FluMist appears effective for young kids- FDA

The US health agency Food and Drug Administration (FDA) says FluMist, a nasal spray influenza vaccine manufactured by MedImmune, is effective in protecting young children against this highly contagious disease, even though it may increase respiratory problems in some patients.

Federal regulators’ decision came after a review of the company's clinical testing results on the product. 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 for drug’s use in children under five years of age

However, they said it was concerned about increased respiratory problems in some patients. U.S. regulators have already approved nasal spray vaccine for healthy children and adults age 5 to 49.

An expert FDA advisory panel will be meeting Wednesday to discuss widening the approval of the drug. Although FDA is not bound to follow its advisory panel's recommendations, it generally follows their guidance. The agency makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.

The FDA released details of its review on Monday on its Web site, saying the vaccine appears to prevent influenza in children as young as six months. However, they also noted that children taking MedImmune's FluMist, a nonshot vaccine that is administered through the nose, were more likely to develop wheezing problems when compared to children treated with an injectable vaccine.

Winning approval for FluMist would mark a major victory for Gaithersburg, Maryland-based MedImmune, which was looking forward to get US health agency’s approval for younger children. The approval to market the inhalable influenza vaccine to young children could provide a major revenue boost for the company since 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.

In February, a major study conducted by researchers from medical schools in St. Louis, Tennessee, California and Finland and funded by MedImmune revealed that a nasal spray influenza vaccine that contains live virus is much more effective than traditional flu shots in protecting young children against this highly contagious disease.

The research team led by Dr. Robert Belshe at St. Louis University involved 8,475 children, 6 months to 59 months of age, at 249 sites across the United States, Europe, Asia and the Middle East to compare the effects of two major types of flu vaccine. The team found that children had 55 percent fewer cases of flu when they were protected by the nasal spray vaccine, FluMist, rather than shots.

MedImmune 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.

The company has just agreed to be bought by London-based AstraZeneca Plc for US$15.6 billion in cash. The deal is expected to close in June.

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.

Shares of MedImmune Inc. rose 2 cents to close at $57.02 on the NASDAQ Stock Market, while shares of AstraZeneca were off 15 cents at $53.12 on the New York Stock Exchange (NYSE).

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.