"Bear in mind that the wonderful things you learn in your schools are the work of many generations, produced by enthusiastic effort and infinite labor in every country of the world. All this is put into your hands as your inheritance in order that you may receive it, honor it, add to it, and one day faithfully hand it to your children. Thus do we mortals achieve immortality in the permanent things which we create in common." - Albert Einstein

Saturday, December 2, 2017

It Is Our Responsibility

Facing a worrisome dengue epidemic, the Aquino administration approved the use of the Dengvaxia vaccine in December, 2015. Its Department of Health, a few weeks later, launched a massive vaccination program of more than 1 million children, costing 3.5 billion pesos. The Health Secretary, Janette Garin, was touting that the vaccine earned approval from the World Health Organization. With a change in administration, the new Health secretary, Paulyn Ubial, suspended the vaccination program in July 2016, citing that the vaccine has not been proven safe. However, on September 2016, Ubial issued a certificate of exemption for Dengvaxia amidst continuing issues. This timeline was provided by Rappler.

Above copied from Rappler

It was nice for Rappler to provide a timeline. However, as usual, Rappler fails to provide important information for an issue that is of utmost significance. First, the World Health Organization does not have the authority to approve vaccines. That authority falls solely on the shoulder of each country's drug regulatory body. This is a misconception that is sometimes present in scientific journals but has been corrected:

"In his article in The Journal of Infectious Diseases, Halstead stated in the title that “WHO approves the CYD-TDV dengue vaccine”. This statement is misleading, and it is hence important to elaborate on the role of the World Health Organization (WHO). It does not fall under the purview of the WHO to approve vaccines; the power to license vaccines belongs to national regulatory authorities who follow their own rigorous evaluations and approval processes on the basis of the quality, safety, and efficacy of the product." (Journal of Infectious Diseases, December, 2016)

One must note, however, that the actual title of Halstead article is "Critique of World Health Organization Recommendation of a Dengue Vaccine" and not "WHO approves the CYD-TDV dengue vaccine”. A recommendation is different from an approval. Halstead, is in fact, very wary of WHO's recommendation. In a letter published in the same issue of the journal, Halstead adds:

"For dengue virus (DENV) infections, almost all hospitalizations in the placebo group are expected to result from secondary infections. But what about the 295 vaccinated children who were hospitalized for dengue after the onset of clinical trials [2]? Given that children aged 2–5 years had vaccine-enhanced disease..."

Although Halstead's article was only published in August, 2016, issues regarding Dengvaxia have been known before the Aquino administration in the Philippines approved the vaccine in December 2015:

"... there were more hospitalizations and cases of severe dengue reported among participants under the age of 9 years than among those older than 9 years of age in the vaccine group... ...Available clinical data are insufficient for drawing definitive conclusions about the observed imbalance in younger children...." (New England Journal of Medicine, July, 2015)

There are obvious reasons for concern. And the Aquino administration bears the responsibility of performing due diligence. Fast forward to Novermber 2017, the maker of the Dengvaxia vaccine finally issues a press release:

"For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection." (Sanofi Pasteur, Press Release, November, 2017)

The Dengvaxia vaccine is a simple illustration of how the Aquino administration handled a problem without doing its homework. This example is no different from how it handled the challenges faced by its basic education system. The Aquino administration is known for jumping into consequential decisions without looking closely at evidenced based research. Such irresponsibility not only costs billions of pesos but also harms Filipino children.

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