Ombudsman orders DOH to submit Dengvaxia's clinical trial papers

MANILA, Philippines – The Office of the Ombudsman has ordered the Department of Health (DOH) to submit documents involving the clinical trials done on the controversial Dengvaxia dengue vaccine.

This is in response to two complaints filed late last year against government officials who implemented the now-suspended dengue vaccination program, as well as against private individuals working for Dengvaxia maker Sanofi Pasteur.

Ang mga dokumentong hinihingi ng Ombudsman ay lahat patungkol sa clinical trial na isinagawa dito sa Pilipinas ng RITM (Research Institute for Tropical Medicine) being the lead investigator. The RITM provided the science behind the Dengvaxia immunization,” said Duque in a press conference on Thursday, January 25.

(The documents being requested by the Ombudsman all concern the clinical trials done in the Philippines by the RITM, which was the lead investigator. The RITM provided the science behind the Dengvaxia immunization.)

The DOH chief previously said his department is willing to provide all the necessary documents to government agencies and groups probing the Dengvaxia controversy. 

Gabriela party list had filed a graft complaint against former president Benigno Aquino III, former health chief Janette Garin, former Budget Secretary Florencio Abad, and former Executive Secretary Paquito Ochoa Jr over the immunization program implemented during the term. Sanofi officials were also implicated in the complaint. 

Gabriela also filed a petition requesting the Supreme Court to require the DOH to adopt a policy of free medical services for children who received the Dengvaxia vaccine. 

Augusto “Boboy” Syjuco Jr’s complaint, meanwhile, accuses the officials from the previous administration of “mass murder” for allowing the mass use of Dengvaxia.

Public health experts had sounded the alarm when Garin launched the dengue vaccination program in public schools in the National Capital Region, Central Luzon, and Calabarzon in April 2016. (READ: TIMELINE: Dengue immunization program for public school students

They argued clinical trials on the safety, efficacy, and cost-effectiveness of Dengvaxia have not been completed at the time. Duque confirmed this on Thursday. 

The RITM conducted the efficacy trial for Dengvaxia in 2011 to 2014 and its safety trial in 2011 to 2017. The efficacy trial was conducted in the Philippines along with Malaysia, Thailand, Vietnam, and Indonesia, while the safety trial was conducted in Brazil, Colombia, Honduras, Mexico, and Puerto Rico.

Of the 31,144 clinical trial participants, 3,501 were Filipinos.  

On November 29, 2017, Sanofi released an advisory saying Dengvaxia can cause a person to develop severe dengue if he or she had not been infected by the virus prior immunization.

About 837,000 Filipino children got the risky vaccine through their schools before Duque suspended the program on December 1, 2017.

The Dengvaxia controversy is now the subject of separate investigations by the Senate and the House of Representatives. Aquino, in a Senate hearing, said he was made to understand Dengvaxia was safe and no had advised him against its use.

On Thursday, Duque conducted an open forum with parents of vaccinated students at Santa Rosa Central Elementary School. It is part of the DOH’s initiative to closely monitor the health status of the children who received Dengvaxia. – 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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