KUALA LUMPUR, Feb 21 — The Philippines has permanently banned Sanofi’s dengue vaccine Dengvaxia after the treatment sparked a health scare when children allegedly died after receiving the vaccine.
The Philippines Food and Drug Administration (FDA) accused the French drugmaker of failing to submit post-approval documents. Dengvaxia has been suspended in the country since December 2017.
“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” FDA director general Nela Charade G. Puno said in a statement Tuesday.
“The FDA initially suspended Dengvaxia’s CPR (certificates of product registration) in 2017 with Sanofi directed to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA.
“The move was done following adverse events or reactions were reported by the recipients following their immunization of the Dengvaxia vaccine,” added the FDA.
Bloomberg reported that Sanofi has appealed the decision and said Philippines’ regulators were not questioning “the safety and efficacy of Dengvaxia.”
According to Philippine Star, Sanofi has refused to grant refunds for the Phillipines’ purchase of Dengvaxia or to compensate alleged victims of the vaccine.
“As we did in our previous reply to the DOH (Department of Health) on 5 February, 2018, we respectfully declined both requests [to refund the government for the used doses of Dengvaxia and finally support an indemnification fund]. We stand firmly behind our product.
“Refunding the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case. And at this time, there is no known circumstance requiring indemnification,” Sanofi was quoted saying in a statement.
Takeda Pharmaceutical Co. has reportedly made progress in a rival dengue vaccine.
The Philippines suspended its mass dengue vaccination programme in December 2017 after Sanofi acknowledged that those not previously infected by dengue fever could risk contracting a more severe infection if they received Dengvaxia.
The Philippines is now struggling with a deadly measles outbreak due to falling vaccination rates, which the country’s health secretary reportedly blamed on a scare caused by the Public Attorney’s Office that is leading an investigation into the government vaccination programme against dengue fever in 2016 and 2017.
Public Attorney’s Office chief Persida Acosta reportedly alleged that Dengvaxia led to the deaths of dozens of children, even though parallel investigations did not have the same conclusion, Al Jazeera reported.