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Swine Flu Campaign Waits on Vaccine

Officials await trial results -- testing for safety and to determine dosing -- to assess the virus's threat.
Officials await trial results -- testing for safety and to determine dosing -- to assess the virus's threat. (By Mark Humphrey -- Associated Press)
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Another wild card will be whether the vaccine will be delivered with an "adjuvant" to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.

"This is an overreaction," said Barbara Loe Fisher of the National Vaccine Information Center, which opposes many vaccine policies. "There is no national security threat here. Why are we operating like this? This is not polio. This is not smallpox."

Fears and misinformation about the vaccine are circulating, including inaccurate claims that it will be mandatory.

"I'm very concerned about the dangers of vaccines," said Janice Smith, 58, of Misawaka, Ind., who attended a public hearing Aug. 15, one of a series of meetings the CDC has sponsored to gauge public sentiment about the vaccine.

Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say.

To address concerns of pregnant women and parents with young children, some vaccine is being produced without a mercury additive. And because the short-term studies can identify only common, immediate side effects, the CDC will step up monitoring for rarer, serious complications such as Guillain-Barré.

"We're putting into place systems that are as good as we can have to identify problems quickly if they do occur," CDC Director Thomas R. Frieden said.

On Friday, officials reported that no "red flags regarding safety" had emerged in the clinical trials. "We are continuing oversight on the quality and safety of the vaccine being produced, and the production process itself," said Jesse Goodman of the FDA. "That's going well so far, but our oversight is continuing."

In the meantime, local officials are drafting plans tailored to their communities. The shots in the arms and squirts up the nose will happen in schools, medical offices, hospitals, public health clinics, workplaces, drug stores and at mass vaccination events, possibly including drive-through clinics in parking lots where people would stick their arms out their car windows for a stab.

"It is clearly what we would call an all hands on deck," said James Blumenstock of the Association of State and Territorial Health Officials. "We're not starting from scratch, but we also don't have everything on the shelf that we can just pull off and put in place. It's a full-court press in moving forward to have everything in place when we're ready to go."

In Maryland, officials estimate that 2.9 million people fall into the priority groups for the vaccine; Virginia estimates the number at 2.5 million and the District at 225,000. The national total is about 159 million people.

Public health departments "have suffered from decades of neglect and are now facing a fiscal crisis in many places where they have had to lay staff off, or furlough staff or freeze hiring," Frieden said. "So H1N1 has not come at a particularly good time."

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