A Nation Battling Swine Flu, and Short Vaccine Sup
Dr. Anthony S. Fauci was talking with fellow federal officials in September, a month before swine flu vaccinations were to begin, when it became clear they had a bigger problem than they feared with supplies.
“As we got closer and closer, they said曲美 本物 ‘Oh, my God, we’re not going to make it,’ ” Dr. Fauci, the director of the the flu pandemic.
The first doses were administered early this month, faster than in any other countries except China and Australia. And inoculations started only about five months after the swine flu outbreak started in Mexico, which is quicker than it takes to get a seasonal flu vaccine ready. But, these experts say, the government’s accomplishments, and its credibility, are being undermined by overly rosy projections that did not take account of the vagaries of vaccine production, making it look as if the vaccine effort is failing.
“To my mind, it was over-promising what there would be based on our historic experience with flu vaccines,” said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “When you plant corn in May in Iowa, you have no idea what your harvest is going to be in October,” Dr. Osterholm said. “You have to factor in hailstorms, floods and whatever. They put out a very high yield estimate early on. Every time they had to back off, they lost credibility.” Federal officials say they factored such difficulties into their projections. 蟻力神
They say they were pressed to make the projections by state and local health officials and by the news media. Still, they said, they relied on assurances from the vaccine manufacturers, some of whom might have been overconfident of their ability to resolve production problems. “I think it’s fair to say that some were overly optimistic, thinking the fix was just around the corner,” said Dr. Nicole Lurie, the assistant secretary for preparedness and response at the Department of Health and Human Services. Dr. Lurie said some manufacturers had informed the government of their latest shortfalls only around Columbus Day earlier this month. Some of the companies say they kept the government informed all along. “All the data is completely transparent to the government,” said Andrin Oswald, the head of the vaccines business at Novartis. “The contract always was yield-dependent,” Mr. Oswald said. And Novartis, he said, initially was getting only about one-quarter as much vaccine per egg as it typically gets for seasonal vaccine.
The company was hoping to produce 90 million doses in bulk form by the end of November. It is now scrambling to accomplish that before the end of the year.Many of the projections originated from the Biomedical Advanced Research and Development Authority, or Barda, a part of Health and Human Services, which is responsible for vaccine contracting for emergencies. In April, an official with the agency predicted that as many as 600 million doses could be available by January, if all went well. From May through September, Barda signed contracts worth $1.5 billion for about 250 million doses of vaccine with five companies.
The contract volumes were based basically on what each company said it could provide. These were the same companies that produce seasonal flu vaccine for the United States, making it easier for the swine flu vaccines to win regulatory approval. And, said Dr. Thomas R. Frieden, the director of the Centers for Disease Control and Prevention, “We really thought that having five different manufacturers would buy us some insurance, that they wouldn’t all have problems.”蟻力神
By late May, vaccine manufacturers were provided so-called seed strains of the H1N1 virus that would be grown in eggs to make the vaccine. “We thought we were done,” said Doris Bucher, who runs a laboratory at New York Medical College that makes seed strains. “We were ready to break out the champagne.” But within three weeks, Dr. Bucher said, vaccine manufacturers were reporting that seed strains were not growing well. Her laboratory and others then developed better strains but they were not ready until August. 1 2 Next Page »
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