Havana, Apr 27.- Researchers from the Cuban Center for Genetic Engineering and Biotechnology (CIGB) are advancing today in the final phase of the design of clinical studies in pediatric populations with the anti-COVID-19 vaccine candidate,Abdala.
At this moment we are in the final phase of designing clinical studies in pediatric populations, Dr. Verena Muzio, director of Clinical Research at CIGB, the leading institution of this vaccine project, recently explained.
Subsequently, they must be subjected to evaluation and authorization by regulatory entities to begin these trials in a not too distant time, said the specialist, adding that studies in pediatric ages are an important element in any vaccine evaluation. Abdala will conclude this week phase III of clinical trials with the administration of the third dose to all volunteers from the Santiago de Cuba, Guantánamo and Granma provinces included in this stage.
At the same time, intervention studies are progressing in risk groups, including health personnel and the BioCubaFarma business group, in various provinces of the country.
The CIGB also develops the anti-COVID-19 candidate Mambisa, the only proposal that is administered intranasally, which concluded phase I of clinical trials in 88 volunteers from Havana.
We are in the final stage of designing and presenting a phase I / II clinical study in convalescent patients with infection by SARS-CoV-2, the virus that causes COVID-19, and about to present it to the regulatory authorities for approval in this capital, said Dr. Muzio.
Soberana 01, Soberana 02 and Soberana PLUS, from the Finlay Vaccine Institute (IFV), are the other proposals of this Caribbean nation to confront the COVID-19 pandemic.
Precisely with Soberana 01 and Soberana 02, immunization in the pediatric population, between five and 18 years old, could soon begin, after requesting authorization from the drug regulatory entity of this country.
According to the IFV researchers, so far these two vaccine proposals have proven safety.
With Soberana 01 the advancement to phase II of clinical studies was requested; while Soberana 02 advances in phase III, with 44 thousand 10 volunteers in eight municipalities of Havana.
With Soberana 02, an intervention study is also underway that includes 150 thousand subjects from population sectors with high risk of infection and spread of the disease, including 74 thousand 665 health workers and the scientific pole.
At the beginning of March, the IFV research director, Dagmar García, assured Prensa Latina that the pediatric population will have the best anti-COVID-19 formulas developed in this country. (Text and photo: PL)