The vaccine showed an effectiveness of 92.28% in test phase three, the state-run Centre for the Control of Medicines and Medical Devices (Cecmed) announced at the weekend.
This makes Abdala the first vaccine against the coronavirus to be developed and approved in Latin America.
"A light at the end of the tunnel in this long race against the pandemic," President Miguel Diaz-Canel wrote on Twitter.
It is true that Cuba has a lot of experience in developing vaccines. So far, however, the results of the Abdala study have not been independently verified.
Abdala is a so-called subunit vaccine made from processed proteins of the pathogen. Three doses are administered for full vaccination protection.