Opinion

Politics versus Science: Lives Lost as a Lifesaving Vaccine is Left on the Table

Children will die.
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Hundreds more children will die. Their parents don't know it yet, but they will all be dead within a year. The day the appeal for Dengvaxia was denied, our hopes for the reinstatement of a controversial dengue vaccine were dashed. The world’s first dengue vaccine has been hailed as a breakthrough, decreasing severe dengue risk by 93 percent. The United States Food and Drug Administration (FDA) recently joined 20 countries in granting approval, recognizing its value for preventing one of the most widespread killers of children in the world.

Dengue is a complicated disease. There are four kinds of dengue virus, known as “serotypes.” A person can get infected with each serotype only once, and that person becomes immune to that serotype for life. The first infection is relatively mild. The second infection with another serotype is the most dangerous, with a significant risk of developing severe dengue that can cause uncontrolled bleeding and an unsafe drop in blood pressure. There is no effective drug. The third and fourth infections can become severe, but less so that the second one

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Nearly four billion people are at risk for dengue, with about 390 million infections occurring per year. About 500,000 people develop severe dengue, with over 10,000 deaths worldwide. In 2015, Sanofi announced that the world’s first dengue vaccine, Dengvaxia, was safe and effective after having hurdled rigorous clinical trials. It decreased the risk of severe dengue by 93 percent, and decreased hospitalization by 80 percent in children nine years old and above.

The tale of Dengvaxia in the Philippines is a sordid mix of politics, pseudoscien ce, and intrigue. The Department of Health (DOH) is one of the most politicized institutions in this country, and this was personified by former DOH Secretary Janette Garin. Garin is a medical doctor by training, but a politician by profession. Prior to her stint at DOH, she was a member of Congress. With just over a year left in President Benigno Aquino III's term, she decided to use the new dengue vaccine in an ambitious mass vaccination program. With one of the highest dengue rates in the world, the Philippines sees more than a hundred thousand cases a year. The mass vaccination program was seen by many as a reasonable exercise, except that it was launched in an election year that saw politicians routinely seen inoculating children. The expeditious manner in which the Philippine FDA approved the vaccine was unusual, coupled with the rapid release of funds in a government notorious for the glacial release of money. There was a bit of an outcry from some scientists who were concerned that there was some possibility of harm especially for patients who had never gotten dengue before, but this was largely ignored.

In November 2017, President Aquino's chosen candidate had lost. A new health Secretary had continued the mass vaccination program, since the new administration did not see any problems with it. Over 800,000 children had been vaccinated. Sanofi, acting on new data that was generated by additional studies requested by WHO on the safety concerns raised by the scientists, announced that the vaccine should not be used for patients who had not had at least one dengue infection. 

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One of the scientists who had warned on this possibility posted on social media that his heart "bled" for all the children who were put in harm’s way. Media, civil society, and the Public Attorney’s Office (PAO) picked up on this and went into a frenzy. Amid accusations of genocide and the mistaken anticipation of widespread deaths, scientists and vaccine advocates raced to control the fallout, to no avail. The PAO started doing autopsies on children from the vaccinated cohort who died from any cause, and asserted on media that they found “bleeding” and “enlarged organs” consistent with “neurotropism” and “viscerotropism.” The PAO did not provide any detailed tissue analysis or required molecular tests that would explain a plausible link between the deaths and the vaccine. When pressed to share its findings with the DOH and an expert panel from the academe, the PAO refused

Scientists who conducted the clinical trials were hauled to Congress and railroaded, with one member of Congress dressing down an internationally renowned Filipino scientist as being at fault. She was held responsible because it was “her vaccine,” even though scientists have nothing to do with regulatory approval or implementation. In the confusion, the Philippine FDA revoked the certificate of product registration (CPR) of Dengvaxia, ostensibly on technical issues of non-submission of post-approval documentsa charge that Sanofi disputes.

