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The vax on both your houses

Worse than any natural cataclysm is a disaster created by humans—take the horror that is the Denvaxia uproar.

As of the latest reports in the daily newspapers, more than 830,000 Filipinos have been inoculated with Sanofi Pasteur’s CYD-TDV—better known as Dengvaxia, a live-attenuated tetravalent recombinant vaccine Sanofi Pasteur developed to combat the four strains of dengue fever. Sanofi-Pasteur is the vaccines unit of French pharmaceutical firm Sanofi.
Simply put, the term “live-attenuated, tetravalent recombinant vaccine” means that the vaccine contains all four dengue virus strains—albeit weakened viruses.

A Reuters report dated Oct. 4, 2016 quoted a statement issued by Sanofi Pasteur, where the pharmaceutical firm announced that Dengvaxia received market approval in 11 countries: Mexico, the Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore.

Dengue fever is a mosquito-borne disease caused by four virus serotypes (1 to 4) as categorized by the World Health Organization. The disease is seen as a threat to about half of the world’s population, with some 400 million people believed to be infected annually worldwide.

Over the last year, 14 children died, allegedly as a result of inoculation with Dengvaxia. However, the most recent news reports said only three of the 14 deaths were found to have “causal association” with the controversial vaccine. These reports quoted Department of Health Undersecretary Rolando Domingo as saying these three fatalities “died of dengue despite receiving Dengvaxia.”

WHO POSITION

According to the World Health Organization (WHO) position paper on Dengvaxia issued on July 29, 2016: “Countries should consider introduction of the dengue vaccine CYD-TDV only in geographic settings (national or subnational) where epidemiological data indicate a high burden of disease.”

In that position paper, the WHO said this high burden of dengue disease in specific populations targeted for vaccination must be defined this way: “prior infection with dengue virus of any serotype, as measured by seroprevalence, should be approximately 70% or greater in the age group targeted for vaccination.” This recommendation by the WHO takes into consideration the factors that will “maximize public health impact and cost effectiveness” of such a vaccination program.

The DOH dengue surveillance report covering the period of Jan. 1 to July 16, 2016, recorded a total of “66,299 suspect dengue cases were reported nationwide” during that surveillance period. “This is 22.9% higher compared to the same period last year (53,938).”

These numbers for suspected dengue cases may be high—indeed even one confirmed dengue case is one case too many—but the morbidity numbers do not even make 10% of the country’s population of 103.3 million in 2016. Yet the target population for the Department of Health (DOH) rollout of its dengue vaccine drive is nationwide. Curious, considering that due diligence on the part of the DOH includes reviewing the WHO position papers on such matters.

TIMELINE

According to the timeline of events documented by CNN Philippines on the Dengvaxia kerfuffle, the vaccine in question successfully completed “its two parallel Phase 3 clinical studies, which compare the safety and effectiveness of the new treatment” in 2014. The CNN Philippines timeline also reported “Philippines was among the 10 countries that took part in the study.”

As per the same CNN Philippines timeline, then-President Benigno Aquino III met with Sanofi senior vice president for Asia Jean-Luc Lowinski at the Philippine Embassy in Beijing, China on Nov. 9, 2014—and then-Health Secretary Janet Garin negotiated with Sanofi to reduce the cost of purchasing Dengvaxia.

On Oct. 29, 2015, Sanofi Pasteur submitted its application for Dengvaxia to be included in the Philippine National Formulary of medicines to the DOH, pending the approval of the vaccine by the Food and Drug Administration (FDA).

The Philippine government granted Sanofi its approval for the pharmaceutical firm to market Dengvaxia in the Philippines, making that vaccine the first dengue vaccine to be licensed for use in preventing dengue in Asia on Dec. 22, 2015. The Food and Drug Administration (FDA) approved the drug for the prevention of disease caused by all four dengue types in individuals aged nine to 45 years who live in areas where the risks of dengue infection are high.

As per the CNN Philippines report, by the end of 2015, P3.5 billion had been earmarked by the Department of Budget and Management (DBM) under a Special Allotment Release Order to fund the purchase of Dengvaxia by Garin’s office.

(AP Photo/Bullit Marquez)

The first P3-billion purchase order for these vaccines was made in Jan. 21, 2016 by the Philippine Children’s Medical Center (PCMC) makes a ₱3-billion purchase order for the vaccines without approval from the FEC.

Garin issued a Certificate of Exemption for Dengvaxia vaccines to be utilized in the pilot implementation in the National Capital Region, Region III, and Region IV-A on Feb. 3, 2016. She hosted the worldwide launch of Dengvaxia on Feb. 11, 2016.

A month later, the WHO released a paper saying Dengvaxia “may be ineffective or may even increase that risk in those who are seronegative at the time of first vaccination.”

