Flumist

MedImmune Inc.'s push to market what it hopes will be its next blockbuster drug got a key endorsement yesterday when an expert panel that advises the Food and Drug Administration gave what amounts to a recommendation for its approval, though for a smaller population than the company sought. The Gaithersburg company previously had said it expected FluMist to generate as much as $1 billion in revenue within five years. But the company's estimate was based on the assumption that the vaccine would be approved for ages 1 through 64, not ages 5 through 49 as recommended by the panel.

Indiana is buying 5,000 doses of MedImmune Inc.'s FluMist nasal-spray vaccine for influenza to make up for shortages of flu shots, state health officials said yesterday. The flu season began early this year, and at least 20 illness-related deaths among children led the federal Centers for Disease Control and Prevention officials to recommend vaccinations for most people. Indiana is expecting to get another 4,450 doses of flu shots this week from the federal government. The state will pay $20 a dose for MedImmune's vaccine, or a total of $100,000, and plans to give it at no cost to healthy people ages 5 to 49, said Andrew Zirkle, a health department spokesman.

With the U.S. military considering major orders of FluMist influenza vaccine and insurers almost certain to authorize coverage of the pricey drug, MedImmune Inc. said yesterday that it will make another 1 million doses of its nasal-spray vaccine to help ease a severe flu-shot shortage. "We intend to do all we can do," said Dr. James F. Young, MedImmune's president of research and development. The Gaithersburg drugmaker also said the 1.1 million FluMist doses it has ready for distribution have been released for shipment by the Food and Drug Administration.

Caught between an increasing demand and a dwindling supply of flu vaccine, the Carroll County Health Department announced yesterday that it will administer FluMist - a recently developed nasal spray - at a yet-to-be scheduled clinic early next month. The county expects to receive 560 doses of the vaccine from Gaithersburg-based MedImmune Inc. within the next few weeks, said Larry L. Leitch, director of the county Health Department. Leitch said the Health Department will announce a time for the inoculations when the vaccine arrives.

MedImmune Inc. will assume global control of the FluMist influenza vaccine program after it and partner Wyeth yesterday ended their collaboration, the two firms said. As part of the deal, the Gaithersburg biotech also will gain the rights and clinical research data for an improved version of FluMist, a nasal-spray flu inoculation. The new version, called CAIV-T, is projected to reach the market in 2007. "As we have said, we do remain committed to FluMist," said MedImmune spokeswoman Jamie Lacey.

Yesterday's disclosure that the U.S. supplies of flu vaccines may run short could give a short-term boost to MedImmune Inc.'s so-far disappointing FluMist nasal-spray flu vaccine. But the Gaithersburg-based company and its marketing partner will have to slash the vaccine's high price if the new product is to achieve long-term success, according to an analyst who follows MedImmune. Aventis SA of France, the largest maker of flu vaccines, and Chiron Corp., of California, said yesterday that reports that a more virulent strain of the influenza virus was circulating this year had spurred more people to seek vaccinations, depleting their supply.

U.S. health officials voted yesterday to include MedImmune Inc.'s FluMist in the federal Vaccines for Children program for the flu season next year, the latest development that could boost the nasal spray's future sales. The influential and closely watched Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention in Atlanta added FluMist to the program as an alternative to conventional flu shots. As a result, children eligible for the program will be able to receive the FluMist vaccine free of charge.

For parents who wince in empathy every time their child has to be vaccinated, news that a spray can be more effective than a shot in warding off flu in very young children is promising. In the largest pediatric study comparing flu shots and flu spray, 8,000 children under age 5 were given either a shot or the nasal spray FluMist in 2004. Among the nearly 500 children who caught the flu, those who took the shots caught it twice as often. One researcher noted that although shots can enhance existing immunity, the spray is more effective in stimulating antibodies when there is no immunity.

Just days after the U.S. military was shut out in its bid to obtain a quarter-million doses of FluMist flu vaccine, MedImmune Inc. has reversed the decision of its distributor and will supply the Pentagon with the nasal spray inoculation. "We are working to supply the military, as we are working with all government agencies, in light of the current urgency," Jamie Lacey, spokeswoman for the Gaithersburg-based MedImmune, said yesterday. Lacey declined to say how many doses MedImmune would supply, but Defense Department officials said they expected to receive 50,000 doses of FluMist - far less than they had first sought, but still a major boost to tight supplies.

MedImmune Inc. is bumping up production of its FluMist vaccine for a second time, and now expects to make 3 million doses for this winter's flu season, the Department of Health and Human Services announced yesterday. MedImmune, based in Gaithersburg, originally made 1.1 million doses for this winter. When flu shot supplies were interrupted by production problems - blocking nearly half of the 100 million doses designated for the United States - MedImmune said this month that it would increase production to 2 million doses.