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Shot in the Arm: The Swine Flu Vaccine Trial

WebMD reporter Daniel DeNoon volunteers for an H1N1 swine flu vaccine study.

Day Zero -- Thursday Aug. 13, 2009 continued...

She rolls up my sleeve and takes aim at my arm.

Is it safe? That's what they're trying to find out. The previous nurse had read me a list of the many little things and big things that could go wrong. I could get a fever or a headache, for example. I could get a skin reaction.

Or something totally unexpected could happen -- who knows what? If something serious goes wrong, I'm reassured, they'll call 911. The helpful nurse points out the window at the hospital across the street.

"And our doctors have all kinds of emergency medications on hand," she says.

How did I get here?

The Race to Test Swine Flu Vaccine

One of my jobs at WebMD is to follow the H1N1 swine flu pandemic. And here's where we stand: It's a race.

The pandemic hasn't been terribly severe. That could change. Even if it doesn't, a lot of people will get sick. And a small percentage of these people will get very sick. Some will die.

This doesn't have to happen if a safe, effective vaccine gets here first. Vaccine is rolling off the production line as I write.

Meanwhile, schools are opening -- and if we know one thing about this new flu bug, it's that it loves to infect kids. Fortunately, the weather is hot and humid. That's the kind of weather flu bugs hate. But crisp, cool weather is on the way.

Will we have an H1N1 swine flu vaccine ready in time? That depends on how long we wait. If the decision were made today, it would be four weeks -- mid-September -- before people got their first shots. And it takes two or three weeks to be protected.

If a second shot is needed, it would be mid-October before the very first people to get the vaccine would be protected.

An expert panel has already advised Health and Human Services Secretary Kathleen Sebelius to green-light vaccine distribution. But it will be hard for Sebelius or for President Barack Obama to do this without at least partial answers to some big questions: How much vaccine goes into a dose? Will it be safe? Will we need one shot or two? Will it work?

That's where the H1N1 flu vaccine study comes in. It started as fast as any clinical trial in history. I'm one of 100 volunteers who got the shots at Emory's Vaccine Treatment Evaluation Unit this week -- and there are seven other VTEUs across the country.

The nurse took a blood sample from my right arm. Before I left the clinic, it was already on the way to the National Institutes of Health for testing. That sample will be compared to others I'll be asked to give at regular intervals after I get the vaccine.

Data from these samples will be collected even as the study continues. This is very unusual for a clinical trial. But a decision on mass swine flu vaccination will have to be made before the study is over.

Every scrap of information that can be gathered will be of enormous value in deciding whether -- and when -- to offer the vaccine to the public.

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