Health experts, advocates, and civil society groups express concern over the continuation of the dengue vaccination program. They support the decision of the Department of Health to withhold implementation of the program until safety signals are cleared; but will our legislators listen?
Some members of the House of Representatives have motioned to defer the passage of the 2017 budget of the Department of Health (DOH) because of the exclusion of the dengue vaccine, which, according to some medical experts and health advocates, have unproven safety.
During the recent pre-plenary conference on the 2017 DOH Budget at the House of Representatives, Cebu Rep. Gwendolyn Garcia questioned why the DOH is stopping the program when it has already been approved by the previous administration.
“Does a political setting affect the health concern? Perhaps it affects administration but not health needs or risks,” said Rep. Garcia.
It can be recalled that the first Dengue Vaccine Program was launched in the Philippines last April 2016, targeting one million nine to 10-year-old children. For its initial vaccination, the DOH selected three regions: NCR, Regions 3, and 4A – which registered the highest dengue incidence last year.
In 2015, it was recorded that the dengue cases in the Philippines has nearly reached its 150 thousand mark. There were 600 reported deaths from dengue last year. On the first five weeks of 2016, nearly 13,000 cases and 49 deaths were recorded.
Referring to the number targeted to receive the vaccination, Rep. Garcia said that since only 489,003 school children had been given the initial dose in regions NCR, III, and IV, the DOH is still around 50 percent short of the one-million target.
Expert panel on dengue
Last July 21, 2016, the DOH convened a group of experts on dengue to provide technical recommendations on the implementation of dengue vaccine and it approved to stop the first dose of dengue vaccine immunization immediately and only the 489,003 pupils will receive the second and third doses. It also called for enhanced parallel studies to ensure vaccine safety and efficacy of the vaccine.
“Your honor, we will follow processes and protocols of the DOH because that is prescribed by law, and because this is a new vaccine. We need to get expert opinion and guidance on how to move along in the implementation of this vaccine (program),” explained Sec. Ubial.
She added: “In fact, the WHO recommendation came out in July; that is why we had to convene the expert panel to review whether the WHO recommendation is actually complying with the way we are actually implementing the program. We commit to the House of Representatives to actually process the request of the Deputy Speaker in a speedy manner so that we comply with the requirements of the law and the requirements of the due process in expanding the new vaccines before the plenary.”
Rep. Garcia questioned the creation of the dengue expert panel, how the experts were chosen, and who recommended them because out of the eight-member panel of experts, only four agreed on the technical recommendation, and the two refused to sign the resolution due to “conflict of interest.”
The World Health Organizations’ Strategic Advisory Group of Experts (SAGE) on immunization has recommended that a vaccine for dengue called Dengvaxia (CYD-TDV) should be considered for use only in geographic setting with high endemicity as indicated by seroprevalence of approximately 70 percent or greater in the age group targeted for vaccination. SAGE does not recommend the vaccine when seroprevalance is below 50 percent.
‘No choice’ but follow contract?
Rep. Garcia reminded the health chief that the program has already been appropriated for, has already been properly awarded; so it should be implemented by the concerned department in compliance with RA 9184 or The Government Procurement Reform Act.
“You have no choice. You have to buy, to procure, [and] allow Zuellig Pharma to deliver these PhP 3 billion worth of vaccines because that is what the RA 9184 provides,” said Dr. Fernejel Biron of the Fourth District of Iloilo City. “As far as the department is concerned, you are bound to honor and you have no legal basis to renegotiate what was signed by [former] health secretary Janette Garin during her time.”
The agreement was signed between the representatives of Philippine Children’s Medical Center and Zuellig Pharma, and both parties are legally bounded to standby and fulfill their obligations under this agreement.
The 600,000 vials of dengue tetravalent vaccine has a contract price of PhP3 billion. On a three-dose schedule, 600,000 will be divided into 200,000 per schedule. The second and third doses shall be administered after six months.
