Dengvaxia: Lancet correspondence “Dengue vaccination: a more balanced approach is needed”


We continue to monitor developments associated with Dengvaxia, recognizing the continuing and troubling political overlay to the issues in the Philippines such as reported in the Business Mirror article below. We did not identify any new press releases or statements on the Sanofi website.
The Lancet
Feb 17, 2018 Volume 391 Number 10121 p631-712
Dengue vaccination: a more balanced approach is needed
Tikki Pang, Duane Gubler, Daniel Yam Thiam Goh, Zulkifli Ismail on behalf of the Asia Dengue Vaccine Advocacy Group
Media reports have cast doubt on the safety of dengue vaccination, resulting in the suspension of school-based immunisation programmes in the Philippines.1 The main concern about the vaccine is the risk of severe disease in children naive to dengue virus. Although these concerns are justified, it is important to consider this risk in the context of the wider population and to consider the public health value of dengue vaccination for the prevention of a disease that affects 400 million people annually, mostly in developing countries.

In most highly endemic countries, where the use of the dengue vaccine is recommended by WHO, 90% of the population are likely to have been infected with dengue virus by adolescence. These seropositive individuals would clearly benefit from receiving the vaccine. In the remaining 10% of the population who remain unexposed to the virus, the risk of severe disease is relatively small (two cases per 1000 individuals). Moreover, individuals who have become ill after receiving the vaccine had a milder form of dengue, which did not lead to shock, bleeding, or mortality, and were successfully treated.2 Nevertheless, in developing countries with weak health systems and high out-of-pocket health-care costs, the need for hospital admission remains a concern.

The vaccine has been shown to reduce severe disease and hospital admissions by 80–90%.3 The cost savings for health-care systems, and economic benefits more broadly, are of considerable importance. For example, it has been estimated that the annual economic burden of dengue in southeast Asia is US$950 million.4

Without trivialising the risk of severe disease in seronegative individuals receiving the vaccine, we propose two approaches to dengue vaccination. First, the vaccine can be used safely in highly endemic areas when introduced in a controlled fashion with enhanced surveillance and risk management. For example, physicians can have informed discussions with parents to highlight the fact that the potential benefits of vaccination far outweigh the potential risks for their child on the basis of factors such as the endemicity level where they live and the age of the individual. Second, a reliable laboratory testing method to detect previous exposure could be discussed and implemented. Newer, more rapid, affordable, and accurate diagnostic tests must be developed.

Although each country needs to make its own decisions regarding the use of the dengue vaccine, the public health value of the vaccine should not be underestimated. With an overall efficacy of 66%, the vaccine would prevent 66,000 new cases in a country in which 100,000 cases of dengue occur annually. Despite the controversy, some countries have decided to continue using the vaccine against dengue.5

The perfect vaccine does not exist and every new product is likely to have safety risks. Although uncertainties exist, the public health and economic benefits of Dengvaxia (Sanofi Pasteur, Lyon, France) far outweigh the potential risks. As the German theologian Meister Eckhart (1260–1328) is credited with saying, “the cost of inaction is far greater than the cost of making a mistake”.

The Asia Dengue Vaccine Advocacy Group is an independent advocacy group of experts, which has received unrestricted educational grants from Sanofi Pasteur. We declare no competing interests.
References available at title link above