccine supply."

Federal health officials said 132 million flu vaccine doses will be available this flu season. MedImmune said it will produce about 4.5 million FluMist doses, instead of a previously expected 7 million. The reduction is caused in part by manufacturing problems that delayed shipment of the product. The issues were recently solved to the FDA's satisfaction.

MedImmune will sell FluMist for $17.95 a dose, which is slightly more expensive than flu shots but far less costly than the more-than-$40 a dose the company charged in 2003. The price reduction is partially offset by an increase in the number of potential customers because of the FDA's wider approval. Malinoski said the number could be as high as about 10 million but said 5 million is more realistic.

MedImmune now awaits the recommendation of a Centers for Disease Control and Prevention panel that advises hospitals and doctors on which vaccines to use and how to use them. The panel does not meet again until next month but could hold a vote earlier by phone.

Henry Bernstein, a New Hampshire pediatrician and member of the Committee on Infectious Diseases of the American Academy of Pediatrics, said yesterday that he planned to offer FluMist and flu shots to his patients. "I think it's an important addition to the influenza vaccine supply," he said. "It can be administered not by injection, which is great for some families. It has good efficacy in young children, and being able to administer it [to children] down to two years is great."

Staff writer Susan Levine contributed to this report.