Abdala is a very safe vaccine candidate, says developer

HAVANA, Cuba, May 11(ACN) The certainty that the Abdala vaccine candidate is very safe was ratified on Tuesday afternoon by Dr. Marta Ayala Avila, general director of the Center for Genetic Engineering and Biotechnology (CIGB), in a new working meeting convened by the country's top leadership with experts and scientists who in the course of all these months have contributed directly to the confrontation with the COVID-19.

During the exchange, headed as usual by the First Secretary of the Central Committee of the Communist Party and President of the Republic, Miguel Díaz-Canel Bermúdez, the Director General of the CIGB pointed out that, as part of the evaluation of the results obtained in phases I and II of the clinical trial, it has been possible to conclude that the adverse events are classified between mild (95%) and moderate (5%), on which an active search was carried out during the first 72 hours of application of the doses.

Although it has been necessary to work in an accelerated manner in the development of this type of projects in the country, which normally require several years for their completion, Ayala Avila assured that each step taken has been very rigorous, as well as the clinical evaluation strategy.

Even though one of the characteristics that has distinguished the development of specific vaccines against the new coronavirus has been the overlapping of phases at certain times, "there has been no lack of rigor or compliance with the norms and regulations dictated by the regulatory agencies," he said.

In the course of her explanation, she recalled that the clinical trials with this candidate, for intramuscular application, began their phase I on December 7, with 132 volunteers, a figure that was later increased to 660 in phase II.

In the case of phase III, which began on March 22, the sample to be studied was larger, since 48,290 people were included, who were vaccinated in six weeks, in periods of 0, 14 and 28 days, which required intense work by the participants.

On May 1st -she said- we concluded the administration of the third dose of the last volunteer, and from the 3rd of that same month, a key stage of phase III began, as the 14 days after the last dose began to count, and with it the evaluation of the vaccine candidate's efficacy.

"This is a very important moment in all the development we have achieved so far"; in this stage, details are adjusted, data are accumulated and a rigorous analysis of vital aspects is carried out, she emphasized.

She described as essential the accompaniment that the different phases of the clinical trial have had, both for the implementation of logistic actions and for the monitoring and evaluation of the scientific activities themselves. He emphasized the participation of the medical students in the field search for people who could manifest adverse events, as well as in the data entry process that is currently being carried out.