WEDNESDAY, Aug. 31, 2005 (HealthDay News) -- The approval of a new flu vaccine was announced Wednesday by the U.S. Food and Drug Administration, brightening the outlook for the upcoming flu season.
Known as Fluarix, the vaccine is made by GlaxoSmithKline. Company spokeswoman Amanda Foley said the drug maker expects to supply about 8 million doses to the U.S. market.
This third vaccine should help ensure that this flu season goes more smoothly than the last, when one of the two major U.S. distributors of flu vaccine announced the collapse of its intended supply because of manufacturing problems at its British plant.
U.S. government officials were enthusiastic with not only the availability of the new vaccine, but also the way the approval process went.
"Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market," FDA Commissioner Lester Crawford said in a news release. "Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines."
"Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health, and I applaud FDA for taking such quick action to obtain and evaluate the data needed to license Fluarix in time for this year's influenza season," Health and Human Services Secretary Mike Leavitt said in a statement.
Those in the health-care industry are breathing a sigh of relief as well.
"It's reassuring to us that a large company is in vaccine production," said Dr. Steven Christianson, medical director of the Visiting Nurse Service of New York. "This year, we're looking at the vaccine supply being probably what's needed. Glaxo is a large company, and their putting vaccine into supply, as well as other companies, makes it much less likely that something as terrible as happened last year will happen again."
The nursing service co-sponsors free flu vaccine clinics with the New York City Department of Health.
Sanofi Pasteur, a longstanding vaccine supplier to the United States, said it has produced 60 million doses in anticipation of the upcoming flu season. "That's 2 million more than we produced last year," said company spokesman John Abrams, and about 10 million more than it produced the year before.
"Because of last year's surprise, the company decided to go ahead and manufacture extra doses," Abrams explained. The 60 million doses are completely pre-booked, he added, and the company has made sure that organizations handling high-risk individuals will be well-stocked.
The announcement came on the heels of other good news regarding the U.S. flu vaccine supply. Chiron Corp. announced Wednesday that its British facility, which was closed last year because of tainted flu vaccines, had passed U.S. regulatory inspection, putting the company on track to return the flu vaccine to the U.S. market this winter.
FDA inspectors found the company's changes "generally acceptable" at the end of their nine-day review, the company said, adding that its production of Fluvirin was already underway at the Liverpool plant and that it anticipated 18 million to 26 millions doses.
"It's premature to put a number on the actual supply for next year because manufacturing is continuing, and there are still some uncertainties with respect to Chiron, but we are very encouraged by being able to license this new vaccine, and also I think Chiron has reached a significant milestone in terms of their recent FDA inspection," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. "We're encouraged by the positive track they're on, although the assessment is ongoing. The bottom line is it's encouraging. We certainly are hopeful that there will be additional vaccine beyond what was available last year."
Last season, the government initially planned to have 100 million doses of flu vaccine available before Chiron Inc. announced problems with its manufacturing process.
The U.S. government managed to patch together a supply of about 60 million doses, some of which consisted of Fluarix, made by GlaxoSmithKline in its German plant.
Last season, Fluarix was made available under an investigational new drug application. This season, Fluarix was approved using the FDA's accelerated approval process, which allows products treating serious or life-threatening illnesses to be approved using surrogate endpoints that can be evaluated more rapidly. In other words, the company was able to demonstrate that Fluarix made levels of protective antibodies in the blood that are likely to be effective in preventing flu. GlaxoSmithKline will do further studies to verify the benefits of the vaccine.
Fluarix is the first vaccine approved using the accelerated approval process, the FDA reported. This year's supply of the vaccine is also manufactured by Glaxo's German plant.
Influenza is a serious public health problem each year. In the United States, an estimated 200,000 people are hospitalized with the flu, and about 36,000 die from the disease.
More information
The U.S. Centers for Disease Control and Prevention has more on the flu.
