In the intangible realm, in what we call knowledge, Cuba possesses one of its greatest strengths. Therefore, on Tuesday afternoon, during the traditional meeting of experts and scientists on health issues—held at the Palace of the Revolution—the President of the Republic of Cuba, Miguel Díaz-Canel Bermúdez, stated that, despite the difficult times we are living through, there is good news.
The Head of State made this statement after listening to a group of prestigious scientists who spoke about the progress of clinical trials for new vaccine candidates, which, by their very nature, will have a significant impact on the quality of life of Cubans.
At the event, also presided over by Political Bureau member and Prime Minister Manuel Marrero Cruz, Dagmar García Rivera, Deputy Director of Research and Development at the Finlay Institute of Vaccines (IFV), expressed her gratitude for the opportunity to update the development program for pneumococcal conjugate vaccines, which the Institute has been developing for several years.
The scientist explained that the Streptococcus pneumoniae bacterium "is the leading cause of bacterial infectious diseases in early childhood, in children under five years of age."
She stated that, despite high vaccination coverage rates, millions of people worldwide still die from pneumonia and other diseases caused by this bacterium.
She detailed that the most prevalent diseases are primarily invasive, such as bacteremia, sepsis, and meningitis, as well as mucosal diseases—including otitis media, pneumonia, sinusitis, and conjunctivitis. These illnesses have a greater impact on early childhood, and also on older adults.
García Rivera commented that "there are more than one hundred different serotypes of pneumococcus; of these, between 23 and 25 are the most relevant for causing disease in humans." Therefore, she said, any vaccine approach to prevent the damage caused by the bacteria requires a focus on multivalent vaccines.
HISTORY OF A GREAT VACCINE
The doctor pointed out that, as part of the Pneumococcal Vaccine Program developed by the IFV (Institute of Vaccination and Research), a vaccine was created covering seven serotypes and another covering 11 serotypes—the latter adding four serotypes to the previous seven—and is currently in clinical trials.
She added that there is also a 16-serotype candidate, which adds five more serotypes in terms of epidemiological relevance, and is currently in the preclinical phase, being evaluated in laboratory animals.
The expert explained that researchers estimated the 11-valent vaccine would include not only infants but also older adults, among whom pneumococcal pneumonia has a high incidence.
A previous approach, based on everything learned during the COVID-19 pandemic, and knowing that the 11-valent vaccine uses the same technology as the seven-valent vaccine, led to the decision to take the candidate—because safety conditions were also met—directly to phases 2-3 of clinical trials, without needing to go through phase one, García Rivera reflected.
She added that these steps were approved by Cedmed (Center for State Control of Medicines, Equipment and Medical Devices). That was the prelude—the expert recalled—that paved the way for the clinical trials.
THE CLINICAL TRIAL
The Director General of the Finlay Institute (IFV), Yury Valdés Balbín, stated at the meeting that “the pentavalent vaccine has five components. And here we are talking about a vaccine with 11 components.”
“There is growth in the Cuban vaccine industry that is not limited to the Finlay Institute. And that growth is a consequence of this project,” he noted.
Doing everything within the primary healthcare system, he commented, “presents a very significant challenge. And with two-month-old infants, only a political system like ours has the capacity to coordinate all the stakeholders.”
“We are talking about a trial, like all the trials we conduct, in primary healthcare. This is not done in hospitals; it is one of the most advanced techniques available,” the expert emphasized.
The scientist acknowledged the efforts of those working in the municipalities, in the neighborhoods, in places like Havana, Cienfuegos, and Santiago de Cuba.
"One life we have saved," he said, "is enough to justify all the effort we have made. That is what the Revolution has taught us. And I believe that needs to be said."
THE FIGURES SPEAK FOR THEMSELVES
María Eugenia Toledo Romaní, the project leader, emphasized that the research "has been responsible for accumulating the necessary evidence to demonstrate the impact on populations."
She explained that "between 2017 and 2019, a vaccination campaign was conducted, in which we vaccinated all children in Cienfuegos province, between the ages of one and five, with a coverage rate exceeding 90%. If we use the indicator of invasive disease, which is what kills our children—related, above all, to meningitis—we must say that the rates ranged between 3.1 and 9.1 per 10,000 children in that age group."
“After implementing the vaccination program among children, starting in 2019—and note that COVID-19 was in the middle of that—the incidence rates in children between one and four years old dropped to zero, and in all age groups they remained at around 1%. All the children who became ill after 2019 in Cienfuegos were unvaccinated.”
The expert explained that pneumococcal disease also produces high rates of hospitalization for severe pneumonia in our intensive care units: “And look, today we have data from the monitoring by this sentinel surveillance network and the very important work of the IPK reference laboratory: The rate of severe pneumonia among vaccinated children admitted to intensive care units in Cienfuegos is 3.14. But do you know what the rate is for unvaccinated children? 123.67.” Therefore, each unvaccinated child has a 3.48 times greater risk of being admitted to intensive care.
For his part, the President of Finlay Vaccines S.A., Vicente Vérez Bencomo, commented that “we cannot be satisfied even with this 16-serotype vaccine, which seems like a technological marvel. To go beyond 16 serotypes, we have to make technological leaps."
The executive returned to a concept from the era of Fidel Castro, one that has always guided Cuban science: “We have to compete with the best.”
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