Dengvaxia seen to get EU accreditation

MANILA, Philippines — Despite the controversy in the Philippines, Dengvaxia has moved a step closer to becoming the first accredited vaccine against dengue in the European Union (EU).

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently recommended Dengvaxia – manufactured by French pharmaceutical giant Sanofi-Pasteur – for marketing authorization.

In an opinion, the CHMP said Dengvaxia has been proven to be effective in preventing dengue caused by virus serotypes 1, 2, 3 and 4 in people between nine and 45 years old, living in an endemic area and with prior dengue virus infection.

The CHMP declared that the benefits and safety of Dengvaxia have been evaluated in 31 clinical studies conducted mostly in dengue endemic areas in Latin America and Asia Pacific, involving around 41,000 participants with ages ranging from nine months to 60 years old.

The CHMP, however, recommended limiting the use of the vaccine to individuals with prior dengue virus infection, for whom laboratory confirmation of the previous infection is available before vaccination. 

The opinion adopted by the CHMP is an intermediary step on Dengvaxia’s path to patient access, according to the European Medicines Agency.

The opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.

“Once a marketing authorization has been granted, decisions about price and reimbursement will take place at the level of each member state, taking into account the potential role/use of this medicine in the context of the national health system of that country,” the European Medicines Agency said.

The Dengvaxia vaccine program was launched during the administration of former president Benigno Aquino III.

At least 800,000 children were administered with the vaccine but the program was suspended last year after Sanofi Pasteur warned that the vaccine might cause more severe dengue symptoms if given to individuals who have never contracted dengue. 

Former health secretary Janette Garin and other former and incumbent health officials are facing criminal charges before the Department of Justice filed by the parents and relatives of school children who allegedly died due to complications after they were given the Dengvaxia vaccine.

Also named respondents in the complaint were officials of Sanofi Pasteur and its distributor Zuellig Pharma.

The government also demanded a refund of more than P3 billion from Sanofi.