THE government decision to use Dengvaxia, the French-made anti-dengue vaccine, on Filipino grade-four schoolchildren without adequate precautionary measures, has become a scandal of monumental proportions after its manufacturer Sanofi-Pasteur recently revealed that it could cause severe, even fatal, infection on those who have not been infected before vaccination. Some 830,000 schoolchildren have reportedly been vaccinated under the anti-dengue immunization program; from January to September 2017, the Department of Health was reported to have recorded 97,287 dengue cases nationwide.
Dengue is the world’s fastest-growing mosquito-borne disease, which infects no less than 400 million victims a year. The World Health Organization (WHO) has not recommended any vaccine for national immunization and recommends that countries consider vaccinating people only in national or subnational geographic areas where data indicate a high degree of dengue infection.
In April 2016, WHO released a “series of criteria” for governments contemplating to use the vaccine. Individual experts like Dr. Scott Halstead, founder of Pediatric Dengue Vaccine Initiative in the US, and acknowledged world leader in dengue research in the last 50 years, are known to have warned that dengue could be caused by an anti-dengue vaccine.
The story of a vaccine
In 2015, Sanofi-Pasteur, the vaccine producing arm of the Sanofi-Aventis Group, the world’s third largest pharmaceutical group after Pfizer and GlaxoSmithKline, announced it would develop an anti-dengue vaccine. This was received with high hopes in the pharmaceutical world, given the fact that an effective dengue vaccine had eluded scientists for years. The reason being, the immune response to the disease is complex. While the body develops immunity to other viruses after a single episode, in the case of dengue the risks are multiplied. The dengue virus has four sero-types. This means four different forms of the virus, which are distinct from each other, although related.
Instead of developing immunity to dengue after the first infection, people could get sensitized and actually have a more serious course if and when they get dengue a second time, my medical consultant from Cornell points out. They could get dengue four times because there are four different forms of the virus. This makes designing a dengue vaccine extremely difficult because you would be exposing a person to a type of dengue which would prevent them from getting that type in the future, but not the three other types.
Apparently, the Sanofi data looked promising, but before WHO and the relevant medical societies could weigh in on the merits of the vaccine and help the DOH decide whether or not to include it in its vaccination program, President B.S. Aquino 3rd decided, through his health secretary, Janette Garin, to procure P3.5 billion worth of the vaccine and start administering it to the Grade 4 schoolchildren. This was nothing new for Aquino, who had earlier decided to flood the market with chemical contraceptives, despite the people’s overwhelming opposition to state-administered population control, after talking to then US President Barack Obama, and receiving a $454-million grant from the Millennium Challenge Fund.
Not for the First World
Dengvaxia is administered via injection under the skin in the upper arm, in three separate doses, six months apart from each other. It has not been approved for use in Europe or in the First World. In April 2016, Sanofi applied to market the vaccine in Liechstentein, Norway and other European countries, but decision on this application is not expected from the European Medicines Agency until the second quarter of 2018.
However, in December 2015, it was licensed in Mexico for people aged 9 to 45, living in areas with a high level of dengue infection. At the same time, at Garin’s initiative, it was approved by the Food and Drug Administration for use in the Philippines. With its purchase of 1 million units of Dengvaxia, worth P3.5 billion, the Philippines became—in Garin’s words—“the first country in the world to introduce, adopt and implement the dengue vaccine through the public health system in a public school setting.”
No vaccine, no grades
The vaccine was administered without providing doctors enough information about it; without requiring the consent of parents before their children were vaccinated; without providing a forum where they could ask questions. They were directed to talk to the school principal, who probably knew nothing about the vaccine, if they had any questions. It was also strongly rumored that the schoolchildren were told they would not get their report cards if they refused vaccination.
Months before that, in May 2015, Garin traveled to Paris on a mysterious trip which the Philippine Embassy knew nothing about until the French foreign ministry at Quai d’Orsay told them about it. It was only after the embassy inquired directly from the Department of Health in Manila that it got the details of Garin’s visit before she arrived at the French capital. The trip was reportedly paid for by the European Union in connection with the World Health Assembly.
