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Excerpt:

Rush To Produce, Sell Vaccine Put Kids In Philippines At Risk

The U.S. Food and Drug Administration just approved one of the most sought after vaccines in recent decades. It's the world's first vaccine to prevent dengue fever — a disease so painful that its nickname is "breakbone fever."

The vaccine, called Dengvaxia, is aimed at helping children in Puerto Rico and other U.S. territories where dengue is a problem.

But this vaccine has a dark — and deadly — history. One that has led to criminal charges in the Philippines, sparked national panic and fueled a massive measles outbreak that has already killed more than 355 people.

The concern

That story begins on a stage in Manila in 2016.

A young girl, about age 9 or 10, sat on a chair surrounded by health officials. She wore a bright yellow T-shirt with the words "Dengue is dangerous" across it. She squeezed her eyes and bit her lip as the health secretary of the Philippines, Dr. Janette Garin, gave her a shot in the arm.

That shot launched a massive vaccine campaign to inoculate nearly 1 million schoolchildren with Dengvaxia. The goal was to save thousands of kids' lives and prevent an estimated 10,000 hospitalizations over a five-year period.

But in the end, estimates are that more than 100,000 Philippine children received a vaccine that health officials say increased their risk of a severe and sometimes deadly condition. In addition, other children who received the vaccine may have been endangered because, their parents alleged, they were not in good health.

The French pharmaceutical company Sanofi Pasteur spent 20 years — and about $2 billion — to develop Dengvaxia. The company tested it in several large trials with more than 30,000 kids globally and published the results in the prestigious New England Journal of Medicine.

But halfway around the world from the Philippines, in a Washington, D.C., suburb, one scientist was worried about the new vaccine.

"When I read the New England Journal article, I almost fell out of my chair," says Dr. Scott Halstead, who has studied dengue for more than 50 years with the U.S. military. When Halstead looked at the vaccine's safety data in the clinical trial, he knew right away there was a problem.

For some children, the vaccine didn't seem to work. In fact, Halstead says, it appeared to be harmful. When those kids caught dengue after being vaccinated, the vaccine appeared to worsen the disease in some instances. Specifically, for children who had never been exposed to dengue, the vaccine seemed to increase the risk of a deadly complication called plasma leakage syndrome, in which blood vessels start to leak the yellow fluid of the blood.

"Then everything gets worse, and maybe it's impossible to save your life," Halstead says. "A child can go into shock."

"The trouble is that the disease occurs very rapidly, just in a matter of a few hours," he adds. "And there's nothing on the outside of the body to signify the person is leaking fluid on the inside."

The complication is rare, says Halstead. Still, he was so worried about the safety concerns that he wrote at least six editorials for scientific journals. He even made a video to warn the Philippine government about the problem.

"I just think, 'No, you can't give a vaccine to a perfectly normal, healthy person and then put them at an increased risk for the rest of their lives for plasma leakage syndrome,' " Halstead says. "You can't do that."

[More of above from source, click here]

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