Quimi-Vio, Cuba's pneumococcal vaccine receives sanitary registration

Havana, Jul 6 (RHC) Cuba's anti-pneumococcal vaccine Quimi-Vio received the sanitary registration from the Caribbean nation's regulatory entity, after a rigorous evaluation process.

After concluding all the required clinical trials, which show sufficient evidence of quality, safety and efficacy, the Center for the Control of Medicines, Equipment and Medical Devices of the Republic of Cuba granted such condition to this injectable product, which is in charge of the Finlay Vaccine Institute (IFV).

The project Quimi-Vio began in 2012 and has had the regulatory accompaniment of Cuban entities.

"It is a very complex vaccine, which, when introduced in the countries that have already used it, has led to a significant improvement in children's health indicators in terms of respiratory disease morbidity and infant mortality due to infections," said Dagmar García, director of Research at the IFV, recently.

The first study with Quimi-Vio was conducted in the central province of Cienfuegos in 2023, "and on that occasion, more than 90 percent of all children between one and five years of age were vaccinated. Approximately 11,600 children participated in the trials, said the specialist.

On the results of those interventions, Garcia said that, in Cienfuegos, in 2018 and 2019, they also conducted a community clinical trial, in which they injected 93 percent of all children between one and five years of age.

"One year after immunizing them, a 63 percent reduction in hospitalization rates for respiratory disease was observed; and a 73 percent reduction in invasive pneumococcal disease, for the serotypes contained in the vaccine," she added.

In June this year, it was announced that an intervention study against pneumococcal disease in infants under one year of age (two, four and 11 months old) will be carried out with Quimi-Vio also in Cienfuegos.

According to the main researcher of the Pedro Kourí Institute of Tropical Medicine (IPK) of the Caribbean nation, María Eugenia Toledo, Quimi-Vio will protect infants under one year old from 11 serotypes that produce pneumocococcal disease. (Source: PL)