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Cuba: Abdala's Phase III Clinical Trials To Start Monday

  • In this case, Abdala uses the smallest portion of the spike protein, or protein S, which is responsible for the spread of the virus.

    In this case, Abdala uses the smallest portion of the spike protein, or protein S, which is responsible for the spread of the virus. | Photo: Twitter/@cubacecmed

Published 19 March 2021

The vaccine candidate Abdala, from the Center for Genetic Engineering and Biotechnology (CIGB) becomes the second Cuban vaccine candidate against SARS-CoV-2 to pass to phase III clinical trials after the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved the change of stage according to the established regulations.

"Few times in the history of researchers and scientists dedicated to the field of vaccine discovery and development have researchers themselves seen the cycle of a research process close," Dr. Eulogio Pimentel, vice-president of the BioCubaFarma business group, said at a press conference.

"In these weeks, we are living happy moments and peaks. To think that since yesterday we have authorized our second vaccine candidate in phase III clinical trials is something that gives us a lot of energy to continue working," he said.


Cuba's Abdala Vaccine to Begin Phase III Clinical Trials

For the expert, "being about to close a research cycle, in a period of time that does not reach 12 months, is also very gratifying, and above all, it reflects the inventive, technological and industrial capacity of an organization like BioCubaFarma."

"The world woke up today with 22 vaccine candidates in Phase III clinical research, and to those, we should add the 23rd, which is Abdala, a candidate fruit of the efforts of the researchers and technologists of the CIGB and Aica laboratories," Pimentel said.

He specified that the vaccine candidate "Soberana 02 is going according to plan. Good clinical practices in the immunization process are rigorously complied with, and the established number of individuals is included daily. Abdala is starting this stage, and we hope it will develop satisfactorily," he said.

Abdala is a specific vaccine against Sars-CoV-2 "that has been developed by the CIGB, and in collaboration with Aica Laboratories we have managed to turn it into the bulb that we have been able to see today" said Dr. Marta Ayala Ávila, general director of the CIGB.

Regarding the Abdala vaccine candidate's clinical development, the CIGB general director pointed out that following all the requirements demanded by this type of clinical research, following the World Health Organization regulations and the regulatory agency CECMED, the immunogen has undergone rigorous clinical studies.

"The Abdala candidate was placed in its Phase I clinical trial at the Saturnino Lora Hospital in Santiago de Cuba. At that time, 132 individuals were included who have already been vaccinated and their immune response and safety evaluated. This trial began on December 7, 2020, and in February 2021, we started the Phase II clinical trial, which included 660 volunteers, also from the head municipality of Santiago de Cuba," the expert explained.

The Phase III clinical trial we are starting now is an efficacy study, although it also continues to evaluate immunity and immunogenicity. "We also plan to expand vaccination with the stratified Abdala candidate in the near future, starting with risk groups and vulnerable groups, in order to cover the entire population from 19 to 80 years of age," she said.

On the results of Phase I and II trials, the specialist commented that they showed that the vaccine is very safe. "The vaccines based on protein subunits are really very safe. Immunogenicity was also evaluated, that is, the induction of a specific antibody response against the antigen and also that these antibodies are functional, that is, capable of neutralizing the virus, so that it cannot infect human cells."

Likewise, he said, "We completed the vaccination of the 660 individuals in phase II and demonstrated that in all these subjects, the vaccine has been safe and well-tolerated".

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