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Vaccine rates dropped precipitously as parents lost faith in government-sponsored vaccination programs. Charges were filed against former DOH officials and the scientists who performed the clinical trials. Meanwhile, updated data from Sanofi showed that the safety issue in those children who had not previously had dengue (seronegatives) was an increase in the risk of severe dengue from 2/1000 cases to 5/1000 over five years, the same as that of an unvaccinated seropositive person. In persons who already had at least one infection, it continued to decrease the risk of severe dengue from 5/1000 to less than 1/1000 over five years. 

The Philippines is highly endemic for dengue, seeing more than 170,000 dengue infections per year. At least 87 percent of children above nine years old has already had at least one infection. Using these numbers and the vaccine efficacy data on the mass vaccination cohort of 800,000 children, approximately 700,000 benefited from the vaccine and 100,000 were put at higher risk for dengue. This works out to about 2,800 less cases of severe dengue among the seropositives, and 300 more cases of severe dengue among seronegatives. This results in an overall reduction of severe dengue by 2,500 cases in the original vaccination cohort of 800,000. 

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In early 2019, the Philippines had one of the largest measles outbreaks in modern history, with about 35,000 cases and nearly 500 deaths. Measles is the most contagious of the vaccine-preventable diseases and is the first disease that surges when vaccine programs start to fail. As cases surged, people flocked back to vaccination centers, a sign that the Dengvaxia panic was subsiding. As the measles cases abated, dengue infections started to soar, with over 188,000 cases and 807 deaths. As hospitals were flooded with dengue cases, President Rodrigo Duterte mentioned that he was willing to study all means possible to address the epidemic, including bringing back Dengvaxia. This galvanized pro-vaccine groups. In the light of the U.S. FDA approval in May 2019, a clamor to bring back the vaccine put increasing pressure on Secretary of Health Francisco Duque III to overturn the revocation of the CPR. Meanwhile, PAO Chief Atty. Persida Acosta was accused of using the Dengvaxia controversy for her own political gain. She is now being investigated by the Ombudsman for misusing funds to create a “large scale attack on Dengvaxia and using skewed autopsy reports claiming the vaccine’s responsibility.”

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A few days ago, the DOH announced that Secretary Duque had denied the appeal of the Sanofi to bring back the vaccine. The press release noted that there was no issue regarding the safety and efficacy of Dengvaxia, but that Sanofi had failed to comply with post-approval requirements. The DOH mentioned that Sanofi can reapply for a new CPR in the future, a process that usually takes a year. In the meantime, the dengue epidemic continues unabated. 

At an average of over 170,000 cases a year and 800 deaths annually, Dengvaxia could have prevented tens of thousands of hospitalizations. Roughly half of the 800 deaths are among children above nine years old, the minimum age for which the vaccine can be given. A vaccine with a 93 percent efficacy for reducing severe dengue would have translated to nearly 400 lives saved. Those are lives that could have been saved, had we not destroyed this vaccine

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We will never know who would have been saved, such is the anonymous nature of missed opportunities. But as a Filipino child lies bleeding and dying in a hospital bed from dengue, his parents will ask physicians like me whether we could have done anything else to save him. My answer will be yes, but our government took that choice away.

 

Edsel Maurice T. Salvana, MD, DTM&H, FPCP, FIDSA is an award-winning infectious diseases specialist and molecular biologist at the University of the Philippines and the Philippine General Hospital. He has written and spoken extensively about the Dengvaxia controversy and has been at the forefront of efforts to restore vaccine confidence and science literacy in the country. As a TED Fellow, he is constantly seeking ways to communicate complicated scientific concepts to a lay audience, and strongly believes that this is the best way to combat pseudoscience and fake news.

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About The Author
Edsel Maurice Salvaña, M.D.
Dr. Salvaña is a multi-awarded infectious diseases physician, health advocate, and TED fellow. He is currently director of the Institute of Molecular Biology and Biotechnology of the University of the Philippines National Institutes of Health.
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