EMA Announces Positive Indication for Takeda’s Dengue Vaccine

The European Medicines Agency (EMA) human medicines committee (CHMP) announced a positive indication for Takeda’s dengue tetravalent vaccine (live, attenuated) on Oct. 14, 2022. The vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

Dengue is a mosquito-borne tropical disease caused by four types of the dengue virus, typically resulting in mild flu-like symptoms. However, severe disease can also occur, resulting in potentially fatal bleeding and organ damage, particularly in individuals who have been infected a second time. According to the World Health Organization, the disease is currently endemic in more than 100 countries (including in Europe) and is estimated to have 390 million infections and result in 20,000 to 25,000 deaths per year, primarily in children (1).

According to an EMA press release, antiviral therapies for the infection are not currently available; most current measures rely on mosquito control. While an approved vaccine does exist, the agency stated that the tetravalent vaccine addressed a global unmet public health need because it demonstrated wider protection for young children and people older than 45 years old. Across 19 clinical trials of more than 27,000 individuals, the vaccine was found to reduce fever, severe disease, and hospitalization from any of the virus’ four serotypes.

The CHMP reviewed this product under the “EU-Medicines for all” program, which is meant to support parallel applications in Europe and the rest of the world. According to the release, this centralized procedure is meant to accelerate the adoption of innovative or generic medicines and vaccines while avoiding duplication of efforts from regulators.

Source: European Medicines Agency

Reference

1. World Health Organization, “Dengue and Severe Dengue,” Press Release, Jan. 10, 2022.