Cuban scientists prepare new anti-COVID-19 studies in the country

HAVANA, Cuba, May 10 (ACN) The Center for Genetic Engineering and Biotechnology (CIGB by its Spanish acronym) and the Finlay Vaccine Institute (IFV), promoters of the anti-COVID-19 Abdala and Soberana vaccines, respectively, are preparing new clinical trials to protect under two-year-olds from the disease.

Verena Muzio, director of Clinical Research of the CIGB, informed today about the Espirta study, with more than 900 women from Havana and their babies included, to determine the immunogenicity and safety of Abdala in this vulnerable group, which was vaccinated last July with this drug.

The scientist pointed out that they are looking for details of how gestation, delivery, puerperium and what happens in children, in terms of passive transfer of immunity, through the placenta and then with breastfeeding during the first six months of life.

She also referred to the Pequeñuelo trial with six to 11-month-old infants to evaluate the same variables and another immunopuent, in accordance with the recommendations of international agencies for these types of research and to apply the efficacy previously obtained.

For her part, Dagmar Garcia, IFV Research Director, commented on the design of Soberana Chiquitines in the province of Cienfuegos(central Cuba), in which two doses of Soberana 02 and one of Soberana Plus will be administered, based on the evidence of safety, immunogenicity and efficacy gathered during the clinical trial in the pediatric population.

Garcia, who is also a PhD in Pharmaceutical Sciences, mentioned the phase I/II Soberana Futuro study for 7 to 11 months old children, which will evaluate safety and immunogenicity at each stage, respectively, with more time between the application of one dose and the other, because it is vital to allow time for the maturation of the immune response.

Both scientists clarified that these studies are awaiting the approval of the Center for State Control of Medicines, Equipment and Medical Devices, as the regulatory authority, but the impact of the immunization strategy implemented in Cuba, which contributed to the control of the pandemic, shows the right path.