Fast-tracked dengue vaccine wreaks havoc in the Philippines, 600 child deaths under investigation — Health & Wellness — Sott.net
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.”
The vaccine manufacturer disagreed with Halstead’s interpretation of the study’s results. The company wrote a rebuttal, asserting that regulatory agencies had approved Dengvaxia “on the basis of the vaccine’s proven protection and acceptable safety profile.”
The company also said it would perform additional studies to “further access the safety, efficacy and effectiveness” of the vaccine.
Despite these concerns, in July 2016, the World Health Organization went ahead and recommended the vaccine for all children ages 9 to 16.
“Yes, we did. It was what we call a ‘conditional recommendation’ with the emphasis to minimize potential risks,” says Dr. Joachim Hombach, who led WHO’s review of the vaccine. “We saw the problems. We also clearly pointed to the data gaps.”
WHO recommended that Sanofi do more experiments to better understand the vaccine’s safety issues. In its assessment, WHO pointed out that the vaccine “may be ineffective or may theoretically even increase the future risk of [being] hospitalized or severe dengue illness” in people who have never been exposed to dengue – which is about 10% to 20% of Philippine children.
WHO’s recommendation came three months after the Philippines launched its mass vaccination campaign in April 2016.
A year and half later, that campaign came to a screeching halt.