Cuban Vaccine Candidate Abdala to Complete Phase 3 Clinical Trials

The Abdala vaccine candidate against COVID-19, developed by the Center for Genetic Engineering and Biotechnology (CIGB), will complete this week the administration of the third dose to all volunteers as part of phase 3 of clinical trials, an expert announced today in Havana.

Verena Muzio, PhD, director of Clinical Research at the CIGB, said that on May 1, in celebration of International Workers’ Day, they will begin to apply the last doses to all the volunteers included in the trial in the health areas.

In the presentation broadcast by Cuban TV, the scientist informed that on April 19, the last two weeks of administration of the third dose to all volunteers began, of which 21,909 have already been vaccinated as part of this process.

She also recalled that on March 22, the phase 3 clinical research stage with Abdala began in Santiago de Cuba, Guantanamo and Granma with the application of the first dose to 48,290 volunteers during six weeks; while the administration of the second dose concluded on April 17, with 47,620 volunteers, whose results were satisfactory.

Muzio specified that when the vaccination stage of the volunteers is concluded, the follow-up of these people will begin in order to assess the appearance of positive cases of SARS-CoV-2, in these individuals with symptomatic infection.

The expert emphasized that this will make it possible to compare the proportions between the vaccinated group and the placebo group and thus evaluate the effectiveness of the vaccination, the process she announced will begin on May 3.

According to the director of Clinical Research of the CIGB, an institution belonging to the BioCubaFarma business group, 14 days after the person receives his three doses, he begins to be evaluated over time to determine positivity to the virus and clinical symptoms of the disease.

She clarified that information is collected from those who come out positive, and when a number of cases is approximately 50, the first evaluation of efficacy is carried out, to determine the differences between the placebo group and the vaccine group.

This pandemic, which has spread to 190 countries, is becoming more contagious and lethal every day with the circulation of new genetic and mutational variants which make it more difficult to control.

Muzio noted that Abdala is also part of the clinical studies of intervention in risk groups in health personnel and of BioCubaFarma.

Since March 29, Abdala has also been in Havana as part of the clinical intervention study which has included people from health institutions and a group of BioCubaFarma centers that began their vaccination.

The CIGB has plans to evaluate this candidate in pediatric ages and is currently in the final stages of designing clinical studies in this age group.