FDA approves FluMist influenza vaccine for young kids

The US Food and Drug Administration (FDA) has approved on Wednesday a nasal spray influenza vaccine FluMist for the treatment of children between 2 and 5 years of age, saying it can be effective in protecting young children against this highly contagious disease.

Manufactured by MedImmune, FluMist spray vaccine that contains a weakened form of the live virus was previously approved for healthy children and adults age 5 to 49.

The approval by federal health agency came seven months after a major study conducted by researchers from medical schools in St. Louis, Tennessee, California and Finland, found the FluMist influenza vaccine effective in young children.

In February, the study which involved 8,475 children, 6 months to 59 months of age, at 249 sites across the United States, Europe, Asia and the Middle East discovered that children from 6 months to 5 years old had 55 percent fewer cases of flu when they were protected by the nasal spray vaccine FluMist, rather than traditional shots.

FluMist spray vaccine, which does not need to be kept frozen, only refrigerated, was not yet licensed by the FDA for children under 5, but after examining the trial results the agency gave its node to FluMist for children 2 to 5 years old.

"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "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."

However, FDA is not allowing use of FluMist for children under 2 due to an increased risk of hospitalization and wheezing being reported in clinical trials.

The U.S. Centers for Disease Control recommends flu vaccination for those aged 6 months to 5 years to prevent the spread of the virus. Before the approval of FluMist, there were only two vaccines licensed in the U.S. for children under the age of 5, Fluzone, manufactured by Sanofi Pasteur and indicated for children over 6 months of age, and Fluvirin, available for use in children age 4 and older, manufactured by Novartis.

Winning approval for FluMist marks a major victory for Gaithersburg, Maryland-based MedImmune, which was looking forward to get federal regulators’ approval for younger children.

"As a company dedicated to innovative advancements in pediatric medicine, MedImmune is delighted to be able to offer FluMist as an option for children as young as two years old to help protect them from influenza," said James F. Young, Ph.D., President, Research and Development. "With the new, refrigerated formulation approved in January, the results from our head-to- head study published in the February issue of The New England Journal of Medicine, and the expanded age indication now within the label, it is an exciting time for FluMist."

The approval to market the inhalable influenza vaccine to young children could provide a major revenue boost for the company. In 2006, FluMist sales totaled more than $36.4 million, lagging behind MedImmune's top-selling respiratory virus drug Synagis, which posted sales of $1.1 billion. FluMist competes with injectable flu vaccines made by GlaxoSmithKline Plc, Sanofi-Aventis' Sanofi Pasteur unit, and Chiron, which was recently acquired by Novartis AG.

MedImmune, which recently has bought by London-based AstraZeneca Plc for US$15.6 billion in cash, is a biopharmaceutical company that develops and markets products to combat infectious disease and cancer, among other things.

Its flagship product, Synagis, prevents respiratory syncytial virus (RSV), a major cause of pneumonia and other respiratory disease in infants and children. Besides FluMist, its nasal spray flu vaccine, also on the market are Ethyol, which treats side effects of chemotherapy and radiation; and Neutrexin, a treatment for a kind of pneumonia that often afflicts AIDS patients.

Influenza (commonly known as "the flu") is an acute respiratory illness caused by one of the family of influenza viruses. In infants, persons over the age of 65 years, and those with chronic medical conditions, the flu can lead to pneumonia, hospitalization, and even death. Each winter, influenza engulfs 36,000 lives in America, most of them elderly and children.