THE controversial vaccine Dengvaxia, manufactured by French pharmaceutical giant Sanofi Pasteur, could not be used to deal with the dengue outbreak, Health Assistant Secretary Abdullah Dumama Jr. said Thursday.
He told reporters the vaccine could not be administered to patients while they are suffering from the dengue fever and could have “a heightened risk of contracting severe dengue” when given to individuals who were not previously infected with the mosquito-borne disease.
DOH officials will meet this month to discuss whether it will reconsider the motion for reevaluation filed by the vaccine manufacturer, he said.
“During the outbreak, you cannot introduce the vaccine to patients while they are suffering from dengue. Dengvaxia is effective, according to their claim, if you suffered from it already,” Dumama said.
If the request for re-evaluation is approved, Dumama said that the Food and Drugs Administration would be the one to undertake it.
He said the result might take time because re-evaluation will not be done in haste.
“The Sanofi should be certified as a manufacturer with Certification of Product Registration (CPR) from the FDA,” Dumama said.
The health official added that the vaccine would undergo a series of researches by experts before the re-issuance of the CPR, which was revoked in 2017, at the height of the Dengvaxia scare.
The DOH declared a National Dengue Epidemic Aug. 6, in the wake of the increasing reported cases of dengue in the country. The agency recorded 146,062 dengue cases from January 1 to July nationwide with 622 deaths.
A briefer from DOH-11 said the department received a preliminary briefing on updated information on the dengue vaccine from the manufacturer, Sanofi Pasteur, on Nov. 29, 2017.
It said the vaccine has “shown consistent and sustained benefit for those who were previously infected with the dengue virus” and can give the patient immunity from severe illness for at least 30 months.
“In the longer term, severe cases may occur following a subsequent dengue infection among those who were not previously infected,” it said.
It added that the DOH has already put on hold the dengue vaccination program while review is being undertaken by experts, key stakeholders and the World Health Organization (WHO).
It said dengue fever and dengue hemorrhagic fever are acute viral infections that affect infants, young children and adults.
According to WHO, the Dengvaxia was the first dengue vaccine, which was first registered in Mexico in December 2015.
It added that the vaccine “is a live recombinant tetravalent dengue vaccine that has been evaluated as a 3-dose series on a 0/6/12 month schedule in Phase III clinical studies. It has been registered for use in individuals 9-45 years of age living in endemic areas.” (Antonio Colina IV, Mindanews)