Information on Dengvaxia®

Information on Dengvaxia® (Dengue Tetravalent Vaccine)

Dengvaxia®, Sanofi’s tetravalent live attenuated vaccine against dengue fever, received its first marketing authorizations in 2015 and is currently approved for use in the US, EU and in some Asian and Latin American countries.1,2,3

In November 2017, Sanofi announced that it was updating its label to restrict the use of Dengvaxia to individuals who had already been exposed to dengue virus.4 Following that update, the World Health Organization recommended limiting the administration of Dengvaxia® to those with past dengue infection (known as ‘Screen & Vaccinate’ [S&V]).3 Following this decision, Dengvaxia’s® value in preventing subsequent, potentially more severe dengue was endorsed by the US Advisory Committee on Immunization Practices (ACIP)5 and in the countries where it is approved for use, specific indications of use vary depending on the population and the risk associated with dengue.

In December 2018, the Philippines FDA decided to revoke Dengvaxia’s Certificates of Product Registration (CPRs). The Philippines FDA’s decision to revoke the license was related to the alleged failure of Sanofi to comply with post-marketing authorization requirements. Their decision was not related to the safety of the vaccine, as confirmed by the Department of Health when they upheld the Philippines FDA decision.  Separately, in February 2019, the Philippines Department of Justice alleged reckless imprudence against both government officials and Sanofi executives. Sanofi rigorously denies these allegations and continues to defend its employees in ongoing court cases in the Philippines.

Dengvaxia® underwent thorough efficacy and safety evaluations and is proven to be efficacious in preventing subsequent, potentially more severe dengue. 6,7,8 Dengvaxia® is available in countries where the product is already distributed, although the ‘Screen & Vaccinate’ requirement means that vaccine uptake remains extremely low.

Dengvaxia® is on the WHO Essential Medicines List and it is registered by EMA, FDA and in some Asian and Latin American countries. It is also a prequalified vaccine by the WHO.9,10,11

As part of its pharmacovigilance obligations, Sanofi continues to update information on its vaccines for both healthcare professionals and patients, in line with developments in scientific knowledge and under the supervision of global Health Authorities.

References 

  1. European Medicines Agency. Dengvaxia Summary of Product Characteristics. Sanofi Pasteur. Last updated August 2023. Available at: https://www.ema.europa.eu/documents/product-information/dengvaxia-epar-product-information_en.pdf Last accessed December 2023.
  2. US Food and Drug Administration. Prescribing Information Dengvaxia. Sanofi Pasteur. Last updated August 2023. Available at: Package Insert - DENGVAXIA (fda.gov)  Last accessed December 2023.
  3. World Health Organization (WHO). Revised SAGE recommendation on use of dengue vaccine. April 2018. WER9323-329-343.pdf (who.int). Last accessed December 2023
  4. Sanofi press release; Sanofi updates information on dengue vaccine
  5. Gailhardou S, Skipetrova A, Dayan G, et al. Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: Pooled analysis of data from 18 clinical trials. PLoS Negl Trop Dis 2016;10(7): e0004821.
  6. Guy B, Noriega F, Ochiai RL, et al. A recombinant live attenuated tetravalent vaccine for the prevention of dengue. Expert Rev Vaccines 2017;16(7):671–83.
  7. Rojas A, Haney O, Khromova A, et al. Three years of post-licensure safety data on a live attenuated tetravalent dengue vaccine (CYD-TDV). Presented at the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), Philadelphia, Pennsylvania. August 24–28 2019.
  8. Gabriela Paz-Bailey et al. Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021. US Advisory Committee on Immunization Practices (ACIP).Recommendations and Reports / December 17, 2021 / 70(6);1–16 Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021 | MMWR (cdc.gov) Last accessed December 2023.
  9. World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Available at: WHO EML 23rd List (2023) Last accessed December 2023.
  10. World Health Organization (WHO). WHO Model List of Essential Medicines for Children. 9th List, 2023. Available at: WHO EMLc 9th List (2023). Last accessed December 2023.
  11. WHO prequalified vaccines, 25 March 2020. Available at: https://extranet.who.int/gavi/PQ_Web/PreviewVaccine.aspx?nav=0&ID=329 Last accessed December 2023.