The mere fact of being able to tell Cuban families that a new, effective and safe Cuban pneumococcal vaccine will soon be available, work on which has been advancing since 2006, is already more than just “good news.”
It’s a comforting thought, “after so many years of development of this vaccine candidate, which includes seven serotypes in a single vaccine and, therefore, it is as if we were developing seven vaccines in one. This singularity has made preclinical demonstrations, the pharmaceutical development and clinical demonstration more complex,” Darielys Santana Mederos, biochemistry graduate and general coordinator of the Finlay Institute’s pneumococcal project, told Granma at the recently concluded Cuban Pediatrics Congress, Pediatría 2018.
According to the expert, following the introduction in the country of vaccines against Haemophilus influenzae and meningococci, pneumococcus is now the fundamental pathogen to cause pneumonia and bacterial meningitis in Cuban children. “Therefore, prevention with a vaccine against pneumococci would have a significant impact on reducing the incidence of bacterial pneumonia and meningitis in this population,” she added.
Although there are two commercially available vaccines of this type in the world, their prices are restrictive for Cuba. “Each child must be immunized with at least three doses according to what is scientifically proven today,” Santana explained, noting, “Each dose, at the pharmacy price, is around 50 dollars, and Cuba would have to spend an excessively high amount.”
Therefore, she said, we had to devise a development strategy for our own candidate, in order to protect our children against the bacteria.
The Finlay Institute has done just that. Under the trademark Quimi-Vio, the heptavalent vaccine will reach all Cuban provinces by next year.
“We have already conducted clinical studies in adults, in children between four and five years of age, in children between one and five years of age, in infants aged seven to 11 months; and at this time we are working with infants up to six months, which is the final target population,” the specialist reported.
Santana noted that the demonstration of clinical evidence should conclude this year. However, she stressed that “to introduce a vaccine, not only must the clinical demonstration stage be overcome; we must also have the productive capacities ready, and we will not have them this year. We are anticipating that by 2019 we will be able to present the application for registration of the immunogen for pre-school children aged between one and five years.”
In this regard, she mentioned that the vaccine will be first introduced in this sector of the population, because the clinical demonstration period for younger children is longer, in addition to the fact that the highest incidence of pneumococcal diseases in our country is concentrated precisely in this age group, rather than in infants.
Regarding the clinical trials in minors, the general coordinator of the Finlay Institute’s pneumococcal project highlighted that more than 5,000 Cuban children have already been vaccinated, which has shown that the product is safe, with no serious side effects, apart from those related to any vaccination: redness in the arm and a low-grade fever.
She also commented that a community intervention study with this heptavalent vaccine candidate is underway in Cienfuegos, which means measuring the effectiveness and safety of the vaccine in more extended environments, such as the application of the vaccine to approximately 22,000 children of this province.
All these studies have enjoyed the collaboration of the Ministry of Public Health, the Maternal-Infant Care Program, the Immunization Program, and others; and have been registered and authorized by the national regulatory authority, the Center for State Control of Medicines, Medical Equipment and Devices (CECMED).
VAC-CUBA: A KEY STRATEGY
A round table was held as part of the Pediatría 2018 Congress, recently held in Havana’s International Conference Center, on the research and development of new vaccines for Cuban children, and the perspective of the Finlay Institute.
Isabel Pilar Luis González, epidemiologist of the Finlay Institute’s Clinical Research and Surveillance Directorate, noted that as part of its mission to provide the necessary immunogens for the prevention of communicable and vaccine-preventable diseases, the institution is currently developing several vaccine candidates.
“There is a strategy to complete in the medium term - after these seven serotypes - 13 more that could provide protection to the Cuban population against approximately 20 pneumococcal serotypes. This process first includes this heptavalent vaccine, which could become a combined vaccine for more serotypes, and then a vaccine against emergencies,” she explained.
However, according to Luis González, in order to present all the evidence to demonstrate the efficacy, effectiveness and the subsequent impact of the introduction of this immunogen in Cuba, the Finlay Institute - in collaboration with the Ministry of Public Health and the national health system, several hospitals, the National School of Public Health, the Pedro Kouri Institute of Tropical Medicine with its national reference laboratories, the University of Havana and other institutions depending on the need for studies - has promoted and developed a platform based on networking, called the VacCuba Network.
She explained that the network consists of a set of institutions that, as nodes, contribute their experience in conducting social, clinical, surveillance and epidemiological studies, as well as economic studies that include cost-effectiveness, cost-utility; in order to demonstrate not only the efficacy and safety of the vaccination, but also to be able to provide evidence to the national health system and decision makers on these aspects, and the advantages of introducing the product.
“In the case of the pneumococcal vaccine, which constitutes the primary experience as regards the creation of this network, we can say that we have achieved a working group in which, in addition to the centers previously referred to, specialists from three provinces of the country are involved: Havana, Cienfuegos and Santiago de Cuba. Specifically, we work with the Juan Manuel Márquez, Wiliam Soler, and Centro Habana pediatric hospitals, while in Cienfuegos, with the Paquito González hospital, and in Santiago de Cuba with the Norte and Sur hospitals,” explained the epidemiologist.
She added that in these institutions, a strategy to monitor syndromes of pneumonia, meningitis and other conditions is currently being developed.
“Thanks to the research advantages offered by the VacCuba Network, today we know about the distribution of pneumococci in these provinces that in some way represent Cuba, and which are not exactly the same as those circulating in other parts of the world. For example serotypes one and five, which were included in the initial pneumococcal vaccines, in Cuba do not seem to be as well represented. However, there are other genotypes - those that we are considering adding to the new generations of vaccines - that we have realized are represented in Cuba, and that in other countries may not be a problem, or do not have the same prevalence.”
This same integrated clinical research strategy is the working platform that the Finlay Institute advocates in the study of all its products. New projects already include VacCuba as a guarantee to start, for example, in conjunction with the national health system and its units, the burden studies of transmissible diseases such as rotavirus, explained Sc.D. Nevis Amin, of the institution’s projects and products management.
“Achieving a new update of the vaccine against Bordetella pertussis (whooping cough) that can make an impact not only on young children, which is what we have today, but also have an impact on the disease and the carrier state; and that then permits its introduction as a less reactogenic vaccine than the current one, in other age groups, is another of the Finlay Institute’s current lines of work,” the specialist stressed.
- Pneumococcal diseases include pneumonia, meningitis and febrile bacteremia, as well as otitis media, sinusitis and bronchitis.
- By the end of 2016, pneumococcal vaccine had been introduced in 134 countries (only partially in three of these), and the estimated global coverage was 42%.
- Cuba has immunization coverage of over 98% with 11 vaccines that protect against 13 diseases.
Sources: WHO & Minsap