Now comes the dengue vaccine breakthrough
Dengue. Mere mention of this dreaded disease is enough to make us cringe or shudder in fear. And so, imagine our excitement reaching fever pitch as Sanofi Pasteur officials Dr. Alain Bouckenooghe, associate VP and regional head of clinical R&D Sanofi Pasteur, Asia Pacific hub, and Joshua Nealon, head, epidemiology, Asia & JPAC Region, Sanofi Pasteur Singapore, meet local media to talk about the world’s first dengue vaccine Dengvaxia, which was awarded the Vaccine Breakthrough of 2016 at the 6th Biopharma Industry Awards.
Dengue History In The Philippines
But first, the facts and figures (everything you’ve always wanted to know about dengue but didn’t know who to ask). The first known dengue epidemic (or dengue hemorrhagic fever) anywhere in the world was recorded in Manila back in 1953. By 2004 until 2010, the country harbored the seventh highest number of dengue cases in the world, according to the World Health Organization. In 2013, the Department of Health reported 204,906 dengue cases, the highest number recorded since the National Dengue Prevention and Control Program was put up in 1993. Although there was a slight decrease in reported cases in 2014, data in 2015 and 2016 show an alarming increasing trend. In 2015, dengue cases reached epidemic proportions with an average of 220 cases reported every day.
“Dengue has four serotypes; in the Philippines, all four are constantly circulating, it’s a hyper-endemic country,” Sanofi Pasteur’s Joshua Nealon tells us as he points at a graph during his PowerPoint presentation. “In the top right, you can see the distribution of the disease, so most cases here happen between the ages of five and approximately 20 years old, and the median age of infection is 12 or 13 years of age.”
Posing a year-round threat to the Philippines, dengue data suggest that the number of cases increases one to two months after the onset of the rainy season, thus peaking between July and November each year. Vulnerable to the effects of climate change, the country is severely affected by extreme weather conditions. Mosquito-borne diseases like dengue may be particularly sensitive to changes in global and local climates.
Economic/Tourism Impacts
We can’t stress enough how dengue adversely impacts the country’s economy. A study in 2015 estimates that between 2008 and 2012, dengue cases in the country brought about a direct medical cost of $345 million yearly (what with the loss of productivity caused by the illness and pre-mature death, increased healthcare costs, and a possible decrease in tourism — dengue surely can scare away foreign visitors).
It is reported that 65 percent of dengue cases end up in the hospital with an average stay of four days at up to $565 per day, which is roughly equivalent to a month’s income for the average Filipino family.
Now comes Dengvaxia, the dengue vaccine licensed for the prevention of all four serotypes of dengue in individuals nine to 45 years old. Asia (which includes the Philippines) bears 70 percent of the global disease burden of dengue and Sanofi Pasteur is committed to making the vaccine available first to those that live in endemic areas (like the Philippines).
Note that the vaccine was studied for safety and efficacy (all of 25 studies) against all four dengue virus types among 40,000 people from 15 countries, and the Philippines participated in all three phases of the clinical trials.
Long, Hard Work
“We’ve been working on this vaccine for a very long time,” Dr. Alain Bouckenooghe points out. “We’ve been working intensely with a large external team of experts, investigators, and professors in the Philippines, Thailand, and many countries and an internal team of experts diligently, shared information transparently, but when you look at what’s been published or put in media, it’s not reflecting the reality.”
It’s certainly been a long, long journey with “a multitude of people and collaborations” and not just Sanofi’s single-handed work. “We’ve been working on the dengue vaccine for 21-22 years,” recounts Dr. Alain. “We didn’t know much about dengue in the early days, there was trial and error, the early vaccine didn’t work as well. Finally, there’s a vaccine that’s now available.”
He’s quick to add, “Why was it so complicated to come up with a dengue vaccine? There are a few things about dengue specifically that make it harder, compared to other diseases, to get a good vaccine. One thing is there are four different serotypes and typically, it’s your second infection that puts you at the greatest risk to get very serious dengue. That’s where people get hemorrhagic fever, get admitted to the hospital. So, when you get the vaccine you want to protect yourself against all the four serotypes. You can very easily make a vaccine against one strain only, they started that in the 1940s ... But what was not possible at that time now seems possible.”
Here’s more from what we gathered at the Sanofi Pasteur press conference. Dengue is the fastest-growing infectious disease and the greatest number of cases globally occurs in pre-adolescent and adult populations. In clinical trials among at-risk populations of nine to 16 years old, over a 25-month period:
• Two out of three cases caused by any of the four types of dengue were prevented.
• Eight out of 10 hospitalizations were prevented.
• Nine out of 10 severe forms of dengue were prevented.
Note that getting one type of dengue does not make you immune to the three other strains.
With the dengue vaccine serving as a new line of defense to complement prevention efforts by the government, dengue-endemic countries like the Philippines now have a better chance of reaching the WHO objectives of reducing dengue mortality by 50 percent and morbidity by 25 percent by year 2020.
More Dengue (MIS)Information
But was this dengue vaccine introduced haphazardly?
Certainly not, strongly declares former Health Secretary Janette Garin who clears the misconceptions and answers oft-asked questions about the new vaccine at an exclusive meeting with health writers.
Garin gets down to the nitty-gritty, “They’re saying minadali daw. The office of Senator Richard Gordon (who’s conducting a hearing on this) was misinformed. Even during the time of Health Secretary Enrique Ona, he already wanted to launch the dengue vaccine program, but the licensing of the vaccine at the Department of Health was not yet done. It was already being discussed when I came into DOH. Phases 1, 2, and 3 of the trials were done in the Philippines, but also done in more than 20 countries over a period of 20 years, so hindi yan minadali. It underwent 20 years of study, mahirap gumawa ng bakuna, and this dengue vaccine targets all four strains. Before it was licensed in the Philippines, it was already licensed in Mexico. After the Philippines, it was licensed in Brazil. Brazil and Mexico are WHO-accredited facilities, meaning their laboratories are being used by the World Health Organization. Prior to that, we had several meetings with WHO. I even flew to Geneva to have meetings with the experts in the headquarters of WHO. It’s because the Philippines is one country that has a really high incidence of dengue. And the biggest problem is the dengue we have automatically needs hospitalization, yung tinatakbo sa ospital, because it’s almost always severe. What hurts is that kids get sick and if they don’t get the vaccine, they could die and who will be accountable for their death? We took particular interest in dengue because it’s fatal, not like Zika. The dengue vaccine has been proven and affirmed by WHO to reduce severe dengue by 92 percent and dengue hospitalization by 80 percent.”
A Concerned Mom’s Plea
A concerned mom, Janette laments, “With this misconception being spread that our children are being used as guinea pigs for this vaccine, we’re denying mothers the chance to avail themselves of this free vaccine from the government for their children.”
She tells us, “We made the immunization program school-based so we’re sure the vaccine will really go to school children who can’t afford it and not the rich ones who take advantage. We also targetted areas where dengue has the highest incidence.”
When dealing with this dreaded disease, we have to be proactive, says Garin. “We have to clean up in the schools. But vector control and fogging may not be enough to decrease the effects of dengue. This is where immunization awareness comes in. It’s like dealing with poverty — if you want to address it, you just don’t give people jobs, you look at their education, livelihood, health.”
Now, if only there’s a vaccine that could prevent ignorance, poverty, apathy, and war in this world!
