HAVANA, Cuba, Dec 18 (ACN) The Regulatory Authority of Drugs, Equipment and Medical Devices of the Republic of Cuba (CECMED) approved on Thursday the beginning of the Phase II clinical trial with Soberana 02, Cuban vaccine candidate against COVID-19.
According to a message spread in the social network Twitter by the Finlay Institute of Vaccines (IFV), the approval of the second phase of Soberana 02 trials comes after registering preliminary positive results of Phase I.
The IFV adds that this step ratifies as Cuban the first vaccine to advance to Phase II in all Latin America.
"The beginning of Phase II clinical trial with the #Soberana02 vaccine is approved, after preliminary positive results from Phase I. Once again, Cuba is the first Latin American vaccine to advance to Phase II. #CubaViva #CubanScience @BioCubaFarma", tweets the Cuban entity.
The IFV's General Director, Vicente Vérez Bencomo, highlighted in the social network that also the vaccine candidate Soberana 01 shows good preliminary results and he predicted the beginning of a second phase of trials for the month of January.
"Towards the desired vaccine! Week 32. SOBERANA 01 does not stay behind. Very good preliminary results augur that it will be in phase 2 in January following the steps of Soberana 02. 'FinlayInstitute', 'Center', 'Synthesis Lab', 'BioCubaFarma', wrote Vérez Bencomo.
At the end of last November, CECMED authorized the beginning of the clinical trials of the candidates against COVID-19, Mambisa and Abdala; with this, the four Cuban vaccine candidates were in phase I of clinical trials, which analysts consider a feat of the biotechnological and pharmaceutical industry of the Caribbean country.
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