The furor over Sanofi’s Dengvaxia continues to roil the Philippines.
More than a year after Sanofi conceded that the dengue vaccine might raise the risk of a serious reaction for the 800,000-plus children who were vaccinated in 2016, officials in the Department of Justice say they have grounds for indicting Sanofi execs alongside former Health Secretary Janette Garin and 9 more health officials involved in the vaccination program on criminal charges of reckless imprudence resulting to homicide.
Sanofi has consistently maintained it did nothing wrong in rolling out Dengvaxia, but after touting their long running in-house program and plans to earn billions on the vaccine around the world, they have nothing but a mess to show for it — along with pending criminal indictments.
Their statement today:
We strongly disagree with the findings made against Sanofi and some of its employees and we will vigorously defend them. As this is an ongoing proceeding, it would not be appropriate for us to comment further at this time.
Even before Sanofi spotlighted the risk associated with the vaccine, independent investigators had determined on their own that the pharma giant had the data in hand to understand that the vaccine raised the risk of a severe reaction to anyone who had been vaccinated and then exposed to the virus for the first time.
In the first dengue infection, people typically get mild flu-like symptoms as their body generates antibodies that fight off the virus, which the vaccine is also designed to kick up. Three years ago, Scott Halstead and Philip Russell pointed to those antibodies as a severe threat to anyone who then is exposed to wild type dengue for the first time. At that point they assist the virus in a process called antibody-dependent enhancement, or ADE. And the most severe cases can lead to internal bleeding, a respiratory crisis, organ failure and death.
The threat Dengvaxia poses was also spotlighted in a major study published in Science just a few weeks after the Philippines got busy vaccinating people. And the researchers, including Neil Ferguson, director of the MRC Center for Outbreak Analysis and Modeling at Imperial College London, offered some widely discussed, stark warnings of ADE.
“You’d have increases in hospitalized dengue cases,” co-author Derek Cummings, a professor at the University of Florida, told CNN at the time. “It would be exactly the opposite of what you intend to do.”
Philippine Health officials and Sanofi Pasteur executives take their oaths before the Philippine Senate probe in 2017. ap images
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