The Finlay Vaccine Institute (IFV) announced the start of a clinical study with Quimi-Vio, its vaccine candidate for the prevention of pneumonia, meningitis, otitis and sepsis caused by Streptococcus pneumoniae or pneumococcus, in the capital’s pediatric population with chronic diseases.
Quimi-Vio is a heptavalent conjugate vaccine that protects against the most prevalent serotypes of the bacterium worldwide. It is based on the conjugate vaccine platform, widely used and known for its safety and efficacy in the pediatric population.
According to Dr. Meybi Rodríguez, director of clinical trials of the IFV, told Cubadebate, Quimi-Vio has gone through all phases of clinical evaluation, demonstrating that it is a safe and effective vaccine in the prevention of pneumococcal disease. It began its clinical evaluation phase in children in 2013 and is currently in the final phase of development for the application for registration before the Regulatory Authority, the Center for the Control of Medicines, Equipment and Medical Devices of Cuba (Cecmed).
The specialist pointed out that this vaccine has been developed at the IFV by the same researchers who developed the immunogens Soberana 02 and Soberana Plus for the prevention of covid-19. The clinical development of Quimi-Vio has been financed by the Financial Fund for Science and Innovation (Fonci) of the Ministry of Science, Technology and Environment (Citma). The Fonci is a financial instrument for science, technology and innovation projects, created in 2002.
Last September, a community intervention study was carried out in Cienfuegos, in which 90% of the population between 1-5 years of age was vaccinated. This study is continuity of a similar one carried out in this province between 2017 and 2018, which reached 92% coverage, and allowed evaluating the impact in reducing by more than 62% the rates of hospitalizations due to invasive pneumococcal disease in the Cienfuegos territory, Rodriguez referred.
This week, another clinical study has started in Havana to evaluate the efficacy of the vaccine candidate Quimi-Vio in children between 2-18 years of age, who suffer from chronic childhood diseases. A single dose will be applied in children between 2-18 years of age.
The study was approved by Cecmed and is led by the Provincial Center of Hygiene and Epidemiology of Havana and the Vaccination Program; and conducted by the National Coordinating Center for Clinical Trials (Cecncec).
According to Dr. Mayra Garcia Carmenate, deputy director of the Havana Provincial Center of Hygiene, Epidemiology and Microbiology and coordinator of the trial, this is an opportunity for children suffering from chronic diseases to receive the benefit of a vaccine that has proven to be safe and effective in healthy children.
The Primary Care system is organized and the universe of children who can potentially be included in the study has been identified. Vaccination takes place in 32 polyclinics in all municipalities of Havana.
It is worth noting that pneumococcal disease is a global problem that especially affects children under five years of age. According to the World Health Organization, pneumonia is the single leading cause of infant mortality worldwide. Pneumonia can be caused by viruses, bacteria or fungi, with Streptococcus pneumoniae being the most common cause of bacterial pneumonia in children.
