DOH signed Dengvaxia deal while vaccine still undergoing clinical trial: PAO

David Dizon, ABS-CBN News

Posted at Feb 26 2018 11:39 AM | Updated as of Dec 12 2019 04:56 PM

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The Public Attorney's Office on Monday questioned why the health department pushed through with the P3.5 billion Dengvaxia program in 2016 even if the vaccine was still undergoing clinical trial phase 3. 

Speaking before a congressional inquiry, PAO chief Atty. Persida Acosta said Sanofi Pasteur was still conducting clinical phase 3 of Dengvaxia in November 2016 although the vaccine was already being administered to thousands of children in the Philippines. 

She noted that the results of the clinical trial phase 3 were only released in November 2017, showing that in some cases dengvaxia increased the risk of severe dengue in recipients not previously infected by the virus.

"Ang tanong - bakit naka clinical trial pa ang gamot na ito ay bakit binili?" she said. 

Acosta noted that a Sanofi Pasteur dengue vaccine report had already warned of viscerotropism, neurotropism, anaphylactic allergy and severe dengue in some dengvaxia patients. 

The Formulary Executive Council (FEC) of advisers also urged caution over the vaccine in 2016 because it said its safety and cost-effectiveness had not been established. 

The FEC said Dengvaxia should be introduced through small-scale pilot tests and phased implementation rather than across three regions in the country at the same time, and only after a detailed "baseline" study of the prevalence and strains of dengue in the targeted area, the FEC letter and minutes of the meetings said.

These recommendations, however, were ignored.

CLINICAL TRIAL 3A ALREADY DONE - GARIN

Former health secretary Janette Garin, however, said the phase 3a of the Dengvaxia clinical trial was completed in 2013. "This is the requirement not only of our [Food and Drug Administration] but international organizations in the issuance of permit," she told lawmakers. 

Former FDA chief Lulu Santiago said the results of the clinical trial phase 3a were used by regulatory authorities and technical experts in July 2015. "The statement made by Attorney Acosta with regards to the completion of the study in late 2017 was also correct pero yung sinasabi na 3a for purposes of product registration, natapos po iyung ng December 2013," she said. 

Garin has defended the procurement of Dengvaxia as dengue cases in the country, looking at the morbidity and mortality rate, reached alarming levels in 2015. She said that by 2015, the Philippines had the highest dengue outbreaks in the region with 140,000 cases.

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During the hearing, Acosta said the Department of Education and Department of Health has yet to produce the masterlist of children that received one, two or three doses of Dengvaxia. 

The PAO forensic team has already conducted autopsies on 26 of 29 children who had died after receiving one, two or 3 doses of dengvaxia. Immediate cause of death of one of the patients, Angelica Pestilos, was acute respiratory failure and the antecedent cause is pulmonary hemorrhage in all areas of the lungs, PAO said.

"Underlying cause is viscerotropic-like disease secondary to dengvaxia vaccination and the significant conditions contributing to death is Systemic lupus erythematosus, lupus nephritis and invasive pulmonary aspergillosis," Dr. Erwin Erfe testified.