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[av_heading heading=’UNSAFE VACCINE? DOH halts dengue vaccination ‘ tag=’h3′ style=’blockquote modern-quote’ size=” subheading_active=’subheading_below’ subheading_size=’15’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” admin_preview_bg=”]
BY ADRIAN STEWART CO
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MANILA – The Department of Health (DOH) has suspended the dengue vaccination program started during the term of then Health secretary Janette Garin after the pharmaceutical company that manufactured the vaccine admitted safety issues with it.
According to French pharmaceutical company Sanofi Pasteur, its Dengvaxia works as expected in people already exposed to the dengue virus; but in those who haven’t, the vaccination is linked to an elevated risk of severe disease developing from a subsequent dengue infection.
Health secretary Francisco Duque III said yesterday they were reviewing and consulting with experts, key stakeholders and the World Health Organization with regards to Dengvaxia.
Dengvaxia, approved for use in individuals from nine to 45 years of age, is the first vaccine in the world licensed for the prevention of dengue. It is manufactured in a dedicated Sanofi production site in France.
In December 2015 Dengvaxia was licensed for use in the Philippines by the Food and Drug Administration.
DOH, then headed by Secretary Garin of Iloilo, bought from Sanofi P3.5-billion worth of Dengvaxia and started a public dengue immunization program in March 2016 targeting public elementary school pupils that are at least nine years old.
Garin, a medical doctor by profession, could not be reached for comment as of this writing.
Sen. Nancy Binay urged DOH to conduct public health surveillance to avoid a “medical disaster.”
The public dengue immunization was initially carried out in three highly endemic regions (Regions 3 and 4-A and National Capital Region) with some 700,000 individuals receiving at least one dose of the vaccine in 2016.
Parents needed to know the circumstances surrounding the vaccine, what symptoms should be monitored, precautions, indications, contraindications, side effects and possible adverse effects, said Binay.
“Obviously, there were shortfalls and gaps in the vaccine’s safety profile. Sanofi is morally and ethically obliged to inform the public what severe diseases came out in their clinical tests,” said Binay.
Dengue hemorrhagic fever is an acute viral infection that affects infants, young children and adults. It is transmitted by day-biting mosquitoes that live and breed in clear, stagnant water.
Duque assured the public that “DOH is highly committed in strengthening and intensifying its ongoing surveillance and monitoring to evaluate the dengue vaccine program and ensure safety.”
DOH, on Wednesday, received information from Sanofi that the vaccine has shown consistent and sustained benefit for those who were previously infected with the dengue virus. But severe cases may occur to those who were injected with Dengvaxia but have not yet been previously infected with dengue virus.
“DOH assures the public that it is serious in carrying out its mandate to always guard the health and well-being of its constituents. Thus, it shall ensure that vaccines are always safe and effective to optimize its health benefits,” said Duque.
According to the Sanofi website, Dengvaxia is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in clinical studies (phase I, II and III).
The Philippines participated in all three phases of the clinical development of Dengvaxia, according to Sanofi.
“Asia currently bears 70 percent of the world’s dengue burden; in the Philippines alone 200,000 cases of dengue were reported in 2013. A new analysis published in the New England Journal of Medicine on 24th March (2016) reports that the Philippines had the highest incidence of confirmed dengue in the 10 endemic countries that participated in the clinical efficacy studies for Dengvaxia. The analysis also reported that up to 15 percent of febrile disease in children nine years and older in the Philippines is due to dengue,” according to the Sanofi website./PN
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