Miguel Díaz-Canel Bermúdez, First Secretary of the Central Committee of the Communist Party of Cuba and President of the Republic, headed the meeting of experts and scientists for Health issues at the Palace of the Revolution, which on this occasion had as its theme the «Update of the Pneumococcal Vaccine Project».
Speaking at the meeting, which dealt with the results of the vaccine candidate Quimi-Vio, the President said that they are the prelude to another hard scientific result from Cuba, according to the Presidential website.
The central intervention on the Project was in charge of Doctor in Pharmaceutical Sciences Dagmar García Rivera, Director of Research of the Finlay Vaccine Institute (IFV), who informed about the state of development of the vaccine candidate Quimi-Vio, a conjugated vaccine against pneumococcus that has been under development by the IFV for more than fifteen years.
Dagmar García emphasized that the purpose is to introduce it, at some point, in the national vaccination scheme to protect Cuban children from important childhood diseases in Cuba, mainly in children under five years of age.
During the intervention made among the experts and scientists, an update was given on two clinical trials that took place in September and October; two community clinical trials, phase three, which involved a large number of children.
The first one was carried out in the province of Cienfuegos, started on September 5, and vaccinated 11,600 children, more than 90 percent (%) of all children between one and five years of age.
Cienfuegos is now in the second phase of the study, in which children between one and two years of age who have received two doses are receiving the second dose.
Children over two years old receive only one dose of vaccine, clarified the scientist; who also informed that in the capital a community trial was carried out during October in which, in all municipalities, children between two and eighteen years of age, who suffer from chronic diseases such as heart disease, diabetes, oncological diseases, immunodeficiencies, were vaccinated, since they are the most susceptible to diseases caused by pneumococcus.
Therefore, explained the Doctor of Sciences, this is a study that intends to evaluate over time how vaccination protects healthy children (those vaccinated in Cienfuegos) and children with risk diseases (vaccinated in Havana) from suffering pneumococcal diseases».
On the impact that the future vaccine (still a vaccine candidate) could have on the health system, and particularly on children, Dagmar said that in the province of Cienfuegos, a community clinical trial was carried out in 2018 and 2019, in which 93 percent of all children between one and five years of age were vaccinated.
And one year after vaccination, a sixty-three percent reduction in hospitalization rates due to respiratory disease was observed; and a seventy-three percent reduction in invasive pneumococcal disease, due to the serotypes contained in the vaccine. This demonstrates the positive impact of the vaccine candidate.
This research is ongoing, said the specialist, and she also explained that 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 morbidity of respiratory diseases and infant mortality due to respiratory infections and meningitis.
Regarding the vaccine project, Olga Lidia Jacobo Casanueva, director of the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), said during the meeting that this is an example of vaccine development in the country. It has been a project that has had regulatory support since it began in 2012.
We have reviewed each of the phases of all the clinical trials that Dr. Dagmar has presented; it has been a project that has been followed very closely. The work said the expert, «has been praised even at events we have had the opportunity to attend».
«Today what we can say is that the Project is ready to obtain its sanitary registration,» she announced.
The IFV must submit all the information to the CEDMED, which already has elements that support the safety and efficacy of this vaccine. We are ready to evaluate this dossier, make the corresponding inspection, and have the vaccine in the shortest possible time so that it can be used throughout the country, he declared.