Rep. Garcia also pleaded for the inclusion of Central Visayas (Region 7), especially in Cebu City, given the highest incidence of dengue case, in the expanded program. But unless there is a commitment from the DOH to continue the program, she motioned to defer the 2017 DOH budget.
The health chief said she will seek the recommendation of the expert panel on the matter.
‘Stop the threat’
In an emailed statement, doctors and other public health advocates urged the House of Representatives members to stop the threat of some legislators to defer the passage of the 2017 budget of the Department of Health because of exclusion of vaccine with unproven safety.
“We welcomed the questions raised by our legislators. Evidence matters, but making hasty health policy decisions on incomplete data puts our children at risk. The fact is, the company, Sanofi, is marketing this drug despite doubts of safety. The continuing vaccine trial is the strongest evidence that the dengue immunization program is premature, and that even the company has some doubt,” said Dr. Antonio Dans, an epidemiologist from the UP College of Medicine who has been analyzing the studies on the dengue vaccine.
“A trial that included Filipinos showed that the incidence of severe dengue increased up to five times more, three years after children were vaccinated,” said Dr. Dans, who is also a member of the National Academy of Science and Technology (NAST) of the Philippines and President of the Asia-Pacific Centre for Evidence Based Medicine.
The group also appealed to the legislators to continue investigating the safety and efficacy of the dengue vaccine that is being administered to children starting this year.
Jo-Ann Diosana, senior economist of the Action for Economic Reforms (AER) and a young mother, urged the investigation of the deaths of two children who were given the dengue vaccine. She said hasty dismissal of the connection to the new vaccine does not do these children justice, and those children whom with their parents entrusted their lives to the government when they agreed despite incomplete information to get the dengue vaccine.
Health advocates support DOH’s decision
Meanwhile, the Sin Tax coalition composed of professional groups and civil society organizations expressed support for the decision of the DOH to stop the dengue vaccine program.
In a statement released to the media, the groups believe several important issues need to be addressed before the program is resumed.
The first and most important issue, according to Sin Tax advocate, Dr. Maricar Limpin, is safety. “There are indications that the vaccine may lead to a paradoxical increase in the incidence of severe dengue fever,” Dr. Limpin added.
This was confirmed by Dr. Mary Ann Lansang, an expert in infectious diseases. Dr. Lansang explained that life-threatening dengue may occur when there is infection for the second time.
“Because a poor response to vaccination may mimic a first episode of infection, there is a risk that severe dengue infection may ensue. This paradoxical response is unlike other vaccine-preventable infections – no other vaccine I know of has that kind of risk for more severe disease by the very infection it is trying to prevent,” she said.
Dr. Leonila Dans, an epidemiologist from the UP College of Medicine agreed. She pointed out that, “Despite reassurance from scientists in Sanofi, statistical analysis of the results show that there is a significant possibility of severe infection.”
Diosana of AER criticized the government’s spending of PhP 3 billion, just for a pilot program involving 1 million children. “PhP 3 billion is the cost of the entire National Immunization Program, which includes all other vaccines for the entire Philippine population. This even represents just the initial cost because children may actually need booster doses three years later,” Diosana added.
Another civil society group, WomanHealth, expressed concern on using public funds for the vaccine that may pose harm and danger to children. “We should not be spending that much in public funds, unless we are sure that the vaccine is safe and effective. As a mother, I am very concerned about the possibility that my child may have a higher chance of getting severe dengue fever,” said May-i Fabros, Young Women Collective Coordinator of Womanhealth Philippines.
During the recent budget hearing of the DOH, Sen. Richard Gordon said there may be a need to investigate DOH’s dengue vaccine program “due to sudden, undue haste in providing the vaccine” and an “awful lot of questions” about the vaccine and this was supported by Sen. Nancy Binay.
In the meantime, the dengue vaccination program remains in the balance, with health officials, experts, and advocates anxiously waiting to which side the balance would eventually tilt.