A lawmaker on Friday demanded admission from the French pharmaceutical giant Sanofi Pasteur that it acted recklessly in prematurely selling the anti-dengue vaccine Dengvaxia to the Philippines.
Surigao del Sur Rep. Johnny Pimentel made the remark following a study confirming that Dengvaxia might be harmful to children with no prior dengue infection.
“Instead of Sanofi announcing that it now knows how Dengvaxia may be better used with the proper label warning and prior testing to ascertain if a child had been previously infected with dengue, the company should just admit that it messed up in haphazardly peddling the vaccine without enough safety trials,” Pimentel said.
“Sanofi in effect made 870,000 of our school children the subject of an unusually large clinical trial that unnecessarily put their lives and safety at risk.”
Pimentel said there were two ways Sanofi could assume responsibility for the mistake.
“They can return the entire P3.5 billion spent by the Philippine government for the three million doses of the vaccine, and they can put up an indemnity fund for the children who have been harmed, or who may be rendered sick after receiving the shots,” Pimentel said.
Pimentel heads the House committee on good government and accountability, which conducted a joint inquiry with the health panel into the Dengvaxia controversy.
The New England Journal of Medicine on June 13 published a study that confirmed that children who never had a dengue infection, but who were given Dengvaxia shots anyway, had an increased risk of hospitalization and a severe case of the debilitating mosquito-borne disease.
The study included data on 2,384 children who were vaccinated and 1,194 who were not.
Among the previously uninfected children who received the vaccine, there was a significantly higher risk of hospitalization among those aged two to eight, and a trend toward increased hospitalization in those aged nine to 16, the study found.
For previously exposed children aged nine and older, the vaccine reduced rates of severe disease and hospitalization by 80 percent versus the control group.
In April, the Department of Health disclosed that 3,281 school children were hospitalized after receiving Dengvaxia shots and that 1,967 of them “were found to have contracted dengue, as confirmed through clinical and serological tests.”
So far, the department said, 65 children had died after receiving Dengvaxia shots.
Of the 65 mortalities, 13 were due to severe dengue infection while the 52 others died of other causes.
Sanofi in January reimbursed the department P1.16 billion for the unused doses of Dengvaxia.
The House last month passed a supplemental appropriations bill that earmarked the P1.16 billion for the health surveillance and care of the children who received Dengvaxia shots under a school-based public immunization program that has since been halted.
The World Health Organization has belatedly recommended that children should first be tested to determine if they had been previously exposed to dengue infection before they could be safely considered as candidates for Dengvaxia shots.