The immunizer developed by the Finlay Vaccine Institute "has shown an adequate safety profile, and it has passed all the review done by the regulatory entity during Phase I and II of studies," CECMED President Olga Jacobo said.
To allow the vaccine's mass use in a new phase of studies, CECMED reviewed the test results in animals and volunteers. It also evaluated the product's and the production processes' quality.
"People who have taken part in trials have developed neutralizing antibodies, which means the vaccine is effective against the virus," Jacobo added.
The Health Ministry reported that the third phase of clinical trials will be carried out in 50 vaccination centers distributed in eight municipalities in La Habana.
"The positive results of the vaccine give us hope. However, we must go step by step. We need to be patient and comply with the established regulations," she added and informed that 40,010 volunteers will take part in the new phase.
Soberana 02 is a safe antigen that does not contain the live virus but parts of it extracted from mammalian cells. On December 22, it started its phase 2 clinical trials, becoming the first Latin American COVID-19 vaccine to reach this stage of studies.
Cuban scientists are also developing Soberana 01, Soberana 01-A, Abdala, and Mambisa vaccines.