April 8, 2024
1. It is not recommended that the TAK-003 dengue vaccine be generally included in Mexico's Universal Vaccination Program in accordance with WHO/PAHO recommendations.
2. We agree with the comments and recommendation of PAHO/WHO and more specifically those issued by RITAG-PAHO, on the possibility of introducing TAK-003 vaccine as endemic dengue control, only in specific sub-national geographic areas where there is documented evidence of a "high burden of DENV disease with high historical transmission", provided that careful measures are taken to ensure that the safety and efficacy of the vaccine is evaluated and monitored, and that the communities and health care providers involved are fully informed about the potential benefits and risks.
It is recommended that if this TAK-003 vaccine is introduced as a pilot phase 4 clinical trial strategy for safety and efficacy in cases of confirmed DENV infection, with strong emphasis on surveillance by serotype and genotype of circulating DENV.
4. This should be at an age of 4-16 years in areas of high historical transmission, preferably in those areas where there is previous data of seroprevalence against DENV elevated > 60%. It is emphasized that this data is to improve efficacy and not for safety risk.
5. It is recognized that there are immunogenicity studies (immunopuent studies) and safety studies -but not efficacy studies- for persons aged 17 to 60 years. If these populations are considered to be included, as Argentina is doing, it should also be accompanied by a Phase 4 clinical study of safety and efficacy.
6. Emphasis should be placed on reinforcing arbovirosis surveillance and control programs.
7. The introduction of these specific vaccination groups should be accompanied by a communication campaign directed to health authorities in charge of Public Health at federal, state and municipal levels, to medical personnel and to the population, which should be clear and effective, describing the risks and benefits of this vaccine, the importance of maintaining other public health measures to curb transmission and provide realistic expectations of the impact of the TAK-003 vaccine.
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