Dr. Miguel Betancourt Cravioto, Director of Global Solutions at the Carlos Slim Foundation (CSF), presented the Mexican model for ‘Early Planning for the Introduction of Dengue Vaccine in Mexico’ at the 17th International Congress on Infectious Diseases in Hyderabad, India, on March 3, 2016.
CSF in partnership with the Ministry of Health has promoted the design and implementation of this model, which is already a worldwide reference today. The model aims to define criteria and estimate the impact of introducing a new vaccine in the country, through which it will be possible to make public policies recommendations to support decision-making by the responsible government authorities.
Through an anticipatory exercise, it is aimed to close the gap between the appearance of a new vaccine and its incorporation into the national immunization programs of middle and low income countries, exercise that usually takes between 10 and 20 years.
The Mexican model consists of 5 steps:
- Creation of the Mexican Expert Group on Dengue (GMED)
- Discussion of the scientific evidence available
- Estimated impact of the vaccine in the national epidemiology
- Consulting by international experts
- Issuing recommendations to public health authorities
The exercise started in 2013 and consisted of creating the GMED, formed by more than 70 experts from 21 institutions representing the public, academic, social and private sectors, in order to discuss the available evidence on the different vaccines in development and their production.
The discussion focused on six subjects: epidemiological profile and burden of disease, clinical implications, operational and logistical aspects, legal and regulatory aspects, financial and economic aspects, and strategic communication.
The recommendations issued by the GMED in the first round of discussion were published in the prestigious international scientific journal PLOS-NTDs in April 2014.
In August 2015, results of phase 3 clinical trials of the tetravalent dengue vaccine developed by Sanofi-Pasteur were published, the GMED was again summoned to review the new evidence and adjust the recommendations previously issued. To support this second stage, international experts belonging to the Partnership for Dengue Control were invited. They were briefed on the preliminary results of the thematic discussions, and in turn made their suggestions for the introduction of the vaccine.
Simultaneously to the discussion activities, the process to register the vaccine in Mexico started. On December 9, 2015, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) granted the license for use of the vaccine in the Mexico, making the country the first in the world that accepted the use of the vaccine.
Currently, the specialists are completing the final recommendations for the introduction of the vaccine as an important complementary tool against dengue, which will join to the prevention strategies currently implemented at national level.
Mexico and Philippines are the only countries that have participated in all phases of the dengue vaccine development. The vaccine licensing and the anticipatory exercise for its introduction will allow continuing positioning Mexico at the forefront of the early adoption of scientific and technological innovations in health, for the benefit of the population, particularly the most vulnerable.