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Cuba's Soberana 02 Vaccine Advances to Phase II Clinical Trials

  • Cuba begins Phase II of its second Covid-19 vaccine candidate, Soberana 02, which should involve about a hundred people.

    Cuba begins Phase II of its second Covid-19 vaccine candidate, Soberana 02, which should involve about a hundred people. | Photo: Twitter @CG_CubaMilano

Published 23 December 2020
Opinion

Cuba's vaccine candidate Soberana 02 began Phase II of Clinical Trials

Cuba's vaccine candidate Soberana 02 began Phase II of Clinical Trials this week, making it the first Latin American vaccine against Covid-19 to advance to this stage following positive preliminary results in the first phase.

RELATED:

Cuba Tests Vaccine Candidate Abdala Against Covid-19

It was approved for Phase II on December 17, receiving authorization from the Finlay Vaccine Institute, which reports that the process has proceeded normally and in strict compliance with the established protocols. 

Soberana 02 is not the only vaccine candidate in Cuba against the SARS-CoV-2 virus. This project has a sister: Soberana 01, which must conclude its Phase I clinical trial before the end of 2020, reports Prensa Latina.

Regarding the progress of the vaccine candidates (Soberana 01, Soberana 02, Abdala and Mambisa), Cuban scientists have reported that Soberana 02 is the more advanced at this point.

General Director of the Finlay Vaccine Institute, Dr. Vicente Vérez Bencomo, has stated that Phase II should involve around 100 people and Phase 2B, between 300 and 600 people (also designed with placebo), while Phase III should include about 150,000 people.

Soberana 02 can be found listed in the Draft of the World Health Organization’s site, a reference for official information on the vaccine’s against COVID-19 which are in clinical trials. Of the 47 candidates registered worldwide, two of them are Cuban. 

"This week, the process of the Phase II Clinical Trial of the #Soberana02 vaccine began. Everything has proceeded normally and in keeping with good practices. Currently, it is being evaluated which of the formulations of #Soberana01 will go to Phase II."
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