FORMER health secretary Enrique Ona on Monday blamed his successor, Janette Garin, for the “health nightmare” the country was facing because of the risks posed by the anti-dengue vaccine Dengvaxia.
At the resumption of the Senate Blue Ribbon inquiry into the P3.5-billion Dengvaxia vaccine deal, Ona said the Department of Health (DoH) during his time did not allocate funding for an anti-dengue vaccine in 2015 because it was still in the development stage.
In fact, he said, a 2015 article published by the New England Journal of Medicine concluded that the vaccine’s “efficacy profile at 25 months surveillance was complex.”
“Any expert in public heath would have waited for more studies to further evaluate the safety and efficacy sans cost,” he told the committee.
The former health secretary also noted that during his four-year stint at the department, Sanofi Pasteur, the producer of the dengue vaccine, would brief him on a yearly basis on the status of the clinical trial being conducted by the pharmaceutical firm in Southeast Asia, including the Philippines, and countries in South America.
He admitted that the anti-dengue vaccine was of great interest to him because dengue was rampant in the Philippines at the time, infecting more than 100,000 individuals annually.
However, Ona said, Sanofi, during the trial process and until he left the department, never claimed that the vaccine was ready for general use and only gave vague projections in relation to the clinical trials.
“In light of this Sanofi Pasteur advisory on the use of anti-dengue vaccine Dengvaxia, the leadership that took over the DoH after I left in December 20, 2014 are solely responsible for all the decisions that has resulted in what is becoming to be a major health nightmare in the country,” Ona said.
Sanofi Pasteur has reportedly decided to return to DoH P1.16 billion representing the price of the stocks of unused Dengvaxia.
The DoH during the administration of President Benigno Aquino 3rd inoculated about 850,000 school children in Metro Manila, Central Luzon, and Calabarzon (Cavite, Laguna, Batangas, and Quezon) under the school-based anti-dengue vaccination program.
Sanofi in November 2017 issued a statement admitting that Dengvaxia could increase the risk of hospitalization for dengue and severe dengue on individuals not previously infected by the disease.
The national expert panel formed by the DoH told the inquiry the anti-dengue mass immunization program should remain suspended because of lack of information about the possible effects it would have on individuals inoculated with Dengvaxia.
“In view of the sparse information from the clinical trials on the consequences of administration of less than three doses of Dengvaxia, a firm recommendation to complete the schedule of vaccination cannot be given,” the panel stated in its summary report submitted to the Blue Ribbon committee.
The launching of the program was done before the Research Institute for Tropical Medicine (RITM) completed Phase 3 of the clinical trial of Dengvaxia that started in June 2011.
According to RITM Medical Specialist 4 Ma. Rosario Capeding, Phase 3 involved at least 31,144 children from Southeast Asia and South America, including 3,501 children in the Philippines aged two to 14 years old.
She explained that Phase 3 has two stages, namely vaccine efficacy and the surveillance stage that need to be done before the clinical testing could be considered complete.
Capeding said that under the vaccine efficacy phase, children enrolled in the test were given three doses at six-month intervals.
After completing the doses, the children would undergo the surveillance phase wherein they would be observed for a year.
RITM supposedly finished Phase 3 in October 2017, more than a year after the DoH started the anti-dengue vaccination program.