Sanofi, the manufacturer of Dengvaxia recently admitted that their vaccine may actually cause more harm than good. According to Sanofi, recent data from their ongoing clinical trials, have shown that those who have not had dengue before and got the vaccine are at a high risk of contracting severe dengue. In short, healthy individuals who never got dengue and took the vaccine will get sicker. This means that close to 1 million Filipino youth are at risk. This is because the Aquino administration spent Php 3.5 billion to purchase the vaccine from Sanofi at the end of the Aquino term.
Many people are asking serious questions on what happened? How could the administration spend billions of tax payer money only to cause more harm than good? Why did the Philippines spend a lot of money on a very new vaccine who has not even completed its full trial phase? How could the Aquino administration take such a risk on a drug that, at that time, did not get full WHO approval yet? There are also questions on how the contract was awarded to Sanofi, leading some people to speculate that the project was used to assist the Liberal party build a war-chest for the 2016 national election. I am not interested too much on the politics in this case right now. What I want to answer is this question: Did the Aquino administration take an unnecessary risk? This is very important because the Philippines was only the 2nd country in the world to approve the use of Dengvaxia (Mexico was first) and first in Asia.
The Sanofi stance is that the risk of severe dengue is something new that came out of their data. This seems to absolve the Aquino administration from taking unecessary risks because this side-effect was unknown at that time. Certainly we cannot fault them for taking a risk they did not know was possible. In fact the Sanofi press release at that time touted the vaccine as a miracle of science with an efficacy rate of 93{560c5a826b9d0f79d9056f2e452d35fface599afff45834a592fa1a3f7fd1a74}.
It then seems like the Aquino administration did not do anything reckless because the manufacturer has said it is safe and efficient. The problem with this is that the Aquino administration went ahead with this purchase even before the World Health Organization gave its final approval for the vaccine. Also the results of the clinical trials for Dengvaxia was available to the Philippine government at that time since it was party to the Sanofi trials. Here are some excerpts from the initial results prior to the purchase.
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The key phrase here is “While efficacy was reported against hospitalized and sever dengue in Years 1 and 2 post-dose 1, an excess of cases of hospitalized and severe dengue cases in those receiving CYD-TDV was seen in Year 3 in some subgroups, although it is based on relatively small number of cases.” It seems like the risk of severe dengue was known at least theoretically early into the trial even though the number of cases was still not that significant. The WHO report also said this: “The finding of increased risk of hospitalized and severe dengue among vaccinated participants in the younger age group in CYD14 is of concern. The mechanism for this apparent excess risk among those vaccinated is currently unexplained, although there are a number of hypotheses. While differences in the relative risk of hospitalized or severe disease among those vaccinated are associated with age, other factors such as serostatus at baseline may be as, or more, important. The potential increased risk of hospitalized or severe dengue among some vaccinees should be further investigated.” The WHO dismissed this side-effect by saying their recommendation is to start immunization at age 9 instead of younger.
There were also numerous academic studies of the vaccine trial results that came up with the same conclusion – there is a risk of severe dengue on young people who have never had dengue before. Here are excerpts from some of these academic papers:
Conversely, in the highest-transmission
settings, the main effect of vaccination on seronegative
individuals is to bring forward in time
the more severe secondary-like infection…
– Science Magazine (link)
During the course of the hospital-based surveillance, a
signal emerged from the youngest age group (2–5 years,
an age group included only in CYD14). During both the
first and second years post dose 1, the RR of hospitalized
dengue illness between vaccine and placebo arms
in the 2–5 year age group was 0.6 (not statistically
significant in either year).32 During the third year post
dose 1, there were 15 hospitalized cases in the CYD-TDV
group compared to 1 hospitalized case in the placebo
group (2:1 randomization), a RR of 7.5 (95{560c5a826b9d0f79d9056f2e452d35fface599afff45834a592fa1a3f7fd1a74} CI
1.2–313.8).35
– World Health Organization (link)
“It’s clear as the nose on my face: Vaccine recipients less than 5 years old had five to seven times more rates of hospitalizations for severe dengue virus than placebo controls…
Using Sanofi Pasteur’s data from the phase 3 clinical trials of Dengvaxia, which involved more than 35,000 children in 10 dengue-endemic countries, they showed that, during year 3 of the trial, among children ages 5 years or younger, 54.2{560c5a826b9d0f79d9056f2e452d35fface599afff45834a592fa1a3f7fd1a74} of whom were seronegative on enrollment, the dengue hospitalization rate was significantly higher among vaccinees than controls. The rate was 0.99{560c5a826b9d0f79d9056f2e452d35fface599afff45834a592fa1a3f7fd1a74} for the former (20 of 2,029) and 0.2{560c5a826b9d0f79d9056f2e452d35fface599afff45834a592fa1a3f7fd1a74} for the latter (2 of 1,005), a relative risk of 4.95, which translates into a fivefold risk of hospitalization.
According to Russell, Sanofi Pasteur has failed to directly address this phenomenon.
“What the company has done is say, ‘Well, we only vaccinate kids over the age 9,’ ” said Russell. “But age is only a surrogate here for being dengue naive. They need to directly address ADE in phase 4 studies.”
– University of Minnesota (link)
So it seems to be clear that the risk of contracting severe dengue was known early into the trials but Sanofi and the Aquino administration chose to ignore it. When the Aquino administration announced it was going ahead with making a huge commitment to the vaccine, many people sounded the alarm and urged caution but the administration at that time chose not to listen. So now that the cat is out of the bag one thing is very clear – the Aquino government was a killer and members of the past administration involved in this has to pay. The senate and the department of justice should launch a full investigation on the details of the deal brokered between Sanofi and the Aquino administration.
A government should not take such significant risk on the future of its citizens. I understand that dengue is a serious problem in the Philippines that required a serious response but it is clear, from readily available literature, that the Aquino administration took a Php 3.5 billion gamble that put at risk close to 1 million Filipino children.
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