By Robert B. Roque, Jr.
A lot of people want to know why the government’s P3.55-billion Dengvaxia deal with French vaccine maker Sanofi Pasteur was completed in a hurried manner.
Last Monday, the Public Attorney’s Office (PAO) revealed in a congressional inquiry that the Health department allegedly pushed through with the Dengvaxia program in 2016 even if the vaccine was still undergoing clinical trial phase 3.
PAO chief Attorney Persida Acosta stated that Sanofi was still conducting clinical phase 3 of the vaccine in November 2016 while Dengvaxia was already being administered to thousands of children.
The Formulary Executive Council (FEC) of advisers urged caution over the vaccine in 2016 because it said its safety and cost-effectiveness had not been established. It 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. It added that the vaccine should be given only after a baseline study of the prevalence and strains of dengue in the targeted area.
Unfortunately, these recommendations were all ignored.
The results of the clinical trial phase 3 released in November 2017 showed that in some cases, Dengvaxia increased the risk of severe dengue in patients not previously infected by the virus. This would explain why Sanofi admitted that the vaccine could cause more severe symptoms of dengue only last November.
However, FDA Director Nela Charade Puno said their investigation revealed that Sanofi already knew about the vaccine’s risks when its application for a Certificate of Product Registration (CPR) in Singapore in 2015 announced that it was not to be used for patients who had not contracted dengue.
Acosta said a dengue vaccine report from Sanofi warned of viscerotropism, neurotropism, anaphylactic allergy and severe dengue in some Dengvaxia recipients.
The PAO forensic team conducted autopsies on 26 of the 29 children who died after receiving Dengvaxia. In one patient, PAO found the immediate cause of death as acute respiratory failure and the antecedent cause was pulmonary hemorrhage in all areas of the lungs.
PAO forensic expert Doctor Erwin Erfe said the underlying cause was viscerotropic-like disease secondary to Dengvaxia vaccination.
Can anyone now blame the Department of Justice for forming a panel to investigate the criminal complaint against former President Noynoy Aquino, his former Health Secretary Janette Garin and former Budget Secretary Florencio Abad, along with several DOH undersecretaries and employees of Sanofi?
And is there any plausible explanation why the deal had to be rushed?
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