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Tinago? Dengvaxia risks known to Sanofi in 2014, says Filipino scientist

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By: Xave Gregorio

French pharmaceutical company Sanofi Pasteur knew of the risks the controversial Dengvaxia vaccine posed to those who have not yet been infected with dengue at least three years before they disclosed that it can cause “severe disease” among those who are seronegative.

Filipino scientist Dr. Antonio Dans revealed in a Senate hearing on Tuesday (March 13) that data from the 2014 Sanofi-backed study on the dengue vaccine already suggested that it posed a high risk of disease among those who were vaccinated.

“Hindi kinailangan ‘yung new analysis dahil doon lang sa old data, mayroon na pong mga datos na nagpapakita na meroong antibody dependent enhancement (ADE) na sanhi ng bakuna,” Dans said.

ADE is an immune response where an antibody allows for increased infectivity, instead of warding it off.

Dans said the Sanofi study on Dengvaxia showed that the risk of patients inoculated with the dengue vaccine to develop severe disease were 5.5 times higher than those who were not given the vaccine.

Meanwhile, he said, the risk of developing severe dengue in patients below five years old three years after they were given Dengvaxia was 7.4 times higher and those below nine years old who were inoculated with the dengue vaccine are 8.3 times more likely to develop severe dengue three years after vaccination.

The scientist said he and other Filipino researchers attempted to raise this issue with Sanofi, but only received a strongly worded letter from the French pharmaceutical company telling them, “We are sure that you would not misrepresent data of an approved and thoroughly reviewed new vaccine.”

“We must protest against misleading public communications. And with this in mind, we are seeking correction and clarification of your comments in your Facebook page and other public fora,” Sanofi reportedly said in the letter read out by Dans to the Senate Blue Ribbon and health committees.

Leading dengue researcher Scott Halstead also came up with findings similar to Dans’, which he had told Sanofi of in 2016. But this was also reportedly ignored by the company.

The Food and Drug Administration also alleged that Sanofi knew of the risks posed by Dengvaxia as early as 2015, pointing to papers the pharmaceutical company submitted to Singapore, which said patients could develop severe dengue if they have not acquired the disease before getting vaccinated.

It was only in November 2017 when Sanofi disclosed that Dengvaxia can cause severe dengue among seronegative individuals. By then, over 830,000 children had been given the vaccine and the government has allotted P3.5 billion for its procurement.

Senator Dick Gordon, chair of the Blue Ribbon committee, said Sanofi can face charges for alleged “concealment” of the risks of the dengue vaccine.

Gordon said he is set to recommend criminal charges against Sanofi officials along with former President Noynoy Aquino, former Health Secretary Janette Garin and former Budget Secretary Butch Abad.