FDA panel approves FluMist for kids under 5

An expert FDA advisory panel on Wednesday unanimously voted in favor of FluMist, a nasal spray influenza vaccine manufactured by MedImmune, calling the spray safe and effective for children who are at least two years old.

The advisory panel, which was due to meet yesterday to discuss widening the approval of the drug, voted to recommend that the agency approve a request by MedImmune, to sell the drug FluMist for children under age 5. However, the panel had a decidedly mixed opinion on whether the drug was safe enough for children younger than 2.

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

The key vote was 9-6 that the vaccine was safe in children between the ages of 12 months and 59 months who didn't have a history of wheezing. This was the guideline sought by the maker of FluMist.

The panel voted 12-3 against approving FluMist for toddlers between 6 months and 23 months who had wheezing and other respiratory problems. The advisers also voted 15-0 that FluMist was unobjectionable for children ages 24 months to 59 months even if they had respiratory problems.

"The vote did demonstrate that there is a safety concern among a significant minority of the advisory committee," said Florence Houn, deputy director of the FDA office handling MedImmune's application. She added, "We do have to be careful about this respiratory adverse event profile and make sure we understand it."

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 released details of its review on Monday on its Web site, saying the nasal spray vaccine appears to prevent influenza in children as young as six months. U.S. regulators have already approved FluMist for healthy children and adults age 5 to 49.

In a separate announcement yesterday, the Gaithersburg, Maryland-based MedImmune, Inc. said that the U.S. health agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of expanding the population for use of FluMist to include children less than 5 years of age.

"We are very pleased with the committee's endorsement," said Dr. Edward Connor, executive vice president and chief medical officer at MedImmune. "We look forward to continuing discussions with the FDA in its review of our application." The FDA is scheduled to decide by May 28.

MedImmune intends to win approval for kids under 5 and as young as 1, a key market of about 16 million needle-averse customers. If the biopharmaceutical firm gets approval only for those 2 and older but younger than 5, it will lose access to several million children a year.

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.

Influenza (commonly known as "the flu") is an acute respiratory illness caused by one of the family of influenza viruses. In infants and 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.

On Wednesday, shares in MedImmune jumped 6 cents to close at $57.14.