SANOFI Pasteur S.A., manufacturer of the controversial Dengvaxia vaccine, maintained that the protocols of the clinical trials that were conducted prior to the vaccine’s registration in 2015 received Philippine government approval.
The protocols of the trials “satisfied Philippine FDA [Food and Drug Administration] regulations, and requirements were endorsed by various national agencies and international experts, in full compliance with no less than the Guidelines of the World Health Organization,” Sanofi Pasteur Vice President Thomas Triomphe said on Wednesday.
“The Dengvaxia vaccine offers, and has clearly been shown to offer, persistent protection against dengue infection, which is undeniably beneficial to the Philippines, a country with one of the highest dengue endemicity in the world with about 150,000 to 200,000 reported cases of dengue every year—and these are just the reported cases,” Triomphe said during the hearing conducted by the House Committee on Good Government and Public Accountability and the House Committee on Health.
He added that, “as a consequence,” Dengvaxia was registered in the Philippines in December 2015.
“Since then, Dengvaxia has been registered in 19 countries in Latin America and Asia and is actually used in 11 nations [both in the private and public market].”
According to Triomphe, the vaccine “has since been able to provide sustained protection to over a million people all over the world. He maintains that, “even today, there has been no reported death…linked to the vaccine.”
He said “updated information” show that Dengvaxia has a sustained and longer protective effect on seropositive persons (that is, persons who have had been infected with the dengue virus), who constitute the overwhelming 90 percent of the population of the Philippines above 9 years of age.
Hence, with Dengvaxia, the greater majority of these people would be protected not just for a year or 3 years, but for 6 years, Triomphe added.
“To permanently remove the vaccine from the Philippine market, on the basis only of the reported 0.02-percent increased risk at the population level of getting traditionally known symptoms, would be a regression in the country’s approach to solving a major public health concern and a disservice to the Filipino people,” he said. “Doing so would, in effect, leave 90 percent of the population at the mercy of a disease that has been found to be preventable.”
Triomphe said around 150,000 to 200,000 new cases of Dengue are reported each year in the Philippines.
He maintains that dengvaxia was a result of over 20 years of rigorous research and development involving clinical trials involving more than 40,000 people in 25 studies across 15 countries.
Triomphe also apologized if his earlier statements “caused a misunderstanding.”
“I am sorry if it has created confusion, which is why I came here to say there is no need to panic.”
Earlier, Sanofi admitted that Dengvaxia is unsafe for people who never had dengue fever.
However, Triomphe, clarified that the word “severe dengue” was only used during clinical trials.
“I want to provide the facts, and I want people to understand there’s no need to panic,” he said. “I do apologize if there’s misunderstanding.”