Most kids can't stand getting mandatory vaccine shots, making it tough for parents to subject them to voluntary ones. But a move by the Food and Drug Administration yesterday means needles are no longer required - at least when it comes to preventing the flu.
The regulatory agency approved a new version of the nasal spray vaccine FluMist for use in children age 2 to 5. The development potentially boosts Gaithersburg manufacturer MedImmune Inc.'s patient base, and bottom line, by millions.
The old FluMist was approved in 2003 for use only in healthy people ages 5 to 49, though the company had sought approval for ages 1 through 64. Analysts blamed the midrange age restriction in part for the vaccine's previously poor sales, along with its frozen formulation, which makes it difficult to store and administer, and poor marketing. FluMist accounted for about 3 percent - $36 million - of MedImmune's revenue last year.
The company is counting on its new refrigerated version, bolstered sales efforts and the expanded age label granted yesterday to boost revenue and the likelihood that more children get vaccinated.
"The FDA approval of FluMist for young children is important because these young kids have very high attack rates for influenza, often require medical evaluation for their influenza illness, and can spread influenza easily to others," Dr. Pedro Piedra said in a statement.
Piedra was an investigator in FluMist clinical studies. He's a professor within the departments of pediatrics and molecular virology and microbiology at Baylor College of Medicine in Houston.
Yesterday's announcement came as members of the National Foundation for Infectious Diseases held a news conference announcing that the country would have 132 million flu vaccine doses this influenza season. Officials also urged those at high risk to get vaccinated against the flu, particularly children. Just one in five toddlers receives an annual flu shot, leaving thousands of children unprotected against the virus' dangerous side effects.
Each year, more than 20,000 children under age 5 are hospitalized because of the flu, and thousands more are taken to emergency rooms or clinics, according to the Centers for Disease Control and Prevention. Before yesterday, just two flu vaccines had been approved for use in children under 5, and both come in shot form. Fluzone, made by France's sanofi pasteur, is approved for children 6 months and older. Fluviron, made by California's Chiron Corp., is allowable in children as young as 4.
"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," Dr. Jesse L. Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot."
The CDC recommends children 6 months and older be vaccinated, and MedImmune, a division of London's AstraZeneca PLC, had been hoping FluMist would be approved for use in children as young as 1. But the FDA decided against it after data showed an "increased risk of hospitalization and wheezing for this age group during the clinical trials," according to a statement.
MedImmune spokeswoman Jamie Lacey said the company will continue to work toward approval for even younger children.
Efforts to gain approval for FluMist in people older than 49, another group most at risk from flu side effects, have been pushed to the sidelines while the business sought approval for young children. Lacey couldn't say whether that population was still a target for the vaccine.
The company expects to begin shipping 4.4 million doses of the new FluMist with the expanded usage label "in the coming days," Lacey said. Last year, about 3 million doses were prepared. This season's price of about $18 for doctors is similar to last year's.