MANILA, Philippines — Health Secretary Francisco Duque III slammed the officials of Sanofi Pasteur, manufacturer of the controversial Dengvaxia for not disclosing the possible risks of the dengue vaccine.
“They are dishonest about the risks of Dengvaxia,” Duque said at a Senate probe into the dengue immunization program, which has been suspended after Sanofi issued a warning on November 29 that post-trial tests had found risks for patients who had not had dengue before.
Duque said Sanofi had not been “forthright from the very beginning.”
“Now my index of suspicion is so high. I am pregnant with doubt,” he said.
The Health chief added: “We should not allow this. We’re talking about the lives of people here. We’re talking about the lives of our children.”
Sanofi said in its advisory that there was an increased risk of hospitalization — mostly for Grade I and Grade II dengue fever — for vaccinated patients who had not been previously infected. Sanofi made clear that the vaccine itself does not cause dengue.
The World Health Organization classifies the severity of dengue fever into four grades.
Grade I is characterized by “fever accompanied by non-specific symptoms” although patients will show hemorrhaging through a tourniquet test or through being easily bruised.
Grade II is characterized by spontaneous bleeding aside from the fever and easy bruising.
Rapid, weak pulse and narrowing of pulse pressure or hypotension with the presence of cold, clammy skin and restlessness characterize Grade III dengue, while Grade IV is characterized by profound shock with undetectable pressure or pulse.
Gordon slams Sanofi for advertising vaccine before approval
Moreover, Senate blue ribbon chair Richard Gordon slammed the French pharmaceutical giant for advertising Dengvaxia while it was being approved.
“We must not give vaccination a bad name,” Gordon said.
Former Health Secretary Janette Garin, under whose leadership the government launched the immunization program in April 2016, said that Sanofi should be held liable if the company kept information about Dengvaxia.
The France-based pharmaceutical giant, in a November 29 disclosure, revealed that the vaccine poses risks to those who were not infected by dengue virus before.
“The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection,” Sanofi said in a statement.
More than 860,000 people have been vaccinated with Dengvaxia before the immunization program was put on hold December 1.
More than 830,000 children were vaccinated with Dengvaxia in schools and communities, while another 32,000 people were immunized in private hospitals.