2012-88009 Dagala, Kristine Bianca T.

Insight Paper: Issue about Dengue Vaccine (Dengvaxia®)

Dengue is a febrile illness caused by a mosquito-borne virus. It is the fastest vector-borne disease
in the world endemic in 100 countries. It may be caused by any one of four dengue viruses (serotypes 1-4).
Many dengue virus infections produce no or only mild clinical symptoms. Severe dengue is a relatively
rare but serious complication following dengue infection due to plasma leaking, fluid accumulation,
respiratory distress, severe bleeding or organ impairment. Thus, it is life-threatening. According to the
WHO, the global annual incidence of clinically apparent dengue has been estimated at about 50-100 million
cases, predominantly in Asia, followed by Latin America and to a lesser extent Africa.
Dengvaxia® (also referred to as CYD-TDV), developed by Sanofi Pasteur, is a live, attenuated
recombinant tetravalent dengue vaccine, based on the yellow fever 17D vaccine strain, given as a 3-dose
series with 6 months between each dose. The vaccine has 4 components, encoding for antigens of the four
dengue virus strains. Dengvaxia is the first dengue vaccine to be licensed.

Currently, there is an issue in the Philippines about the mass immunization of Dengvaxia® vaccine and its
correlation to the deaths of the vaccinated Filipino children. After reading articles and watching news, a
documentary and the DOH/PGH press conference, these are my opinions as a pharmacy student:

 In December 2015, Dengvaxia® was first licensed based on the results of two large clinical trials
(Phase 3 trials). The CYD14 trial was conducted at sites in five countries in Asia and the CYD15
trial at sites in five countries in Latin America. From these clinical trials done by Sanofi, it was
found out that an excess of cases of hospitalization due to dengue and severe dengue cases was
seen in those receiving Dengvaxia® in the third year after the first dose, in the age group below 9
years, and mainly in those aged 2-5 years. It may be due to age or because this age group contains
a higher proportion of seronegative individuals. These data are open to the public and Philippines,
as the first Asian country that approved its sale, DOH must know or read this before they are
implementing a mass immunization of a new vaccine which are not yet undergone a full post-
marketing surveillance. As a new vaccine especially a live attenuated vaccine, DOH must be
sensitively assuring the data of the said vaccine and its effects, side effects, adverse reactions and
its drug interactions which are present in the drug’s clinical trials. So for me, Sanofi and WHO
gave all data and information of Dengvaxia®. Sanofi Pasteur Asia may have a mistake in not
working with or guiding/reminding the Philippine government about implementing its mass
 immunizations but it is the prime duty of the DOH to know and ensure everything about the new
vaccine or any new drug before opening or introducing it to the public market.
 Some may also question why are these happening only in the Philippines out of all of the countries
which are using Dengvaxia®. No one knows the exact reason but maybe it is all because of not
following the WHO position paper as soon as it was released. It was said that due to possible severe
dengue effects on seronegative patients, it is advisable to know first the target population.
According to the WHO, age-stratified serosurveys are currently the best method for selecting
populations suitable for vaccination, subnational, age- stratified surveillance data may be used to
help guide vaccine decision-making, preferably a combination of seroprevalence, surveillance data,
and programmatic factors should define the target population. This is opposite to what the DOH
did in the Philippines.
 According to the doctors, signs, and adverse reactions of the Filipino children who had Dengvaxia
will not surely be correlated to Dengvaxia. But I also agree with PGH doctors that these are still
data or evidences in the long evaluation of Dengvaxia issue especially the signs and symptoms
experienced by the children are all the same. More evidences and tests, biopsies should be done
before having a final diagnosis about the cause of deaths of the children. Also, in doing these tests
and procedures, it must be assured the quality of the job done by the authorized physicians,
pathologists or any laboratory technicians.