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The phase III clinical trial developed by Iran's Pasteur Institute with Cuba's COVID-19 vaccines, Soberana 02 and Soberana Plus, showed excellent results, informed today the Finlay Vaccine Institute (IFV).
In charge of the immunogens, the Cuban entity detailed that the double-blind, randomized and placebo-controlled study included 24,000 subjects, to whom the Soberana-02 vaccine was applied in a two-dose regimen in eight cities and a booster dose with the Soberana Plus vaccine in two other cities.
During the analysis, the Delta variant of the SARS-CoV-2 virus, which causes COVID-19, had a 71.9 percent prevalence in July. By August, it was already 95.4 percent, making it widely predominant, the official statement said.
The intermediate analysis showed that the vaccine's efficacy to prevent hospitalization in the two-dose regimen was 76.8 percent and in the three-dose regimen, it was 91.7 percent, the text detailed.
In addition, 87.9 percent of the participants in the two-dose regimen group and 98.8 percent of those in the three-dose regimen group showed a four-fold increase in antibody titers.
To arrive at these results, an independent committee developed the Phase III clinical trial in the Iranian population aged 18 to 80 years, as part of the collaboration between the Pasteur Institute of Iran and the Finlay Vaccine Institute on the Soberana vaccine series.
In this regard, IFV's Research Director, Dagmar Garcia, pointed out in her Twitter account that this trial in the Persian country confirmed the results obtained in Cuba, also facing a predominance of the Delta variant.
Delta prevalence, Iran, Phase-3 clinical trial with Soberana: "The Interim analysis showed the vaccine efficacy in preventing confirmed COVID-19 hospitalization in the three-dose regimen was 91,7% (95% CI 20.7 to 99.1)". Different Country, different colleagues, same Soberana... https://t.co/yZtpfotgje
Last July, both institutions announced the start of the joint manufacture of the Soberana 02 COVID vaccine in Iran, which will be known there as PastuCovac.
Following the announcement of the results of this trial, the director of the Pasteur Institute, Alireza Biglari, indicated that the vaccine boasts unique characteristics, such as having booster doses and also proving useful for ages three to 18 and over 18 too.
"Undoubtedly, the use of this vaccine for the under-18 age group is one of the features that makes students and parents be able to use it safely," the Iranian representative said at a press conference on Saturday.
Iranian authorities approved the emergency use in that country of Soberana 02 since July 1 this year based on the recognition of the results of the pharmaceutical development of the product, the evidence of safety and immunogenicity demonstrated in phase I and II clinical trials carried out in Cuba.