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Variables with the vaccine include potential production problems. Production of the vaccine will be a prodigious feat: The government has already purchased 195 million doses for the coming fall and winter, which far eclipses the 125 million or so doses generally produced for seasonal flu vaccine.
Four vaccine manufacturers are wrapping up seasonal flu vaccine production and have begun production of swine flu vaccine. But another company, Sanofi Pasteur, has been more delayed and may not finish seasonal vaccine production until September, a company spokeswoman said. Sanofi is among the largest producers of flu vaccine, so those delays could have a significant ripple effect.
Packaging, distribution and other steps can take a month or more. For those reasons, the government's best guess at the moment is 40 million doses will be available in September and 120 million by around mid-October.
Health officials are pushing for the work to done quickly. There are also clinical trials taking place over the next few months to check the vaccine's safety and effectiveness, but it's possible the government will begin a public vaccination campaign before that work is complete, said Dr. Anne Schuchat, who oversees the CDC's flu vaccination programs.
Why the rush? Vaccines work when given to a patient before they're exposed to the vaccine-targeting virus, and cases may explode not long after kids get back in school, CDC officials said.
Another reason for not waiting for testing data: Health officials are thinking of the swine flu vaccine as a variation of seasonal flu vaccine, which comes out annually and does not undergo the kind of safety and effectiveness testing that new drugs and other new vaccines do.
First identified in April, swine flu has likely infected more than 1 million Americans, the CDC believes, with many of those suffering mild cases never reported. There have been 302 deaths and nearly 44,000 laboratory-identified cases, according to CDC numbers released last week.
It's not clear whether the virus in its current form is much worse than seasonal flu in terms of overall threat to the U.S. population, but it is causing more severe illness in some younger adults and children. It has a dangerous genetic characteristic that allows it to infect the lower lungs, whereas seasonal flu tends to infect the upper respiratory tract, CDC officials said.
[Associated
Press;
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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