The prospect that Americans receive the vaccine against swine flu in time to protect this second wave of American epidemic continues to dim. with pandemic showing "widespread activity" in 47 states-six more than a week ago, the Centers for Disease Control and Prevention now concedes that many people will be infected before they have a chance to get vaccinated. "The vaccine will come too late for many," said CDC Director Thomas Frieden told a press conference this afternoon. But he noted that the third wave of the disease can occur next winter, when that there should be enough vaccine available.
last week, Anne Schuchat, director of the CDC National Center for immunization and respiratory diseases said 28 milion to 30 million doses could be ready to the end of October, an adjustment to the significant decrease of over 40 million that Health and Human services Secretary Kathleen Sebelius predicted three weeks earlier. Although Frieden declined to new projections for the weeks and months to come, even those 28 million now seems unlikely. in the last 7 days the number has increased slightly from 11.4 to 16.1 million doses.
Frieden, who called the delays " extremely frustrating, "said manufacturers of the increasing difficulty of the virus used to make the vaccine. "Even if you yell at them, they do not grow faster," he said.
Nicole Lurie, assistant secretary for preparedness and response at HHS explained the delays Science Insider greater detail, noting that the government was something of a weather storm unforeseen problems. HHS contracted with five companies to manufacture vaccines. One, MedImmune makes a live but weakened version of the virus, which is another method for manufacturing the slain release. MedImmune has provided the product close to the scheduled time, but it does not contract for 12.8 million doses of the order of 251 million. The other four companies-CSL Biotherapies of Melbourne, Australia; Sanofi Pasteur of Lyon, France; GlaxoSmithKline London; and Novartis of Basel, Switzerland-have had different problems.
For proprietary reasons, Lurie would not name the problems of delay to each manufacturer, but said "a company was too optimistic" in its forecast of delivery to HHS. Initially, all inactivated vaccine manufacturers had problems with the "test of strength" used to ensure that 15 micrograms of influenza antigens are present in each dose. Once this has been fixed, said Lurie, the company lost 20% to 35% of antigen during the "recalibration". Unfortunately, Lurie said, the company did not notify HHS of the problem. "They thought they would compensate by getting them to return, but they know us," she said. "When we heard the problem, it was over and there was nothing we could do , which is a shame because we could have helped. "
After Columbus Day on 12 October, HHS has learned about the delays to two of the other companies. He needed a new production line for filling doses in individual syringes. "Get new production lines with prefilled syringes was very slow," Lurie said. The third company had "major problems of production" Lurie said that she could not describe in detail for proprietary reasons. Essentially, they had trouble making "acceptable" vaccine that did not contain an immunostimulant called an adjuvant, which is used in many countries but not the United States.
the final company wanted to provide his country with the vaccine before shipping products to the US, which would start the Lurie said next week. it did not identify the company but the CSL of Australia said earlier it would provide his country before exporting the product.
in response to questions about safety, Frieden said at a press conference that these companies use the same methods to make the new H1N1 vaccine they use each year to 100 million or more seasonal doses of product. But if they have so much experience making product, why so many snafus with the vaccine against the pandemic? "Almost every flu season, something goes wrong," said Lurie, noting that she was referring to manufacturing, not security.
Although Frieden explicitly refused to make predictions about future supply of pandemic vaccine, Lurie said that HHS says the state health officials later today that the Government expects to have another 10 million doses available next week. in the following weeks, projections now that manufacturers will provide 8 million to 10 million doses per week But Lurie concluded with a warning that became the mantra for the US government during this pandemic. ". It is difficult to predict a week "
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