Soberana 02 or Soberana 2, technical name FINLAY-FR-2, is a COVID-19 vaccine produced by the Finlay Institute, a Cuban epidemiological research institute. The vaccine is known as PastoCovac (Persian: پاستوکووک) in Iran, where it has been developed in collaboration with the Pasteur Institute of Iran. It is a conjugate vaccine that requires two doses, the second one being administered 28 days after the first shot. A third (booster) dose of Soberana Plus may also be given on day 56. It has received emergency use authorization in Iran in June 2021, and in Cuba in August 2021, where it has also been approved for children above 2 years old. The name of the vaccine, Soberana, is a Spanish word that means "sovereign". It followed a previous candidate vaccine called SOBERANA-01 (FINLAY-FR-1).
Medical uses The vaccine requires two doses, the second one being administered four weeks after the first shot. A third (boost) dose of Soberana Plus may also be given on eight weeks.
Efficacy The interim results of a Phase III trial in Cuba has shown an efficacy of 71.1% after only two doses, increasing to 92.4% after adding a dose of Soberana Plus. The trial was undertaken while the delta variant was gradually taking over from beta in Havana. The interim results of the Phase III trial in Iran show that the efficacy of a two-dose regimen is 51.31% against symptomatic disease, 78.35% against severe disease, and 76.78% against hospitalization. A third dose of Soberana Plus increases the efficacy against symptomatic disease to 70.58%, 83.52% against severe disease, and 91.76% against hospitalization. 89% of the cases in the Iranian trial were identified as having the delta strain. The final results of the Phase III trials in Cuba show an efficacy against symptomatic disease of 71.0% against the beta and delta strains, while a third dose of Soberana Plus increased the efficacy up to 92.4%. Efficacy against severe disease and death is 100% for the heterologous three-dose regimen. The final results of the Phase III trial in Iran show an efficacy of 67% against symptomatic disease and 96.5% against severe disease and hospitalization for a heterologous three-dose regimen. No deaths were observed in the trial group that received the three-dose regimen. Unlike the Phase III trials in Cuba, the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation). A 2021 multicentre, randomised, double-blind, placebo-controlled, phase III trial of Soberana 02 showed acceptable vaccine efficacy against symptomatic COVID-19 and COVID-19–related severe infections. The trial was conducted in Iran and, for a 2-dose treatment, showed an efficacy of 49.7% against symptomatic disease, 76.8% against severe disease and 77.7% against hospitalisation. When a third dose of Soberana Plus was added to the treatment, the efficacy improved to 64.9% for prevention of symptomatic disease, 96.6% for prevention of severe disease, and 96.6% for prevention of hospitalisation.
Pharmacology FINLAY-FR-2 is a conjugate vaccine. It consists of the receptor binding domain of the SARS-CoV-2 spike protein conjugated chemically to tetanus toxoid. Professor Ihosvany Castellanos Santos said that the antigen is safe because it contains parts instead of the whole live virus, and therefore it does not require extra refrigeration, like other candidates in the world.
Manufacturing The spike protein subunit is produced in Chinese hamster ovary cell culture. In the ACS Chemical Biology article, scientists from Cuba explain details of the vaccines technology and production.
Production Cuba Iran (under name of PasteurCoVac) Potential Production Ghana Argentina
In Cuba The Cuban government says it is planning to produce 100 million doses of its vaccine to respond to its own demand and that of other countries. Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country. The production of the first batch of about 100,000 doses will start in April. José Moya, representative of the World Health Organization and the Pan American Health Organization (PAHO) in Cuba, suggested that after the vaccine passes all clinical stages, it could be included as part of PAHO's Revolving Fund. The roll-out began with an "Interventional Trial" that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers. On April 11, 2021, the Ministry of Public Health of Cuba announced that 75,000 health-care workers were inoculated with their first dose of either of the two Cuba's Phase III vaccines (the other being Abdala). By April 2022, Cuba inoculated 9.9 million of its 11.2 million residents, 6.4 million have received booster doses. The vaccine campaign using domestic products was heralded as a huge success by Cuban President Miguel Diaz-Canel when case loads were down significantly since January 2022. The Soberana vaccine preparations were particularly effective in children, preventing 70,000 pediatric cases before the Omicron wave hit.
Outside Cuba Vietnam, Iran, Venezuela, Argentina, Pakistan, India, the African Union, Jamaica, and Suriname have expressed interest in purchasing the vaccine, following Phase 3 results. Iran has signed an agreement to manufacture the vaccine and Argentina is negotiating one. Additionally, the Cuban government offered a "transfer of technology" to Ghana and will also supply "active materials" needed to make the vaccine. While the price is currently unknown, the commercialization strategy of the vaccine will be a combination of the "impact on health" and the capability of Cuba's system to financially support "the production of vaccines and drugs for the country", per the director of the Finlay Institute, Vicente Vérez. Up to 27 November 2021, 8 millions doses of Pasteurcovac have been produced in Iran.
Clinical trials
Phase I FINLAY-FR-2, which started being developed in October 2020, had 40 volunteers for its Phase I, according to the Cuban Public Registry of Clinical Trials, with an open, sequential and adaptive study to assess safety, reactogenicity and explore immunogenicity of the vaccine.
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