In Paris, Garin had dinner with Guillaume Leroy, vice president of Sanofi’s Dengue Vaccine Program, Jean-Antoine Ziusou, senior director for Sanofi’s Vaccination Policy and Advocacy, and Ching Santos, Sanofi’s country manager in the Philippines. The next day, Garin was given a tour of the Neuville Dengue Facility in Lyon, eastern France.
Secret in Paris
Garin initially refused to disclose her meeting with Sanofi officials until the media started quoting the Philippine ambassador’s report to the Home Office about her visit. She insisted she had gone to France to meet with the French health minister, nothing more. However, Ambassador Theresa Lazaro’s report on Garin’s dinner with Leroy on May 14, 2015, as seen on ABS-CBN, revealed that Garin and the Sanofi officials discussed not only the price of the vaccine, but also how to create a demand for it in the Philippines, and a “strategy” to justify its inclusion in the succeeding Philippine annual budgets.
Garin also suggested that the private sector launch the vaccine in the Philippines, according to the report. “A private launch and widespread ‘private use’ will create demand for the vaccine and thus pave the way for the DOH to include it in the succeeding years’ budget,” the report quoted Garin as saying.
In May 2015, nothing official had been said about the Dengvaxia vaccine. But because of Garin, the Philippines participated in all phases of its clinical development with subjects from Cebu and Metro Manila. Having acquired its 1 million units of the vaccine in December 2015, the DOH began providing free vaccines to selected Grade 4 public school pupils in Metro Manila, Central Luzon and Calabarzon, the three regions with the highest number of dengue cases, in April 2016.
At the same time, consistent with Garin’s idea of creating demand for the vaccine by involving the private sector, Sanofi started promoting the prescription drug over the counter. Watson’s Personal Care Stores became the main channel for it throughout the Philippines. In May 2017, the FDA ordered Sanofi and Watson’s to stop promoting and offering immunization services without proper authorization.
Concern expressed by epidemiologists (some of which has appeared in the Journal of Clinical Epidemiology) ultimately prompted Sanofi to acknowledge problems related to the vaccine. After repeatedly denying her secret meetings with Sanofi officials in Paris, Garin finally owned up, but tried to pass the buck to her predecessor Dr. Enrique Ona, whom she now blames for having initiated the idea of adopting an anti-dengue vaccine. Critics have excoriated Aquino and Garin for the mess, saying they might have benefited financially and politically from the transaction. This occurred on the eve of the 2016 presidential election when the administration needed to raise funds for its presidential and senatorial candidates.
Congress had not authorized the purchase, so disbursing P3.5 billion by mere “authority” of the Department of Budget Management violated the Constitution, which provides that no money may be released by the Treasury except in pursuance of an appropriation authorized by law. But more than the money is the health and well-being of at least a million young Filipinos. It could mean the loss of an entire generation.
Dragging DU30 in
But although Aquino and Garin may have a lot to answer for, they may have succeeded in dragging the present administration into the whole mess. It is now claimed that of the 830,000 children who had been vaccinated, only 350,000 were supposed to have received it during the time of Aquino and Garin. The greater number was said to have been vaccinated during the short-lived watch of DU30’s Health Secretary Paulyn Jean Rosell Ubial, whose nomination was rejected by the Commission on Appointments.
But highly informed sources claim Ubial had acted under pressure from privileged and powerful members of Congress, who had pressed her to accelerate the anti-dengue program when it seemed to have stalled. These included a media-oriented member who has since accepted an executive position, the sources said.
The same sources claim that one House committee has decided to suppress its report on its investigation of the vaccine controversy, and against mounting calls for a more thorough probe of the scandal, Speaker Pantaleon Alvarez has been heard to say there will be no such thing. The House is much too busy trying to impose all sorts of radical legislation on the nation, without consulting or involving the Filipino people.