MANILA — Health reform advocate Dr. Anthony Leachon on Monday accused French pharmaceutical firm Sanofi Pasteur of concealing safety issues in its controversial dengue vaccine Dengvaxia.
During the House committee on good government and public accountability hearing on the Dengvaxia mess, Leachon, who was a former member of the dengue expert panel of the Department of Health (DOH), said he found it repulsive that Sanofi concealed the adverse effects of the vaccine to individuals who have not been previously infected with dengue.
“You have here a problem of concealment of data, particularly of safety,” Leachon said. “This is a great sin to the Filipino nation considering that this was a program of the government.”
Leachon said the certificate of product registration for Dengvaxia is for prescription basis only and not for mass vaccination.
“There was hasty mass vaccination based on the FEC (Formulary Executive Council). You have here a classic regulatory capture in which the companies would influence the FDA (Food and Drug Administration) and FEC,” said Leachon.
FDA director-general Nela Charade Puno, who was also present in the same hearing, said the special FDA task force found that Sanofi was given accommodation despite non-compliance with FDA standards.
Puno noted that the French drug firm kept on changing the risk management plan (RMP) which violates its post-marketing commitment.
“It is a mortal sin… When you keep changing your RMP, most of the time other countries cancel the distribution and selling of this medicine,” Puno added.
Dengvaxia, which was purchased during the Aquino administration in 2015, was later reported to pose risks to those who have not been previously infected by the virus.
The DOH has stopped the implementation of the anti-dengue vaccine drive. (Filane Mikee Cervantes/PNA)
