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Debate about Dengvaxia

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Esperanza I. Cabral, M.D.

Esperanza I. Cabral, M.D.

By Esperanza I. Cabral, M.D.
Former Secretary of Health

 (Part I)

Hundreds of thousands of individuals, mostly children, are affected by dengue every year and even though most people recover from the viral infection without treatment, dengue is one of the most feared illnesses in the Philippines. There are months when hospital pediatric wards are filled to overflowing with dengue or suspected dengue patients straining already overextended hospital services to the limit.

The dengue virus ismosquito borne but mosquito control is easier said than done. Efforts to get the public to reduce mosquito habitats and breeding places such as by frequent emptying and cleaning of water containers, and proper disposal of discarded containers and tires are largely unsuccessful, as are efforts to reduce human-mosquito contact such as by getting families to install screens on windows and doors in their homes.

Given this, news of the development of vaccines against dengue was met with elation by the medical community, particularly the pediatricians. The first of these dengue vaccines to reach clinical application is Dengvaxia.

The results of Sanofi Pasteur’s Dengvaxia Phase III trials in Asia and the Americas demonstrated overall moderate vaccine efficacyagainstdengueofnearly 60% in more than 30,000 subjects in 10 countries: Indonesia, Malaysia, Thailand, The Philippines, Vietnam, Brazil,Colombia, Honduras, Mexico, and Puerto Rico.

No safety issues were observed in a 25-month follow-up period of the dengue vaccine. The side effects noted in subjects who received the dengue vaccine were no different from the side effects observed in subjects who received a dummy injection instead. Monitoring for adverse effects continued even after the Phase III trials were completed.

The vaccine was submittedby the company for licensure, and use indengue-endemic countries, including the Philippines. It was licensed for use in our country sometime in December, 2015.

The Philippines opted to introduce the vaccine in several areas in the Philippines where the incidence of dengue was high, including the NCR, Region 3, and Region 4A. The cost of the dengue vaccines purchased for the program is about P3 billion.

At inception, questions were raised as to the wisdom of mass vaccination of children against dengue by a group of physicians who worried that it was premature, given that they were not sure of the long-term adverse effects of the vaccine.

The Department of Health decided that the benefits of mass dengue vaccination far outweighed the risks and proceeded with the program. More than 800,000 children aged 9 years and above were vaccinated in 2016 and 2017. Most received only the first of 3 doses of the vaccine before the program was discontinued.

The physicians who objected to the program brought their case to Congress and hearings were conducted in the House early in 2017. The House was divided, with some congressmen asking for the suspension of the program and others demanding that it be continued.

In November, 2017, Sanofi Pasteur revised its product information to include a caveat that the vaccine may increase the incidence of severe dengue if given to patients who have not had dengue previously.

A furor, fueled by oppositors to the vaccine who claimed that deaths in children are likely caused by the vaccine, ensued.

In December, 2017, the Senate Blue Ribbon Committee started its own investigation.

Initially, the Secretary of Health, attempted to allay the fears of the public by revealing that among those who received the vaccine, there had been a 93 percent reduction in severity of symptoms, and an 82 percent reduction in hospitalization. He said: “The vaccine has shown consistent and sustained benefits for those who were previously infected with the dengue virus… Let me underscore the fact the even for those who have not had prior exposure to dengue or never had dengue infection and received dengue vaccination, they have a protective period, which is 30 months.”

But the controversy had taken a life of its own and has put not only the dengue vaccination program but the entire immunization program of the DOH in question. Health advocates are now demanding that the entire health care program of the government be put under scrutiny and reformed aggressively. This may be one of the good things that can come out of this scandal.

On (Jan. 29, 2018), the Secretary of Health revealed that he has asked Sanofi Pasteur to refund the full amount that the government paid for Dengvaxia, saying that “the full benefit of the vaccine has not been felt.”

To compound matters, allegations of corruption against the President who approved the purchase of the vaccine, the Secretary of Health who proposed the program and initiated its implementation, as well as the staff of the Department of Health and the Food and Drug Administration have been made. So now it is not just a question of whether the decision to license Dengvaxia and use it quickly in nearly a million children was correct but also whether the decision was made because some people wanted to make money out of the dengue vaccine.

What is my take on all of this?

Perhaps I can summarize my thinking about the Dengvaxia debate by telling you of a text exchange between me and a friend of mine early in December of last year when the controversy flared up.

She asked, “How could the Dengvaxia fiasco happen? TV shows sweet little girls receiving shots. Makes my hair stand on end.”

My answer was, “I’m not siding with anyone, but medical practice, including public health, is a matter of risk-benefit analysis. There are obviously advantages and disadvantages to doing one thing or another and we must make the best judgment call, given the information at hand. In the case of the dengue vaccine, their judgment, at the time that they made it, was it will do good much more than harm. And their decision was actually supported by the WHO. Things change with new findings but the DOH does not have a crystal ball.None of us do. I would not necessarily impute greed, malice, or other deliberately evil intents into their actions. What needs to be done is investigate with an impartial mind and make a judgment after. Of course, those who were harmed, if there were any, will need recompense. Let’s not let emotions get in the way of just and proper decisions.”

(To be continued)

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