Is dengue vaccine safe?

The first Dengue vaccine, CYD-TDV (chimeric yellow fever virus-DENV tetravalent dengue vaccine) with the under Dengvaxia® trademark was approved by the USA Food and Drug Administration (FDA) in May 2019. This  recombinant vaccine able to protect against all four Dengue virus serotypes DEN 1-4. This vaccine licensed  in Mexico in 2015 and then licensed to 20 other countries. This vaccine is produced by Sanofi Pasteur which is given in a 3-dose serial preparation with a schedule of administration at  month  0, 6 and 12.

The CYD-TVD vaccine has been investigated through 2-phase in 3 clinical trials involving 35,000 individuals aged 2-16 years in dengue endemic areas. The results of the study that this vaccine is effective in preventing dengue symptoms in individuals aged 9-16 years who had previously suffered from dengue. Individuals who have never been infected with dengue when receiving a vaccine have a higher risk of hospitalization than those who did not get the vaccine (placebo). Sanofi Pasteur in November 2017 then announced that for individuals who had received a vaccine but had never previously suffered from dengue, the individual was at risk of suffering from serious dengue hemorrhagic fever or in other words the vaccine made the case of dengue fever worse in children who had never before infected This caused panic in several countries that had already used the vaccine, including the Philippines, which was the first country where the vaccine was tested. This vaccine is claimed by several parties in the country to be responsible for causing the death of children suffering from severe dengue after receiving the dengue vaccine.

WHO issued a recommendation that if you want to run a dengue vaccination program then every individual who will be vaccinated must have previously carried out an antibody test that claims to be seropositive dengue (or has been infected with dengue) or show laboratory examination documents that confirms having been infected with dengue in the past. If individual screening prevents vaccination is not possible then vaccination can be carried out only if the area has been proven to have a seroprevalence rate of at least 80% in children aged 9 years.

Republic of Indonesia Food and Drug Supervisory Agency in February 2018 in explaining the issue of dengue vaccine security also conveyed the same thing as WHO, namely vaccination can only be done on individuals who have been proven to have suffered from dengue before. The Indonesian National Drug and Food Control Agency also instructed PT. Aventis Pharma to monitor the use of Denvaxia® in Indonesia, especially for individuals / patients who have been identified as getting vaccinations. The Indonesian National Drug and Food Control Agency also requests all components of the health professional's colleagues to prioritize the care and safety of patients in the provision of this vaccine. Until now, dengue vaccine has not been included in the mandatory vaccination policy for children in Indonesia.

With the various recommendations from various health authorities, we can conclude that the dengue vaccine has not been proven to be fully safe for us to apply until there are further research results and recommendations. For this reason, the best effort to prevent dengue fever is to carry out vector control, which is to eradicate Aedes aegypti mosquito breeding sites by making efforts to drain, bury, hoard used goods, and prevent mosquito bites by using mosquito repellent lotion or other mechanical prevention efforts. Take care of your health and the environment. Stay Healthy!

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