The Ministry of Health began this week the application of Cuban vaccines: Soberana 02 and Abdala, in children and adolescents. The application of these vaccines, which have not completed their study phases to be applied to minors, indicates that the pediatric population of Nicaragua is being used to evaluate them.
“We do not have confirmed efficacy and safety data (of these vaccines) and in fact to vaccinate your children would be to involve them in the research phases of this vaccine ”, explains a specialist doctor, who asked not to include his name for fear of reprisals.
Likewise, it details that “all Cuban vaccines are currently undergoing phase III research studies (massive application) to confirm their safety and efficacy by comparing them against placebo. The analysis of the results of these phase 3 studies will not be ready until January 2022 ”.
The Nicaraguan Exile Medical Association (AMEN) agrees with this doctor’s opinion; as alerted this week, offering these vaccines to children “becomes an experiment that violates bioethical norms, since parents are not told that these vaccines are still in the experimental stage “, they denounce.
According to official information, Until noon this Friday, the Minsa had already applied 261 102 doses of the Sovereign 02 vaccine, in children between 2 and 11 years old, and 178 762 doses of Abdala in adolescents between 12 and 17 years old.
Unlike the Spuntik Light vaccine, which has caused controversy in Nicaragua – which has not concluded its third phase of study either and is not approved by the World Health Organization (WHO) – this is not a new vaccine like the Cuban ones , as it is the first component of Sputnik V, which has already been applied massively and studies have been carried out to evaluate its efficacy against the variants.
Creator of Cuban vaccines confirms initial phases
The Finlay Vaccine Institute (IFV), creator of the Soberana 02 and Soberana Plus vaccines, who in the presentation of the results of his “SOBERANA-PEDIATRÍA Clinical Trial”, published in September the results of the first two study phases in children. In these it is evidenced that the child population that has already received these doses is minimal, although they showed positive results.
The publication indicates that in their early phases these vaccines were “well tolerated after the administration of two doses in children and adolescents aged 3-18 years of Phases I / II”. Likewise, they indicate that there were no serious or severe adverse events consistent with vaccination. However, as the studies are in their early stages, the number of minors that were included is small.
“We do not have confirmed efficacy and safety data (of these vaccines) and in fact vaccinating your children would be to involve them in the research phases of this vaccine, and it is worrying that the evaluation in practice is being carried out under the modality of “intervention studies”, without the strict control and measurement of adverse reactions required by randomized double-blind, placebo-controlled 50/50 clinical trials. they had been planned ”, explains the doctor.
The vaccination day for minors in Nicaragua began this Monday and according to official data, As of noon this Thursday, 218,393 doses of the Sovereign 02 vaccine had already been applied in children between 2 and 11 years old, and 152,256 doses of Abdala in adolescents between 12 and 17 years old.
Phase III requires application in large populations
For a vaccine to have the green light to be applied in the population, it must complete three phases. In the first two, the aim is to evaluate the safety, immunological capacity, the doses that are needed and the method of administration of the vaccine. These studies are carried out in small groups, of less than 100 in their first phase and between 200 and 500 in their second phase.
In the third phase, the vaccine must be applied to a larger number of people, to evaluate the safety and efficacy of the vaccine, explains the World Health Organization (WHO).
According to the information published by the Finlay Vaccine Institute (IFV), last June the phase I and II clinical trial began in the pediatric population of Cuba.. The trial was developed at the Pediatric Hospital Juan Manuel Marquez, the polyclinic Carlos J. Finlay, of the Marianao municipality and the polyclinic September 5, of the Playa municipality, in the province of Havana.
“The 350 children included in the trial have received the two doses of Soberana 02. All the children in the subgroup of 12 to 18 years have already received the booster dose with SOBERANA-Plus, as well as those of 3-11 of phase I” , they assure.
In the case of Abdala, developed by the Center for Genetic Engineering and Biotechnology (CIGB) of Cuba, it reported that Until the beginning of August, this vaccine was in phase II of the pediatric clinical trial and had been applied to 300 adolescents in that country.
According to the principal investigator of the clinical trial, Sonia Resik Aguirre, “the results of the Phase I-II pediatric clinical trial, under the name of Ismaelillo, must be ready between the months of September and October, and If everything is favorable, as expected, then the Abdala vaccine will be available for application to the entire child population of Cuba ”. This vaccine, which has not finished its phase III, was approved this week in Cuba to be applied in children and adolescents.
The other vaccines that have completed studies on the effects in children and adolescents are Moderna and Pfizer, these have already completed their Phase III studies. However, none of these seeks to apply to children under 5 years of age, as the Cuban does. According to the studies presented, in the case of Moderna, phase III included 4,753 children between the ages of 6 and 11 who received the vaccine or a placebo. Meanwhile, the Pfizer study included 2,268 participants ages 5 to 11.
Phase III adult vaccines is not public
Cuban vaccines in people over 18 years of age have already concluded phase III studies. However, these have not been published in scientific journals. and consequently it has prevented the data from which the results were obtained from being known, this is important so that external specialists can verify if there are errors.
“Cuban researchers have not given details or figures but have reported in press releases that the levels of neutralizing antibodies induced by Abdala are similar or slightly higher than those present in convalescent serum (the standard with which all researchers usually compare their vaccine results) ”, says the Nicaraguan doctor.
It also adds that “The worrying thing is that the validation trials (phase 3) are being run in Iran and Venezuela in> 100,000 volunteers with Sovereign 02, (countries with dark data), while in Cuba the same vaccine is being tested in> 150,000 volunteers and Abdala in> 120,000 volunteers and this vaccine is not being evaluated under the strict double-blind, placebo-controlled trial format, but as a less strict intervention study at the time to evaluate its effectiveness ”, says the doctor.
The Government of Daniel Ortega approved the emergency use of these vaccines on October 2. Days later, he announced that a total of seven million doses of these vaccines would arrive between the middle of this month and the end of December. He did not explain if this is a direct purchase from Cuba and neither did they mention that these vaccines are still in the study phase. The only requirement is that parents of children under 17 must sign their authorization before applying the doses.
