Duque: Dengvaxia was distributed before its clinical trial ended

Health Secretary Francisco Duque III said on Thursday that the anti-dengue vaccine, Dengvaxia, was distributed before clinical trials were concluded.

Duque said at a forum for dengue prevention at Santa Rosa Central Elementary School in Laguna that Sanofi Pasteur conducted the Phase III clinical trial period on Dengvaxia for six years from June 2011 to 2017.

"They started giving the Dengvaxia as early as 2016 March. So, the findings on the severe dengue came out after they concluded Pase III sometime in September 2017," he said.

"So if they had waited 2017, they would have known they cannot give this Dengvaxia to children who never had dengue in the past. Because that is exactly what the advisory of Sanofi says, that they observed 0.2 percent of severe dengue in the over all population of 31,144 clinical trials subjects or patients," he added.

Duque added that bsed on the information, health officials could have waited until the Phase III clinical trial shall have been concluded.

"Tayo nga po ay nagtaka sapagkat nung isinasagawa ang pag-aaral, mga tatlong taon ang nakalipas," Duque said.

"Samakatwid, hindi pa natatapos yung kanilang pag-aaral at pagsusuri, ay nagkaroon na ng pasya ang dating administrasyon... na hindi pa nabubuo yung anim na taon na pag-aaral at pagsusuri, ay nagpasya na, medyo ito'y mabilis," he continued.

Dengvaxia was used in the national dengue immunization program on March 2016 immediately after it received approval from the Food and Drug Administration (FDA).

Sanofi's study covered 31,144 individuals from the Philippines, Malaysia, Indonesia, Vietnam, and Thailand, excluding those from Honduras, Costa Rica, Mexico, and two countries in South America.

Some 40,000 individuals were tested from phase one to phase three of the study in 25 clinical studies in 15 countries. Studies on the long-term efficacy of the vaccines were noted to continue until November 2017.

According to a presentation by doctors from the Research Institute for Tropical Medicine (RITM) and Philippine Society of Microbiology and Infectious Diseases in 2016, testing for the vaccine began in the Philippines in 2005.

Concern over effects of the vaccine was raised after Sanofi Pasteur admitted that Dengvaxia may increase the risk for those who received the vaccine to have severe dengue or in some cases in people who had not had the disease before immunization.

A number of findings and lapses, including Sanofi failing to collect blood samples of children prior to immunization to detect if they already had dengue, were allegedly overlooked in their rush to distribute the vaccine.

While Dengvaxia made it through the trials despite this misstep, Sanofi observed that some individuals contracted grade 1 and grade II dengue, which they defined as severe dengue.

This, however, is not the same as dengue shock syndrome, as it is defined as severe dengue in the World Health Organization's handbook.

Duque said he observed a case of an 11-year-old student in Pampanga whose symptoms were comparable to grade III dengue, beyond the symptoms observed by Sanofi.

"Sinabihan ko ang Sanofi, hindi kayo makatotoo. Kayo'y nagsisinungaling," he said.

With or without Dengvaxia, however, Duque impressed, "the threat of dengue infection is a permanent one."

Health experts in the past questioned the haste in which the dengue vaccine was distributed  to the public, its lack of subjects for its trials, and its need for a more stringent testing process.

Duque answered other concerns by parents in the forum related to Dengvaxia and advised the community to implement 4S, which stands for:

• Search and destroy mosquito breeding places;
• use Self-protection measures;
• Seek early consultation for fevers; and
• Say yes to fogging when there is an outbreak.

Parents whose children are not in the master list of students inoculated with Dengvaxia or accumulated a large bill for having their children treated were told to approach DOH local officials to receive aid in the same forum. — BAP, GMA News