Cuba authorizes clinical trial on children of Abdala vaccine candidate

HAVANA, Cuba, Jul 2 (ACN) The Center for State Control of Medicines, Equipment and Medical Devices (Cecmed) approved on Thursday the Ismaelillo-Pediatrics clinical trial with the anti-COVID-19 vaccine candidate Abdala, scheduled to be carried out in the province of Camagüey.

The Phase I/II sequential, non-placebo study includes 600 volunteers aged three to 18 years, who will receive the three-dose schedule with an interval of 14 days each (zero-14-28).

The research will evaluate two strengths of the product, 25 and 50 micrograms, as the immune system of this population needs less immunogen to generate protective antibodies against the SARS-Cov-2 virus.

In the first stage, adolescents between 18 and 12 years of age will be immunized, and after confirming the safety of the drug - by means of blood tests - it will be administered to children between three and 11 years of age.

In view of the sustained increase of pediatric patients, more than 200 confirmed daily in the last 15 days, Cecmed authorized the start, as from July 5, of the trial with Abdala, a vaccine candidate with an efficacy of 92.28 percent in the prevention of symptomatic disease, according to the results of the clinical study in adults.

The regulatory agency also took into account the evidence of safety and immunogenicity of the formulation, promoted by the Center for Genetic Engineering and Biotechnology (CIGB).

It also indicated that the protocol presented by the scientific institution complies with the ethical requirements and good practices demanded for this type of study, according to international organizations.

Marta Ayala, Director General of the CIGB, explained recently that Dr. Sonia Resik, from the "Pedro Kourí" Institute of Tropical Medicine, will act as principal investigator.

She specified that Camagüey was chosen for the development of this process due to the preparation of its health system in pediatric clinical trials such as that of the anti-polio vaccine and the conditions of its vaccinatories.

The approval of Ismaelillo-Pediatrics coincides with the 35th anniversary of the foundation of the CIGB, on July 1, 1986, by Commander in Chief Fidel Castro Ruz.

In the last 10 days, the entity received two pieces of news that revalidate the scientific and technical level of its personnel: the efficacy of Abdala, ranked among the most effective anti-SARS-Cov-2 drugs in the world, and now the authorization of the clinical trial in children and adolescents.

After this approval, Cuba has two clinical studies for these age groups: Soberana-Pediatrics, from the Finlay Vaccine Institute, and Ismaelillo-Pediatrics from the CIGB.

Cecmed in Cuba guarantees the safety, protection, rights and benefits of the subjects included in any stage of the trial.

It ensures that each site where clinical research is conducted is accredited, in accordance with the Good Clinical Practices and the Clinical Trials Inspection Program, and the regulations and technical standards in force.