The CNN report explained that the term “seronegative pertains to people who have not yet had dengue.” The WHO called for further studies into the vaccine.

Despite this, Garin issued a P3-billion disbursement to the PCMC to fund the hospital’s purchase of Dengvaxia on March 8, 2016, which PCMC bought the next day from Zuellig Pharma, the distributor of Dengvaxia in the Philippines.

The school-based dengue immunization program for children aged nine years and older kicked off on April 4, 2016. The inoculation drive would provide the students covered by it with three doses of Dengvaxia administered six months apart.

The WHO released its position paper on Dengvaxia released on July 29, 2016, where the world health body said Dengvaxia “may act as a silent natural infection that primes seronegative vaccines to experience a secondary-like infection upon their first exposure to dengue virus.”

In that position paper, the WHO said the vaccine “may be ineffective or may theoretically even increase the future risk of hospitalized or severe dengue illness in those who are seronegative at the time of first vaccination regardless of age.”

Following the release of this position paper, Garin’s successor, former Health Secretary Paulyn Ubial, temporarily suspended the school-based dengue immunization program. The result was that only the 489,003 students who received the first dose of Dengvaxia received the second and third doses of the vaccine.

Things could have been stopped there, but the DOH moved to continue with the vaccination program in September of 2016.

CNN Philippines reported that, on that same month, “the Medical Research Council Center for Outbreak Analysis and Modelling at Imperial College London releases a study saying Dengvaxia could lead to an increase in the number of cases of the disease if not implemented correctly.”

The CNN Philippines report quoted the center’s director, Neil Ferguson, as saying this: “Unlike most diseases, the second time you get dengue, it’s much more likely to be severe than the first time you get it.”

The Singapore Health Sciences Authority raised concerns over the “postulated risk” of Denvaxia in October 2016, saying that, “[a]s the vaccine is more effective in those who had previous dengue infection, and that there is a postulated risk of severe dengue in those who do not have past dengue infections when they become infected.”

The House of Representatives began its probe into allegations of anomalies in the purchase of the Dengvaxia vaccines in November 2016. The Senate investigation into the vaccines began in December 2016, on the basis that the vaccination project cost was too big and that this was approved without congressional approval.

The second temporary suspension of the vaccination program by Duque, who had just been re-installed as health secretary, took place on Dec. 1, 2017. Duque also asked the National Bureau of Investigation to look into the dengue vaccination program on Dec. 4, 2017. The FDA suspended the sale and distribution of Denvaxia the next day.

THE MESS

Back to the WHO, the global health body said it never recommended that countries use Dengvaxia in national-level immunization programs.

The DOH, meanwhile, is now monitoring 40 cases of children who fell seriously ill after receiving Dengvaxia inoculations, a number that rose from 30 such cases in 2016 and nine deaths allegedly because of the vaccine.

The DOH said it would return over 800,000 unused vials of Dengvaxia worth P1.4 billion to Sanofi on Dec. 7, 2017. It called for a refund of the P3.5 billion it spent on the vaccines the next day and created a task force to look into the program. Both upper and lower chambers of Congress announced they would again probe the dengue vaccination program, investigations that kicked off on Dec. 11, 2017.

Many news reports, commentary on social media and the statements attacking the administration of former President Benigno Aquino III over Dengvaxia have invoked volatile and emotional arguments. They have devolved mainly into unvarnished political attacks on Aquino and the people of his administration, as well as Sanofi Pasteur.

While emotions are understandable when children become the targets of obvious neglect, this is the mess that came of efforts to mount a nationwide dengue vaccination program where the vaccines were apparently given to children kids who were not tested for dengue antibodies prior to the administration of the vaccine. It is only right for the public to cry foul.

If dengue had been a communicable disease against which vaccines are most effective, a nationwide campaign to inoculate the population would have been justifiable. But dengue is vector-borne—you only get it when a dengue-carrying aedes aegypti mosquito bites you and passes the infection directly into your bloodstream. None of the four serotypes are transmitted in any other way but direct injection by mosquito bite.

The WHO itself has recommended that any vaccination efforts be supported by the regular modes of controlling the spread of dengue: By controlling the environment in areas where dengue is endemic—removing stagnant water and denying mosquitoes any place to breed and by destroying the mosquitoes that carry the disease, as well as their eggs and larvae.

Now that the nation is in a state of unreasoning hysteria, the Gordian knot known as Dengvaxia has created unintended consequences: Vaccination rates for other preventable communicable diseases like the deadly childhood diseases measles, polio, etc. have dropped and the resurgence of these diseases is a very real risk.

The worst of this man-made calamity is this: Children are caught in the crossfire because the matter of Dengvaxia has become a political arena where every combatant has put their political convenience above the public interest. That goes for all protagonists and antagonists in this moro-moro of a crisis.

For shame, leave the kids out of the mudslinging, please. G

 

 

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