At the University of Connecticut, planning for the H1N1 virus means, to begin with, clearing some serious storage space:
STORRS, Connecticut (CNN) — At the University of Connecticut, planning for the H1N1 virus means, to begin with, clearing some serious storage space: • 15,000 surgical masks for patients who might become infected. • 28,000 doses of Advil • 28,000 doses of Tylenol • 10,000 fever thermometers • Thousands of bottles of hand sanitizers. “We have been busy working all summer,” said Mike Kurland, director of student health services at the university. “We are making the necessary preparations and hoping for the best.” So far, about two weeks into classes, the University of Connecticut considers itself fairly lucky: one confirmed case of H1N1 and two probable cases. “The amount that we will see is the unknown,” Kurland said in interview at the campus infirmary. “But we do anticipate an outbreak of H1N1 virus or influenza-like illness.” Prevention and education are priorities. In dorms and classrooms, and at early semester gatherings, there are quick pointers to students, faculty and campus workers on “respiratory etiquette” when coughing or sneezing and reminders to wash hands frequently, use the sanitizer gel that is seemingly everywhere — and to stay home if feeling ill.
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“We’ve really scaled it up to a much larger, comprehensive program,” Kurland said. So far, Kurland gives high marks to both state and federal officials for their efforts. In August, the Connecticut Department of Public Health and Yale University co-sponsored a conference to help schools prepare, and as CNN visited the campus this week, Kurland has wrapped up his latest conference call with federal officials, this one a mix of experts from the Department of Education and Centers for Disease Control and Prevention. The University of Connecticut has about 20,000 students at Storrs; nearly 12,000 of those live on campus. Plus, more than 4,000 people work on campus. The seasonal flu shot is available to students, and the university has requested 20,000 doses of H1N1 vaccine from state health officials. You won’t find those in the H1N1 stockpiles though; the vaccine is still in production. “All we know is distribution will begin in October at some point,” Kurland said. “Not all doses will be available at once. There will be a small amount initially, and then each week more will come through. … It’s very frustrating. … We know we might have to vaccinate 20,000 people, don’t know when and we’re just remaining flexible and it will work out.” The vaccine isn’t available anywhere in the United States yet.
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The Department of Health and Human Services has said limited doses should be available in the first week of October, with the bulk of the vaccine starting to arrive October 15. But in a nondescript industrial building in the central Connecticut town of Meriden, we reached into a refrigerator Wednesday and held a small vial its producers say is a safe H1N1 vaccine that can be produced much faster than the vaccines the government has ordered. Perhaps, but it could be months or more before the company, Protein Sciences Corp., knows if the federal government shares that view. Daniel Adams, the company’s president and CEO, said the preliminary date from clinical trials in Australia “looks extremely good.” The company is first waiting for Food and Drug Administration approval of its seasonal flu vaccine, which Adams predicted would come by the end of the year, or early in 2010. After that, Protein Sciences would have to request approval for its H1N1 vaccine, a process that could carry on well into 2010 and even beyond. The FDA does have emergency powers to put a drug or vaccine on the market soon, and Adams said that was a distant possibility if something went awry in the federal supply line for the H1N1 vaccine. Those orders are for vaccines made through traditional means: made from eggs that are injected with the flu virus. Protein Sciences uses recombinant DNA technology to produce its vaccines using a single protein from the virus. The protein is produced in caterpillar cells. “And that purified protein is our vaccine,” said Clifton McPherson, the Protein Sciences quality control director. “So we never have to handle live flu virus.” In the Protein Sciences quality control labs this week, the focus is on testing the company’s traditional, seasonal flu shot — FluBlok — and making sure all the documents are in line should the FDA and other agencies have any questions. In a separate building across the road, a sanitary production facility — access is controlled with a series of electronic locks and airlocks — is gearing up to produce the company’s H1N1 vaccine, PanBlok. “We could make roughly 54 million doses next year … maybe more,” Adams said. The company recently won a $147 million, five-year contract and is converting a former electronics manufacturing plant into a bigger vaccine production line. During the interview, Adams received a call from South Korea. He said that the company also is negotiating with China and Mexico and that it has growing relationships in Japan and Australia. “Each one of those countries is free to approve our vaccine based on their own standards and approval by their regulatory authorities,” Adams said. “And we think they need our vaccine to protect their people.” In the United States, at least in the short term, “we definitely are ‘Plan B’ because we will need the emergency use authorization in order to sell our vaccine,” Adams said. But with the U.S. taking so much of the initial production of H1N1 vaccines produced by traditional means, Adams said he believes there is a significant international demand and his company will be among the suppliers trying to satisfy it.
He said he would, from a competitive business standpoint, prefer the FDA move more quickly in assessing his and other new drug products. But overall, he said he gives the government high marks. “You really don’t want to do any harm — that is your first rule — so they are looking at safety,” Adams said. “I think they are doing a pretty good balance to be honest. I know people are frustrated by the speed. Some people say it is too slow. Some people say it is too fast. Seems to be about evenly spread out. So I think they are about in the right place.”