EVERYONE involved in this atrocious public health scandal should be held accountable. All government officials from the Aquino administration to the current one who had a hand in the decision to immunize our children, regardless of their dengue history, with Dengvaxia should be publicly named, shamed, and prosecuted to the hilt. The same fate should befall the vaccine’s manufacturer Sanofi Pasteur.
The Food and Drug Administration licensed and approved for use Dengvaxia in December 2015. Though it was first licensed in Mexico, the Philippines became the first country to conduct an anti-dengue mass immunization program, targeting Grade 4 students, using Dengvaxia in April 2016. It was only in September 2016 that it was launched for public use in Mexico, through a private clinic launch.
According to CNN Philippines, 733,713 children have already been vaccinated.
On November 29, Sanofi Pasteur gave an update on Dengvaxia based on the results of six years of clinical data. While affirming the benefits of Dengvaxia to people with prior dengue infection, Sanofi Pasteur warned that those without prior infection are at risk of experiencing hospitalization and severe dengue if they get infected after being vaccinated.
Since the Philippines didn’t test any of the children for their dengue status prior to vaccination, this information raised alarm among the parents of the vaccinated children and medical experts.
Some say hindsight is 20/20. But there’s nothing new about Sanofi Pasteur’s advisory.
On December 1, 2015, Sen. Richard Gordon already raised the alarm about the risks posed by this vaccine to people with no prior dengue infection. In a press release, Gordon even pointed out that:
“Sanofi, manufacturer of the world’s first dengue vaccine, has admitted the drug may be harmful when administered to individuals not previously infected with dengue.
“It admitted that a new analysis of long-term clinical trial data on the said vaccine showed that Dengvaxia provides persistent protective benefits against dengue fever in those who had prior infection. However, for those not previously infected by dengue virus, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.”
And several health experts, Gordon said, informed the government about this risk. Yet despite this, the public wasn’t informed of this risk by the Department of Health (DOH). They were remiss in their duty.
Recently, I asked my readers to send me the consent form they were asked to sign to allow their children to be vaccinated. That risk, which was already known to Sanofi Pasteur and DOH, wasn’t included. The evidence I have point to the lack of informed consent from the parents.
Worse: When Karen Davila interviewed former Health Secretary Janette Garin in “Headstart” in January 2016, she asked the latter whether she could be vaccinated even if she “never had dengue.” Garin said “Yes.”
Was Garin ignorant of what Gordon knew or was she just trying to downplay that risk?
The adverse risk of the vaccine to dengue-negative individuals was also mentioned in the “Background Paper on Dengue Vaccines,” prepared by the Strategic Advisory Group of Experts (SAGE) working group on dengue vaccines and the WHO secretariat on March 17, 2016.
In the recommendation section, one of the “critical” research priorities identified was the “risk of severe/hospitalized dengue over time in vaccinated seronegatives.” Seronegatives means no prior dengue history. “Dedicated studies are needed,” the paper noted.
The paper also didn’t recommend the vaccine to “travelers” who have no prior dengue history because “vaccination may be substantially less beneficial (and there is a theoretical risk that it maybe harmful), analogous to seronegative individuals living in endemic settings.”
While the Aquino administration officials touted WHO’s “support” for the mass immunization program, they turned a blind eye to this critical issue identified in WHO’s paper on Dengvaxia. They proceeded with the mass immunization program in April 2016 without testing the students for dengue.
The Aquino administration didn’t err on the side of caution. Instead of waiting for a study to address the critical issue that WHO had identified, they took a gamble on our children’s lives. They could have just administered the vaccine to those who were tested positive for dengue, while waiting for studies establishing the vaccine’s safety to dengue-negative folks.
The red flags in WHO’s report should have lighted up Garin’s skepticism, an attitude essential to scientists. When she pushed for mass immunization for all kids regardless of their dengue history, Garin was more like a politician drunk with the prospect of glory than a scientist sobered up by skepticism.