Sanofi, DOH ignored warnings on Dengvaxia — expert

MANILA, Philippines — French pharmaceutical giant Sanofi Pasteur and health officials in 2016 ignored the warnings of experts as well as their own data on possible life-threatening risks faced by those inoculated with a controversial anti-dengue vaccine but had no previous exposure, a Senate inquiry uncovered yesterday.

The revelation came as the Senate Blue Ribbon and health committees, chaired by Senators Richard Gordon and Joseph Victor Ejercito, respectively, wrapped up their joint inquiry into the Dengvaxia controversy.

Dr. Scott Halstead, a world-renowned expert on dengue, told the inquiry that he publicly warned Sanofi in March 2016 about the dangers posed by Dengvaxia when the drug is injected to those who are “seronegative” or those who have not contracted dengue and are later infected by the disease.

He recommended to Sanofi to test first children to determine who are seronegative before inoculating them with Dengvaxia.

He said he also sent a video, through Dr. Antonio Dans of the University of the Philippines-Philippine General Hospital, to warn officials of the Department of Health (DOH) upon learning that the government planned to implement a mass vaccination program for one million school children using three million doses of Dengvaxia costing P3.5 billion.

“I was quite astonished and quite upset that this mass immunization program was going forward,” Halstead said.

He said Sanofi was aware of his concern and also publicly issued a rebuttal. He said he and Sanofi have had regular communications in the past.

However, he felt vindicated when Sanofi issued a warning in November last year on the vaccination of seronegative children using an upgraded test that he himself recommended.

He, however, said he felt Sanofi, as well as government officials concerned, had “goodwill” in pressing the development and distribution of the vaccine.

Halstead also testified that using autopsies to prove deaths caused by Dengvaxia is not conclusive.

The Public Attorney’s Office, which has been conducting autopsies on alleged Dengvaxia victims, said it has recorded at least 40 deaths of children injected with the vaccine.

The administration of former president Benigno Aquino III started the anti-dengue vaccination program in April 2016, which continued until November 2017 when the negative advisory from Sanofi came out.

A total of 837,000 children, mostly from Metro Manila, Calabarzon region and some parts of Cebu, were injected with Dengvaxia.

“It’s incredibly frustrating for a parent to year after year be worrying about the children,” Halstead said.

Dans told the inquiry there was already evidence available to Sanofi even before the company undertook a new analysis that strongly indicated the dangers of the controversial vaccine.

He said based on Sanofi’s own data, the risk of contracting severe dengue increases five-fold when serogative people are injected with Dengvaxia regardless of age.

Dans also maintained the drug company as well as the DOH leadership at the time should not have pushed through with the mass immunization since phase 3 of the testing was not yet complete.

Sanofi Asia-Pacific head Thomas Triomphe stressed the company did not only consult with Halstead but also other experts who had given positive recommendations.

He said when Halstead recommended the tests, Sanofi immediately started improving the test kit for seronegatives that led it to come up with the advisory.

“I really feel Sanofi was some kind of supercharged entity trying to ram its product down our throat,” Gordon told Triomphe.

“That is not the case but I understand how you feel,” Triomphe replied. – Mayen Jaymalin, Marvin Sy