According to an article by the Finlay Institute of Vaccines (IFV) in charge of the development of both immunogens, published this Monday in the web repository for unpublished texts on medicine MedRxiv, two doses of Sovereign 02 were safe and reached an efficacy of 71,0 percent in the adult population from 19 to 80 years old.
“The incorporation of Soberana Plus after the previous two, increased that parameter to 92.4 percent,” the text states.
This phase III study was randomized, double-blind, placebo-controlled with some 44,31 volunteer participants from that city.
During the trial, the SARS CoV-2 isolates in Havana were predominantly with the Beta strain (74.0 percent) and gradually changed to the Delta (100 percent), details this Monday’s article in MedRxiv.
In this epidemiological scenario, the authors describe, two doses of Sovereign 02 protect against symptomatic Covid-19 by 71.0 percent, for serious conditions the efficacy was 63.0 and for death 59.0.
When adding the three-dose heterologous regimen with Soberana Plus, this indicator was 100 percent effective in protecting severe cases and death.
“This is the first phase III clinical trial study of a three-dose heterologous vaccine combination against SARS-CoV-2,” the scientists noted.
Previously, in the month of July of this year, the IFV had announced that the preliminary results of this scheme of Soberana 02 plus Soberana Plus in 0-28-56 days, had an efficiency of 91.2 percent.
During the presentation of these data, the Doctor of Science and director of the Finlay Institute, Vicente Vérez, reported that the figure referred to the ability to prevent the symptomatic disease of Covid-19.
He recalled that the result was validated in phase III of the clinical trial carried out in eight municipalities of Havana, precisely when the Beta strain (originally detected in South Africa) was circulating massively in the Cuban capital.