Categories · Health

‘Undue Haste?’

Objection to dengue vaccination mounts; Health officials ‘negligent’—Sen. Gordon

It seems like the debate on whether dengue vaccine program should be continued or discontinued is far from over as the House of Representatives and Senate continue its inquiry into what has been described as “undue haste” in providing the dengue vaccine worth Php 3.5 billion to 1 million children.

The Philippines is the first country to embark on a public immunization campaign through the Department of Health and one of the four that have approved the vaccine – which includes El Salvador, Mexico, and Brazil.

The first Dengue Vaccine Program was launched by Sanofi Pasteur in the Philippines last April 2016 and now, it is hounded by controversy following the death of two pupils who received the first dose of the vaccine in April.

Health experts, advocates, and civil society have called for the suspension of the implementation of the vaccine program due to questions on its cost-effectiveness, safety and ethics.

Reasons for suspension

In a position paper on the Dengue Vaccine Program of the Department of Health (DOH) dated November 28, 2016 signed by Fabian M. Dayrit, acting president and academician of the National Academy of Science and Technology, the following reasons for recommending its suspension was cited:

  1. There is lingering uncertainty about the long-term safety of this new vaccine against dengue fever. Evidence from the manufacturer’s trial shows that there may be a paradoxical increase in the incidence of severe dengue beginning a few years after children are vaccinated, and possibly continuing for the rest of their lives. This danger applies especially to children who have never had dengue fever before.
  2. The cost-effectiveness of this dengue vaccine program is doubtful. A cost-effectiveness study assessing potential use of the dengue vaccine in the Philippines was done but was funded by the manufacturer (Sanofi) rather than by an independent body. This study was biased in that there were clear measures to minimize expenses (it did not account for the potential cost of increased disease severity arising from the vaccine), and maximize savings (effectivity was assumed to last 10 years when it is clear that protection wanes by the third year).
  3. The current program is not a feasible strategy for easing the dengue burden in the entire country. The cost of this initial program of PhP 3.5 billion will cover only 1 million children in three regions, which represents a small fraction of Filipino children. National scale-up of this expensive program is simply not a viable option for the country.
  4. Community preparations for the implementation of the vaccination program are inadequate. From the time the Formulary Executive Committee (FEC) issues guidance, it usually takes 12-18 months to prepare health workers and communities to introduce a new vaccine. Administrative orders and guidelines need to be issued to local government units. Field manuals need to be produced and translated into dialects. Health workers need to be trained to give the vaccine and answer questions from parents and children. Referral systems for adverse events need to be activated and tested, a research protocol for monitoring on adverse events should be in place. These could not have been done in 26 days. Thus, it is doubtful that there is adequate community preparation.
  5. Vector control remains the most important and effective response to dengue.

‘Negligence’

Meanwhile, Senator Richard Gordon, chairman of the Senate Blue Ribbon committee, described the decision to implement the school-based immunization program as “negligence” which former and current health officials must be accountable for.

Sen. Gordon is leading an investigation on the P3.5-billion worth of dengue vaccines that had been administered by the DOH. It was noted that the process did not pass through the prequalification requirements of the World Health Organization (WHO).

The death of 11-year-old John Paul Rafael, who died last April 11, days after receiving the anti-dengue vaccine, was also tackled during the hearing. Rafael was known to have a congenital heart disease.

“It’s quite tragic that we have to lose some patients because of this,” Sen. Gordon was quoted in a media report. He was also not convinced that health officials exercised due diligence in evaluating the new vaccine.

“It behooves us in the government to see to it that when we get this kind of medication, we get the best and the brightest to see to it that we examine the tests and we examine the due diligence required,” he said.

However, former DOH Secretary Janette Garin countered by defending the vaccinationprogram. According to her, the schoolboy’s death was not due to the vaccine. She agreed though that the health workers who administered the vaccine should have exercised due diligence to check the overall physical condition of the patient by examining him.

Health Secretary Paulyn Jean Ubial told the media that the DOH will continue the current dengue vaccination program  only in those who received the initial dose already. Three doses are required to complete the vaccination. She vowed to “fix the system.”

The vaccine branded as Dengvaxia were first administered in April 2016. Health advocates believed it was done prematurely, citing the lack of recommendation from the WHO’s Strategic Advisory Group of Experts (SAGE).

Doctors Garin and Ubial said that there was no legal requirement to get a certification from the WHO. Sec. Ubial explained a WHO certification is only required for United Nations (UN) procurement agencies, like the United Nations Children’s Fund, United Nations Development Programme, and the United Nations Population Fund.

Dr. Antonio Dans, academician of the National Academy of Science and Technology, who was also one of the resource persons during the hearing,  warned of the potential long-term dangers of dengue vaccines.

“Years later as the child grows, antibodies can expose them to severe dengue…This is not my theory. This is the theory when the trials were conducted,” Dr. Dans told the committee.

Dr. Garin countered Dr. Dans, saying it was just that, a theory, and it was not proven on the trials on at least 20,000 children.

 

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