Dec 7, 2004 (CIDRAP News) – The federal government is buying 1.2 million doses of flu vaccine made in Germany to augment the strained US supply, the Department of Health and Human Services (HHS) announced today.
HHS Secretary Tommy Thompson announced the purchase of the vaccine, made by GlaxoSmithKline, at a news teleconference. "We'll have it available this month," he said. "This will allow us to get more vaccine into the hands of those who need it most."
Because the vaccine is not licensed in the United States and licensing is a lengthy process, it will be used under "investigational new drug" (IND) rules, Thompson said. That means people will have to sign a consent form acknowledging their awareness of possible risks before getting a shot. But Thompson and Lester Crawford, acting commissioner of the Food and Drug Administration (FDA), said the vaccine is safe.
The vaccine, called Fluarix, is used in 30 countries. The FDA reviewed GlaxoSmithKline's manufacturing processes and inspected the plant that makes the vaccine before HHS decided to buy it, Thompson said.
The consent form will explain "what the public should expect in terms of risk," said Crawford. "What the public should know at this point is that the vaccine is not investigational because we have real questions about it, but because the company elected not to enter the US market last year, so they didn't apply for approval." He called the probability of safety problems with the vaccine "very low indeed."
Thompson said GlaxoSmithKline has agreed to supply up to 4 million doses to the US under IND rules, but he didn't predict how many doses HHS might buy beyond the initial 1.2 million.
The 1.2 million doses will increase the total US supply for this season to slightly more than 62 million doses, which includes about 58 million doses from Aventis Pasteur and 3 million doses of MedImmune's FluMist, Thompson said.
Thompson said the Centers for Disease Control and Prevention will distribute the GlaxoSmithKline vaccine doses where they are needed and will release a distribution plan in a few days. The company is charging HHS about $7 per dose, but there will be some additional costs for distribution, he said.
GlaxoSmithKline said the IND rules provide that the vaccine can be given to people at least 3 years old who qualify for vaccination under the current US guidelines, which reserve the shots for people in high-risk groups.
Another foreign firm viewed as a potential supplier of flu vaccine to the United States, Canada's ID Biomedical, announced today that it must save its remaining doses for Canada, according to a Canadian Press (CP) report. HHS officials had previously said they were considering buying 1.2 million doses from the Vancouver, B.C., company.
The company said it was selling the doses on the Canadian market at the request of the government, according to the CP report. The story said reports of the US vaccine shortage spurred an unusual Canadian demand for flu shots earlier this fall, sparking fears of a shortage in Canada.
At the news conference, Crawford acknowledged the ID Biomedical announcement but said the FDA was still discussing the possibility of buying some vaccine from the company. The CP report said FDA officials spent a week inspecting the firm's vaccine plant in Ste.-Foy, Que.
Crawford also said that two companies have announced this week that they want to enter the US flu vaccine market, one as early as 2005 and the other by 2007. This year Aventis Pasteur and MedImmune are the only companies providing licensed flu vaccines in the US. California-based Chiron Corp. was to have supplied up to 48 million doses before contamination problems at the company's plant in Liverpool, England, prompted British authorities to shut down the plant, triggering the American vaccine shortage.
Crawford didn't name the two companies planning to enter the market, but ID Biomedical yesterday announced a long-term agreement to sell flu vaccine to three US wholesalers, starting as early as next year, depending on licensing of the vaccine. The company said the agreement covers at least 8 years. The firm's production capacity in 2005 will be about 22 million doses, officials said.
GlaxoSmithKline, in a news release about the sale of doses to HHS, said it has "a long-term strategy" to seek FDA licensing of Fluarix.
In other comments, Crawford said the FDA has been reviewing proposals by Illinois, New Mexico, and New York City to buy a total of 750,000 doses of non-US-licensed flu vaccine made abroad by Aventis. "By the end of the week we expect to have gotten through all of the information," but he didn't predict whether the FDA will approve the plans.