DENGVAXIA

Proper Name: Dengue Tetravalent Vaccine, Live

Tradename: DENGVAXIA
Manufacturer: Sanofi Pasteur Inc.
Pharmacotherapeutic group: Vaccines
Indication: DENGVAXIA is a vaccine used to prevent dengue fever caused by dengue virus
serotypes 1, 2, 3, and 4. DENGVAXIA is authorised for use in people aged 9 to 16 with laboratory-
confirmed previous dengue infection who live in endemic areas.

Introduction
Dengue disease is a mosquito-borne tropical illness brought on by the dengue virus. Most people
who contract dengue disease experience mild, and flu-like symptoms. However, some patients
develop severe disease, possibly fatal bleeding, and organ damage. People who have been infected
twice are at an increased risk of developing a severe illness. Dengue virus comes in several
varieties (serotypes), and Dengvaxia protects against serotypes 1, 2, 3, and 4.
The vaccine is administered in three doses, six months apart. The upper arm is the preferred site
for administering the injection under the skin. Moreover, only with a prescription is Dengvaxia
available, and it should only be taken as directed by health authorities.
Limitations of use:
• DENGVAXIA is not recommended for use in those who have never had dengue virus
infection or whose serotype is unknown. When vaccinated and then exposed to the dengue
virus, those who have never had the disease are more likely to get severe dengue fever. A
previously laboratory-confirmed dengue infection may be detected through a patient's
medical history or by serological testing done before vaccination.
• DENGVAXIA has not been proven to be safe or effective for people who reside in dengue-
free areas and travel to dengue-endemic areas.
The Dengue Vaccine Dilemma:
2016

• Dengvaxia had a high-profile launch in the Philippines in the spring of 2016. The nation
had participated in every stage of clinical development and was the first in the world to
access it. To immunize a million kids by the end of the year, the Department of Health
launched a mass vaccination program and spent $67 million on Dengvaxia.

Dengvaxia, whose development had taken 20 years and cost roughly $1.8 billion, was also
expected with great anticipation by Sanofi. Sanofi appeared to be in a good position to
profit from providing the first-ever dengue vaccine to international markets because
officials estimated that the vaccine, which helps protect against all four serotypes of
dengue, would reduce infection rates by 24% within the following five years. Ten other
nations, including Mexico, Brazil, and Indonesia, were granted regulatory approval for
Dengvaxia by October 2016.
2017
• More than six months later, after more than 830,000 children had received at least one dose
of the vaccine (Dengvaxia is administered as three injections, with six-month intervals),
Sanofi announced that it was changing its label to restrict its use to only those who had
already been exposed to dengue virus. Having reanalyzed its trial results, Sanofi said the
evidence now suggested that dengue-naïve people who received the vaccine could be
vulnerable to more severe infections.
2018

• The possible effects of the vaccination program quickly escalated into a national scandal
for which pharmaceutical companies and health department officials were held
accountable. Following allegations that the vaccination was responsible for many child
deaths, the Philippines Public Attorney's Office sued Sanofi executives, government
authorities, and the vaccine's distributor, Zuellig Pharma, in February. The lawsuit
demanded compensation for the claims that a 10-year-old girl passed away after receiving
the vaccination even though she had a pre-existing ailment.
2019

• There is no evidence linking Dengvaxia to the deaths at the center of the allegations. The
vaccine's subsequent authorization by European and American authorities validates
Sanofi's claims that it is safe and effective when administered correctly.

Nonetheless, the controversy in the Philippines raises troubling questions about the
governance of this immunization drive and how the vaccine was allowed to be administered
to those who may have been harmed by it despite years of clinical studies. A vaccination
campaign without solid safety data and careful management could easily be viewed as an
exploitative gamble on public safety.
Reflection:
Dengvaxia is a vaccine used to prevent dengue disease and is recommended for nine years old and
above. Dengvaxia aids the immune system in fighting and preventing dengue disease. It was first
introduced in the Philippines, where it was administered to over 800,000 children as part of a
school-based campaign. Due to concerns over how the vaccine affected those who had never had
the disease in 2018, the Philippine government ended the program since Dengvaxia is indicated
for individuals who have had the disease. Still, the warning of Sanofi was too late. In addition,
there are news saying some children died after receiving the vaccine.
In 2015, Hadinegoro studied "Efficacy and long-term safety of a dengue vaccine in regions of
endemic disease" showed that Dengvaxia causes harm and hospitalization in children under nine
years old especially 2-5 years old. This study pertains that there is something wrong with the
vaccine but since it is endemic in our country, some individuals tried to have the vaccine although
it has not been tested or proven effective. It should first undergo various clinical trials, studies and
examinations to prove that it is safe. Also, the manufacturer of this vaccine should provide clear
instructions, warning, and correct information to the public to raise awareness regarding the
indication of the vaccine since it may affect millions of our children.
Lastly, those children who died after receiving the vaccine deserve justice. This health issue leads
to fright among parents. This greatly affects some of the programs of DOH, as a result, only few
wanted to be vaccinated.

Reference:
https://www.pharmaceutical-technology.com/analysis/dangvaxia-
philippines/?fbclid=IwAR3SF0aa00TBNBgwFK20jOi8hzxwaX9dFIKo7WGuTG287e5kpqi6Cz
nM1e4
https://www.ema.europa.eu/en/medicines/human/EPAR/dengvaxia?fbclid=IwAR2i5Vu6S7yHFt
wrXpEqlAiuW_mEXRlQCFiYS4h8VBqjajAJPjPR17qvzQg
https://www.fda.gov/media/125157/download?fbclid=IwAR2FtetmLV6v-
01UdqMYvWrCTuyP_sCgD_t0gAp2lqMvP2Yo104TG6wfFrc
https://www.ema.europa.eu/en/medicines/human/EPAR/dengvaxia?fbclid=IwAR3VpcnqEugSg
VpVyep9JIM_12b0TFTfBXvthH1AF1QFpocQwMwW7JG3Q34