Abstract
Cuba's decision in September 2021 to launch a massive vaccination campaign against COVID-19 for children as young as two years old turned heads around the world-of clinicians, immunologists, public health experts, governments and regulatory authorities alike. Since then-and just as pediatric COVID-19 hospitalizations reached record numbers globally-some two million Cuban children and adolescents have received the Cuban Soberana vaccines (1.7 million, or 81.3% of that population through December 16, 2021).[1] Why did Cuban health authorities decide to vaccinate children? What clinical trials provided the evidence for such a course of action, especially for the youngest? And what have been the results thus far? To answer these and other questions, MEDICC Review spoke with Dr Rinaldo Puga, principal investigator for the completed phase 1/2 clinical trials of the Finlay Vaccine Institute's Soberana 02 and Soberana Plus vaccines in pediatric ages. Dr Puga's 30 years as a practicing pediatrician have been accompanied by teaching and research, the latter earning him awards from the Cuban Academy of Sciences, among others. He is currently chief of pediatrics and chair of the Scientific Council at the Cira García Clinic in Havana, which granted him leave to lead the pediatric vaccine trials.
Highlights
Why did Cuban health authorities decide to vaccinate children? What clinical trials provided the evidence for such a course of action, especially for the youngest? And what have been the results far?
To answer these and other questions, MEDICC Review spoke with Dr Rinaldo Puga, principal investigator for the completed phase 1/2 clinical trials of the Finlay Vaccine Institute’s Soberana 02 and Soberana Plus vaccines in pediatric ages
We have had a total of 18 deaths among children and adolescents as a result of COVID-19, associated with other conditions that worsened their prognosis, representing a survival rate of 99.9% in the pediatric age group
Summary
Cuba’s decision in September 2021 to launch a massive vaccination campaign against COVID-19 for children as young as two years old turned heads around the world—of clinicians, immunologists, public health experts, governments and regulatory authorities alike. MEDICC Review: You’ve been the principal investigator for the pediatric clinical trials of Soberana 02 and Soberana Plus, both vaccines approved for emergency use in children and adolescents by Cuba’s regulatory authority. For the phase 1/2 clinical trial in convalescent youngsters, one dose of Soberana Plus was used This was an open, adaptive study and began in Havana on October 5, 2021, with participants at least 8 weeks post-COVID. We already had conditions in place for a heterologous pediatric study involving the Soberanas based on earlier results in adults, which meant we could begin the clinical trials with those vaccines first and these were the first to obtain emergency use authorization for children and adolescents. Rinaldo Puga: Yes, results of the pediatric Soberana clinical trials will be included in the dossier provided to WHO for emergency use listing. COMPLETED CLINICAL TRIALS FOR SOBERANA COVID-19 VACCINES IN THE PEDIATRIC POPULATION (as of January, 2022)
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