WASHINGTON — Federal health officials said Thursday that they might buy 5 million flu shots from Germany and Canada to combat a severe shortage in the U.S. -- a strategy that ultimately could end the nation's reliance on just two suppliers of the scarce vaccine.
Teams from the Food and Drug Administration next week will inspect supplies at a GlaxoSmithKline plant in Germany, which may have 4 million available doses, and at ID Biomedical Corp. in Canada, which may have 1.2 million, said Tommy G. Thompson, secretary of the Department of Health and Human Services.
If approved, the extra vaccine will enter the U.S. under a special "investigational" new-drug application. People who get shots will have to sign a consent form disclosing that the medication isn't licensed in this country.
The FDA inspectors will need to "confirm the availability of the vaccine, assure the American people ... that the vaccine can be used safely, [then] we will make arrangements to acquire them," Thompson said.
If all goes well, he added, the vaccine probably will be available in the first half of December. Although people often seek shots before then, flu season can peak as late as February and March.
The additional doses would replace only about 10% of the vaccine shortfall, but some saw broad significance in the government's decision to invite ID Biomedical and GlaxoSmithKline into the U.S. marketplace.
"It certainly means that the U.S. government views both companies as viable suppliers," said drug industry consultant David Webster. He said the action opened the door for firms to enter the U.S. as soon as next year -- if Chiron Corp. remained unable to provide vaccine.
The Emeryville, Calif., company was unable to ship its inventory of up to 48 million doses this year when British health authorities shuttered its factory in Liverpool on Oct. 5 after discovering bacterial contamination.
ID Biomedical and GlaxoSmithKline "are going to watch very carefully what happens with Chiron over the next 60 days, and if they feel there is a high likelihood that Chiron will not be there next year, I would expect them to enter," Webster said. He added that the U.S. market could support three to four flu vaccine makers.
U.S. health officials had counted on 100 million vaccine doses for the emerging flu season, but Chiron's sudden exit cut the available amount almost in half. Since then, the government has arranged for extra doses from Aventis Pasteur, the other major flu shot supplier to the U.S., and MedImmune Inc., which makes a nasal-spray vaccine. Officials now say they have access to 61 million vaccine doses over the next few months.
The prospect of two new suppliers, even with a limited, provisional status, suggests that the shortage may be sparking a change in the marketplace.
The number of U.S. flu suppliers has steadily dwindled in recent years, with companies blaming regulation and fluctuating demand for the shots. But the current shortfall has prompted a rethinking. For example, Thompson has floated a proposal that the government should guarantee significant purchases to bring stability to the marketplace.
Moreover, prices that manufacturers receive for their shots have risen in recent years, and the market has grown from 20 million doses in the early 1990s to 80 million last year.
As vaccine economics improve, companies brought in now "might like to enter the U.S. market on a permanent basis," said William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt Medical Center and an advisor to the Centers for Disease Control and Prevention on the flu vaccine.
In fact, ID Biomedical and Glaxo planned to enter the U.S. market before the crisis began. In September, ID Biomedical announced a $45-million expansion of its Montreal vaccine factory, with hopes of selling flu shots in the U.S. by 2007.
Glaxo hasn't announced a specific time frame.
ID Biomedical has offered to provide the U.S. 10 million to 12 million doses next year. Company spokeswoman Michele Roy said negotiations had not started over supplying vaccine in 2005 because arranging to provide doses for this flu season was a priority.