FM highlights participation of over 240,000 Cubans in Soberana 02 and Abdala trials

HAVANA, Cuba, Mar 23 (ACN) Cuban foreign minister, Bruno Rodriguez Parrilla, highlighted today on Twitter that more than 240,000 Cubans are participating as volunteers in Phase III clinical trials of the anti-COVID-19 vaccine candidates Soberana 02 and Abdala.

Scientists, doctors and volunteers working for immunization against COVID-19 are part of a people committed to health and sovereignty, the Cuban diplomat ratified.

After receiving the approval from the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), the anti-COVID-19 Soberana 02 vaccine candidate began its Phase III in early March.

As explained recently by the general director of the Finaly Vaccine Institute, Vicente Verez Bencomo, this is a multicenter, adaptive, parallel-group, randomized, placebo-controlled, double-blind study in 19-80 year-old volunteers with no known history of SARS-CoV-2 coronavirus infection.

CECMED announced on March 18 the approval of the Phase III Clinical Trial of the Abdala vaccine candidate, which is being developed in Santiago de Cuba and Guantanamo provinces between March 22 and April 9.

In order to evaluate the efficacy, safety and immunogenicity of Abdala in the prevention of symptomatic disease due to SARS-CoV-2 infection, 48,000 people between 19 and 80 years of age are expected to participate in a double-blind randomized study, with a control group that will be administered placebo.

Among the 22 vaccines against COVID-19 worldwide in Phase III clinical trials, two are the Cuban Abdala and Soberana 02; the country also has the candidates Soberana 01, Mambisa and Soberana Plus in primary phases of clinical trials.