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Sanofi Won't Refund Used Doses of Dengvaxia Plus FAQ on the Investigation
  • After Malacañang announced its support of the initial results of the investigation by the expert panel from the University of the Philippines - Philippine General Hospital (UP-PGH), Sanofi Pasteur states that it “respectfully declined” to refund used Dengvaxia vaccines and provide financial support for the hospitalized vaccinated children. Sanofi, however, has agreed to reimburse unused Dengvaxia vaccines. 

    In a statement provided to SmartParenting.com.ph, the company reiterated that “there are no safety or quality concerns about the Dengvaxia vaccine.” Echoing the findings of the UP-PGH panel, a group independent of the Department of Health (DOH), the pharmaceutical company added, “There is no evidence directly linking the Dengvaxia vaccine to any of the 14 deaths.”

    “Agreeing to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case,” said Sanofi, adding that the dengue vaccination in the Philippines will still reduce dengue disease in the country.

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    While it is refusing to provide a refund, Sanofi is making a counterproposal saying that it is willing to offer free vaccines if the national dengue vaccination program is brought back. “If the Department of Health decides to reinstate the community-based dengue vaccination program following a complete evaluation of the new data on the vaccine, Sanofi Pasteur would be willing to provide new doses of the vaccine free of charge.” 

    “These new doses would allow people who previously received one or two doses of the vaccine in the public program to complete the 3-dose schedule,” the Dengvaxia maker said.

    The DOH has said that it will rely on the UP-PGH Dengue Investigative Task Force for official data on the deaths of the 14 children vaccinated with Dengvaxia. Malacañang echoed its support as well in a media briefing on Saturday, February 3.

    “Their first report provides a bit of relief for parents because it doesn't look like the 14 deaths were caused by the Dengvaxia vaccine,” said presidential spokesperson Harry Roqueaccording to Rappler.

    “Definitely the PGH expert panel handled it very, very well — beyond even all the expectations of the Department of Health,” said Undersecretary of Health Enrique Domingo, reported Rappler in a separate story. “We were surprised at how scientific and how thorough the evaluations were. And at this point, this is the evidence that we are taking into consideration.”

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    Updated FAQs on the recent dengue case findings and more

    #1 What were the results of the UP-PGH investigation on the 14 vaccinated children?

    • 3 died of dengue despite being vaccinated with Dengvaxia. Two cases were suspected of "vaccine failure," which means Dengvaxia might have failed, but it did not necessarily mean the vaccine caused the death of the children. According to the press release from the DOH, these cases require "further testing of tissue samples and antibodies" to complete the investigation. (We reached out to doctors who have no connection to the panel to weigh in on the press release, but we have yet to receive a reply.)

      Two of the three children received all three doses of Dengvaxia. The third child received only the first dose of the vaccine and fell ill days after receiving the shot, said pediatrician Dr. Juliet Sio-Aguilar, the head of the PGH expert panel. It is possible “that the child was already incubating a dengue infection when given the vaccine,” she said in an Inquirer.net report. 

    • 9 died of other causes including congenital heart disease, brain infection, pontine hemorrhage and cardiac arrhythmia

    • 2 cases remain unknown “due to inadequate information available”

    #2 Should we set aside findings of the Public Attorney's Office (PAO) that held its separate investigation? 
    In our opinion, the responsible thing to do is for PAO to share its findings with the UP-PGH team. As of this writing, PAO chief Persida Acosta has refused to do so. 

    #3 Do the findings mean Dengvaxia will be available again soon?
    The Food and Drug Administration (FDA) has suspended the sale of Dengvaxia in the country for a year. DOH has yet to decide if Dengvaxia will be included in the national dengue immunization program. 

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    On the other hand, a group of doctors and scientists have asked not to pull out the vaccine from the market, explaining that Dengvaxia provides “persistent, long-term protection” to those who have been infected with dengue. The next step, instead, is to wait for a “quick and cost-effective way to determine whether a person has had dengue in the past or not.” (Read about it here.

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    #4 Amid the controversy, what are the expert recommendations for Dengvaxia now?
    The Pediatric Infectious Disease Society of the Philippines (PIDSP) and the World Health Organization (WHO) recommend administering the anti-dengue vaccine to those 9 years old and above and who have had dengue in the past. 

    “WHO recommends vaccination only in individuals with a documented past dengue infection, either by a diagnostic test or by a documented medical history of past dengue illness,” said the organization. The PIDSP said the same, adding that a discussion with a child's pediatrician is also a must prior vaccination.  

    Medical groups released updated recommendations after the most recent findings on Dengvaxia were released by Sanofi (read about it here).

    #5 What can we do to protect our kids from dengue?
    Whether vaccinated or not, parents should continue to practice anti-dengue measures including applying insect repellent lotion and destroying possible mosquito breeding grounds. If your child was given Dengvaxia, familiarize yourself with dengue symptoms. Immediately consult with a doctor if you suspect your child is infected with the mosquito-borne disease. 

    #6 Should we worry about the other vaccines our children get?
    No. The unfortunate result of the Dengvaxia controversy is that it has made people fear other vaccines and public health programs, reported Inquirer.net. “Vaccination rates are suffering,” said Undersecretary Domingo. The turnout for the first DOH deworming program of the year was “very low” and immunization programs for diseases like polio, measles, tetanus and diphtheria have also been affected. “The parents are really afraid, but this doesn’t mean that we should be paralyzed with fear,” he said.

    Just November last year, the Philippines successfully eliminated maternal and neonatal tetanus through successful vaccination coverage. This means “there is less than one case of neonatal tetanus per 1,000 live birth in every region.” WHO estimated the disease killed 34,000 newborns in 2015 alone,

    The recent measles outbreak in Davao, which has already taken the lives of 4 children and infected 224, shows just how crucial vaccination is to our children.

    Stick to your baby's immunization schedule for his protection. 

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