CDC panel approves FluMist for two years old children

An expert CDC advisory panel on Wednesday unanimously recommended that FluMist, a nasal spray influenza vaccine manufactured by MedImmune, can be safe and effective for children who are at least two years old.

FluMist spray vaccine, which does not need to be kept frozen, only refrigerated, was initially approved by the US regulators in 2003 for use in healthy people ages 5 to 49.

And, in September, the Food and Drug Administration (FDA) approved FluMist spray vaccine, which contains a weakened form of the live virus, for healthy children between 2 and 5 years of age.

Now, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is recommending that FluMist can be offered as a flu vaccine for children as young as 2 years of age.

The committee, which advises Atlanta-based CDC on several vaccination matters, said it does not recommend the nasal spray vaccine for children with asthma, wheezing and other breathing disorders. The federal advisory panel did not endorse the needle-free FluMist over flu shots, but as an option.

A previous major study conducted by researchers from medical schools in St. Louis, Tennessee, California and Finland, found the FluMist nasal spray influenza vaccine more effective than traditional flu shots in protecting young children against this highly contagious disease.

CDC’s advisors also voted yesterday to add FluMist to a federal program that pays for vaccines for uninsured or low-income children up to age 19, urging the government to extend its FluMist coverage to the younger age group.

Although influenza vaccines often aren't covered by insurance, but the recommendations from CDC’s advisory committee can influence insurance companies' decisions on vaccination coverage.

According to CDC spokesman Curtis Allen, the agency usually adopts the recommendations of its advisory committee.

Developed by Gaithersburg, Maryland-based MedImmune, FluMist is administered through the nose, and is the only influenza vaccine on the market that can be inhaled and not a shot.

"The flu virus comes at you through the nose. And so we're providing protection at the point of attack, if you will, by giving the vaccine in the nose and inducing an immune response right there where the virus, the flu virus, is going to come in," said Frank Malinoski of MedImmune.

MedImmune, acquired by London-based AstraZeneca Plc in June 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 its nasal spray flu vaccine FluMist, 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.

In 2006, FluMist sales totaled more than $36.4 million, lagging behind MedImmune's own 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.

Influenza, generally 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, flu can lead to pneumonia, hospitalization, and even death. Each winter, influenza engulfs 36,000 lives in America, most of them elderly and children, and more than 200,000 people are hospitalized with flu-related complications.