Illinois officials said Tuesday they could get at least 262,000 doses of flu vaccine through a British wholesaler and are looking for more, but the federal approval process to import the vaccine could take weeks and federal officials haven't even agreed to start the process.
The flu vaccine Illinois officials want to buy is made by Aventis Pasteur, one of the two major U.S. flu vaccine suppliers, but it is manufactured at a different plant in France that supplies Canadian and European customers.
Federal officials say that vaccine would have to pass U.S. Food and Drug Administration requirements to be approved for distribution in the United States, a process that could take weeks if not months.
That could make the timing tight for Illinois; the federal Centers for Disease Control and Prevention recommends people be vaccinated for flu in October or November.
Gov. Rod Blagojevich sent a letter to the FDA Monday asking permission to distribute at least 62,000 doses of the vaccine to Illinois nursing homes and hospitalized children. On Tuesday, he said state officials had found 200,000 additional doses through the same British wholesaler, Ecosse.
Acting FDA commissioner Lester Crawford has said his agency would evaluate Blagojevich's request, but he did not say how soon it would respond. Calls to the FDA Tuesday were not immediately returned.
Blagojevich spokeswoman Abby Ottenhoff said the governor hoped to schedule a meeting with FDA officials by the end of the week.
The U.S. flu vaccine shortage was discovered Oct. 5 when regulators closed Chiron Corp.'s labs in Liverpool, England, cutting the expected U.S. supply by 48 million doses, almost half.
The flu vaccine Blagojevich wants to bring in has not been clinically tested on U.S. flu patients, but the governor said a review of the literature showed its properties are identical to those of the vaccine used in the United States.
Federal officials, however, warn that the vaccine still might not be effective because it may be made differently than the U.S. flu shot and, since it would be purchased through a wholesaler rather than directly from the manufacturer, there could be other problems. Vaccines must be stored properly to ensure their effectiveness, for example, said Dr. Bruce Gellin, head of the government's National Vaccine Program.
The FDA and U.S. Department of Health and Human Services say they are working with pharmaceutical companies in other countries to find more flu vaccine for U.S. use.
Crawford said last week that the FDA would give an expedited review to a flu vaccine produced by ID Biomedical of Canada. The expedited review would still take weeks, but the 1.5 million Canadian flu shots could reach Americans this season, he said.
Federal officials contend the vaccine shortage is not a public health crisis.
U.S. Department of Health and Human Services spokesman Bill Pierce said there are 61 million doses of the vaccine and up to 40 million people could receive antiviral medicine, which shortens illness in people sick with the flu and prevents illness in healthy people.
Illinois officials do not know how many residents are in need of the flu vaccine, but state health department officials conducted a survey this month that estimated the vaccine shortage at about 150,000.
If Illinois gets approval to import the vaccine from Ecosse and ends up with leftovers once the state's at-risk residents have had access, the extra doses could be offered to other states, Blagojevich said.
The governor has been at odds with the FDA over federal regulations barring the import of prescription drugs from Europe and Canada, where government price controls often mean the drugs are less expensive. The FDA argues it can't ensure the safety of imported drugs, and it recently sent a letter of complaint about Blagojevich's I-SaveRx program, which connects state residents with pharmacies in Europe and Canada.
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