A team of specialists from the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) today inspected the trial with the Abdala vaccine and the Mambisa vaccine candidate, which is being carried out at the Hermanos Ameijeiras Surgical Clinical Hospital, in convalescent patients. of COVID-19.
Cecmed, as the Cuban regulatory authority, is responsible for analyzing, approving clinical trials and also inspecting them to find out what happens in real conditions, Doctor of Science Diadelis Remírez Figueredo, head researcher of the inspection group, told the press.
He mentioned that during the meeting they analyzed the work of the Ethics Committee, as well as the clinical laboratory and the calibration of the equipment used, in addition to compliance with good practices in the different services with a view to the certification of the institution.
They also verified the medical records, the information collection notebooks and the inclusion in the database, which is used to process the results and give the final conclusions, hence the importance of analyzing the entire process, he stressed.
The specialist explained that all the trials approved during the pandemic have been inspected by the regulatory authority because they are investigational products, and in the case of this study they carried out a first inspection in July 2021, so it is followed up.
Remírez Figueredo specified that in order to complete the planned sample, it was necessary to make modifications, previously approved by the CECMED, such as the inclusion of other clinical sites in the provinces of Pinar del Río, Camagüey and Santiago de Cuba.
Dr. Iglermys Figueroa García, principal investigator of the trial, explained that phase II is currently close to completion with the inclusion of 1,040 subjects vaccinated with Abdala and Mambisa, and without reporting serious adverse events.
By protocol, it was planned that 928 volunteers would take part, and we reached the figure of 1,040, since more people were included in the group over 60 years of age, so taking into account this sample size, it is likely that it will be closed. inclusion, he pointed out.
The also head of the Allergy Service of the Hermanos Ameijeiras Hospital and a master’s degree in Infectious Diseases said that when this happens, the process of evaluating the results begins to present them to the regulatory authority and that Mambisa can become a vaccine.
The study was designed as a phase I/II clinical trial to evaluate the safety and immunogenicity of the vaccine candidates CIGB-669 (Mambisa) intranasal and CIGB-66 (Abdala) intramuscular, as a booster of immunity in subjects convalescing from the viral disease COVID -19.
