- The Washington Times - Saturday, July 28, 2001

An advisory panel to the Food and Drug Administration yesterday found a nasal flu vaccine effective in preventing influenza, but said more safety data are needed before the vaccine — made with live flu virus — is approved.
The panel of scientists "overwhelmingly concluded there needs to be more safety data before it could recommend approval" of the experimental FluMist vaccine, developed by Aviron Inc., a California biopharmaceutical firm, said FDA spokesman Brad Stone.
Ten of the 14 panelists who voted on the safety question determined "additional safety data are needed," said Mr. Stone.
Mr. Stone made his comments in an interview that followed two days of meetings by the FDA advisers in Gaithersburg. The sessions were held for the purpose of analyzing the effectiveness of FluMist.
Earlier yesterday, the panel examined the efficacy of what would be the first nasal spray vaccine against the flu, which kills an estimated 20,000 Americans yearly. The elderly, very young children and the chronically ill are the primary victims.
FluMist, which is squirted up the nose, would be a painless alternative to the shots in the arm that are now administered to protect against the highly contagious influenza virus. While the shots are targeted to protect the most vulnerable, Aviron says FluMist is for the young and healthy, ages 1 to 64.
It is widely recognized that children would find a needle-free vaccine more acceptable. But unlike the traditional flu shots, which contain killed influenza virus, FluMist is made from live virus.
To date, the flu spray has been tested in 24,000 people. In Aviron's main study of children, either FluMist or a dummy spray, was squirted up the noses of 1,600 healthy youngsters, ages 15 months to 6 years. FluMist proved 93 percent effective in preventing the flu.
The main study of FluMist in adults showed mixed results. More than 4,500 healthy, working adults were given either FluMist or a dummy spray. The study found those who received FluMist were as likely to experience a flu-like illness during flu season as those who had not been vaccinated. However, immunized adults had a 19 percent reduction in serious illness and fewer lost workdays and doctor visits.
The FDA panel addressed the question of FluMist's efficacy in two separate votes yesterday. The panel was asked in the first vote if it finds the flu spray effective in children ages 1 to 17.
"Eight panelists said it was effective; seven said more data are needed" to determine the vaccine's effectiveness in that age group, said Mr. Stone.
Most of those who still had questions were concerned that a 1-year-old child is too young to receive FluMist. An Aviron staffer noted that five of the seven panelists seeking more efficacy data indicated they would have joined their eight colleagues who found the vaccine effective in children, had the age range been either 15 months or 24 months to 17 years.
There was far less disagreement about FluMist's efficacy in adults, despite the less-than-decisive study findings. In the second vote, the panel concluded 13-2 the vaccine is beneficial for those ages 18 and older.
Mr. Stone would not speculate on the effect the panel's findings would have on the FDA, which has final drug-approval authority.
"The panel's recommendations will be given a lot of weight, but they are not binding on the agency," he said..

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