Dengvaxia safety trial unfinished when vaccination program launched – Duque

MANILA, Philippines – Health Secretary Francisco Duque III said officials “could have waited” for the clinical trials on the Dengvaxia vaccine to be completed before they launched the now-suspended dengue vaccination program.

He was asked on Thursday, January 25 to clarify whether or not the clinical trials for Sanofi Pasteur’s dengue vaccine were completed before then-Department of Health (DOH) chief Janette Garin launched the program in April 2016

Duque said the Research Institute for Tropical Medicine’s (RITM) clinical trial on Dengvaxia’s safety was not finished yet when the program was implemented in public schools in the National Capital Region, Central Luzon, and Calabarzon. (READ: TIMELINE: Dengue immunization program for public school students

He said this was because the 6-year study on the vaccine’s safety lasted from 2011 to 2017. An earlier trial on Dengvaxia’s efficacy, or its ability to combat dengue, was done between 2011 to 2014.  

“They started giving the Dengvaxia as early as early 2016… The findings on the [possible development of] severe dengue came out after they concluded the phase 3 in September of 2017,” explained Duque.

“So if they had waited [for] 2017, then they would have known they can’t give these Dengvaxia [vaccine vials] to children who never had dengue in the past, because that is exactly what the advisory of Sanofi says,” added the DOH chief, who had an open forum with parents of vaccinated students in Santa Rosa Central Elementary School.

Other public health experts critical of Dengvaxia's mass use in the Philippines shared Duque's sentiments. (READ: Mass use of dengue vaccine had no backing of DOH medical experts)

Less than two years after Garin launched the immunization program, Sanofi warned Dengvaxia could lead a person to develop severe dengue symptoms if he or she had not been infected by the virus prior immunization. (READ: 'Bad science, wrong info' root of Dengvaxia problem – health experts)

Duque immediately suspended the program, but not before at least 837,000 Filipino gradeschoolers got the risky vaccine. The Dengvaxia controversy is now the subject of two congressional probes.  

The health chief has been going around schools where kids got vaccinated as part of DOH's heightened surveillance of the vaccinees.

In a statement released on January 19, RITM said Dengvaxia is safe to use and its clinical trial was accurately conducted. 

“The RITM researchers firmly stand that the clinical trial on the dengue vaccine was responsibly conducted, uncorrupted by any conflict of interests, has provided accurate and unbiased results, and most importantly, has upheld the safety of its research participants more than its scientific goals,” RITM said

The institute is mandated by law to conduct “clinical trials aimed at better understanding and control of tropical diseases,” among others. 

The RITM explained its researched may be “investigator-initiated, most often grants through competition, commissioned, or industry supported.”

Garin maintains Dengvaxia was safe and that the procurement process and implementation of the vaccination program under her term were above-board– Rappler.com 

Mara Cepeda

Mara Cepeda writes about politics and women’s rights for Rappler. She covers the House of Representatives and the Office of the Vice President. Got tips? Send her an email at mara.cepeda@rappler.com or shoot her a tweet @maracepeda.

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