Flu vaccine supply is growing and becoming more stable
■ One manufacturer receives FDA approval, and another gets closer to receiving the agency's blessing.
By Victoria Stagg Elliott — Posted Sept. 19, 2005
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The Food and Drug Administration gave the go-ahead to one manufacturer of influenza vaccine and moved another one a step closer to entering the market, according to statements issued in late August by the agency and the affected companies.
GlaxoSmithKline, which provided 4 million flu vaccine doses last season under an investigational new drug application, became the first company to receive full approval for a vaccine through the agency's accelerated approval process -- making it more likely that the company would be able to provide supply for this season.
"Having more manufacturers of influenza vaccine licensed in the United States and having more vaccine dosages is critical to public health, and I applaud the FDA for taking such a quick action," said Dept. of Health and Human Services Secretary Michael Leavitt.
The GSK vaccine is already in use in 79 countries, and the company expects to provide 8 million doses for the U.S. market.
The agency also gave signs of encouragement to Chiron Corp., which triggered last year's crisis when it was unable to supply an expected 46 million to 48 million flu shots because of contamination problems. According to a statement issued by the company, the FDA found the company's remediation work "generally acceptable." This action, in addition to a positive review issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, means the company will continue with its efforts to re-enter the U.S. flu vaccine market.
At press time, the company still needed to receive regulatory approval. But they are currently expected to produce 18 million to 26 million doses.
Combined, these two developments bring the total number of confirmed flu vaccine manufacturers up to three total and add momentum to having four producers.
Public health and medical society officials long have maintained that more manufacturers will make for more stable supplies and have worked toward that end. The American Medical Association and the Centers for Disease Control and Prevention convene a National Influenza Vaccine summit annually.
Meanwhile, Sanofi Pasteur intends to produce 60 million doses and started shipping out supplies last month. MedImmune, which makes the live attenuated intranasal version, intends to deliver 3 million doses.
In response to the fact that the total number of doses available for next season is becoming more clear though still in flux, the CDC issued recommendations this month regarding how the vaccine should be used. Until Oct. 24, the injectible vaccine should be reserved for those in priority groups. After that date, the shot is available to all. Prioritization does not apply to the intranasal vaccine.