Vaccine Info

Cuba Soberana 02 COVID-19 Vaccine

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Last reviewed
June 20, 2021

Cuba Soberana 02 COVID-19 Vaccine Description

Soberana 02 (FINLAY-FR-2) COVID-19 vaccine candidate is a conjugate vaccine in which the virus antigen, the receptor-binding domain (RBD), is chemically bound to the tetanus toxoid.

On August 13, 2020, Cuba's national regulatory agency, the Center for Quality Control of Medicines, Equipment, and Medical Devices, authorized clinical trials for SOBERANA 01, Cuba's first vaccine candidate.

Vicente Verez, Finlay Vaccine Institute, Center for Vaccine Research and Production, is reported by the Agencia Cubana de Noticias news agency to have said, 'The age range of the sample of volunteers in this phase of the test will span from five to 19 years. Vérez Bencomo emphasized that the Institute has vast experience in clinical trials in pediatric ages since previously all its vaccines were intended for this population.'

On January 21, 2021, the BBC reported 'the Cuban government will produce 100 million doses of its vaccine, Soberana 02, against the new coronavirus this year to respond to its own demand and those of other countries. The 100 million doses planned would be only from Soberana 02. Several countries are already interested in acquiring it, such as Vietnam, Iran, and Venezuela, and those with which the island has collaboration agreements, including Pakistan and India.'

On May 8, 2021, the Cuban Minister of Public Health, backed by Article 64 of Law 41 “Public Health Law” of July 13, 1983, approved a health intervention with the Cuban vaccine candidates Abdala and Soberana 02 for groups and risk territories.

Soberana 02 is produced by the Finlay Vaccine Institute (IFV), a Cuban epidemiological research institute, and the Pasteur Institute of Iran, founded in Tehran in the 1920s. The IFV was created in 1991 to expand the achievement of a group of Cuban scientists who investigated, produced, and presented the VA-MENGOC-BC vaccine,

Cuba Soberana 02 COVID-19 Vaccine Indication

Co-produced by Iran and Cuba, the Soberana 02 COVID-19 vaccine candidate is indicated to prevent COVID-19 disease caused by the SARS-Cov-2 virus. According to the WHO candidate landscape vaccine document, this vaccine requires two doses, the second one being administered 14 days after the first vaccination.

Cuba Soberana 02 COVID-19 Vaccine News

June 19, 2021 - Cuba's state-run biopharmaceutical corporation BioCubaFarma confirmed via Twitter the Soberana 2 vaccine candidate has shown 62% efficacy with just two doses.

June 15, 2021 - According to statistics from the Ministry of Public Health, 578,385 Cubans have already been vaccinated with the Abdala or Soberana 2 candidates, which have been administered in risk territory and groups.

June 7, 2021 - Local media reported as part of the clinical trials, intervention studies, and health interventions developed in Cuba, 2,408,135 vaccine doses had already been administered.

June 6, 2021 - Cuba's government website reports 2,882,587 doses administered with Cuban vaccine candidates had accumulated. To date, 1,772,586 people have received at least one dose of one of the Cuban vaccine candidates.

May 30, 2021 - Soberana-02 COVID-19 vaccine jointly developed by Iran and Cuba will complete clinical trials by mid-June 2021, after being administered to 24,000 Iranians. Developed by Cuba's Finlay Vaccine Institute and Pasteur Institute of Iran, the vaccine is a conjugate vaccine with two injectable doses. It consists of the receptor-binding domain of the SARS-CoV-2 spike protein conjugated chemically to tetanus toxoid.

May 28, 2021 - “We decided to start vaccinating people where transmission rates are higher because the risks are also increasing,” Health Minister José Angel Portal Miranda said this week in a video address to the World Health Assembly. “The benefits of this intervention outweigh the risks,” reported the Miami Herald.

May 15, 2021 - CTV News reported Cuban Health Minister Jose Portal said he expects 70% of the population to have received a COVID-19 vaccine by August. By then, BioCubaFarma will have produced enough doses to immunize all of the island’s inhabitants, according to the company’s chief Eduardo Martinez.

May 13, 2021 - Cuba confirmed it had begun a vaccination program without the COVID-19 vaccine full regulatory approval. The Cuban government's Health Minister Jose Angel Portal said between 1.7 million of the 2.1 million inhabitants of Havana, the epicenter of the COVID-19 outbreak, will be vaccinated before August 2021, reported France 24.

May 13, 2021 - Cuba reported on 6,234 patients with COVID-19 admitted to its hospitals, the highest number for a day since the beginning of the pandemic.

May 6, 2021 - Prensa Latina reported Cuba's Soberana Plus vaccine candidate against Covid-19 is currently showing encouraging results by considerably raising antibodies in Covid-19 convalescents with only one dose. In that sense, doctor Maria Eugenia Toledo explained that Soberana Plus places Covid-19 patients in a better situation.

April 29, 2021 - Article published by the journal Nature: Can Cuba beat COVID with its homegrown vaccines? Vicente Vérez Bencomo, director-general of the state-owned Finlay Institute of Vaccines in Havana, where one of Cuba’s most advanced vaccine candidates was created, thinks the chances are good. The candidate, called Soberana 02, entered phase III trials in people in March. It’s one of the country’s two homegrown vaccines — the other is called Abdala — to make it this far.

April 29, 2021 -  Aljazeera reported the Finlay Institute says it can produce 100 million doses of the Soberana 02 vaccine this year. The aim is to satisfy the country’s demand and to be able to export the remaining shots.

April 26, 2021 -  Local media reported Iran a phase 3 study of the Soberana-02 vaccine candidate, jointly developed with Cuba. Manufactured by Cuba's Finlay Vaccine Institute and Pasteur Institute of Iran, the vaccine is a conjugate vaccine with two injectable doses. The receptor-binding domain of the SARS-CoV-2 spike protein conjugated chemically to tetanus toxoid, reported the Islamic Republic of Iran Broadcasting.

April 24, 2021 - The Cuban ambassador to Ukraine, Natacha Diaz, highlighted the development of Covid-19 vaccines in Cuba as part of the advancement of the national biopharmaceutical industry. She explained that the Finlay Vaccine Institute, in cooperation with the Center for Molecular Immunology and the Center for Biopreparations, is developing the vaccine candidates Soberana 01, Soberana 02, and Soberana Plus. Furthermore, according to health institutions, she clarified that open intervention trials are currently being carried out in parallel with Soberana 02 and Abdala, involving around half a million Cubans, more than 70 percent of whom have already received the first dose.

April 18, 2021 - Local media reported the Cuba-Iran Soberana-02 COVID-19 vaccine received a code of ethics to proceed to launch the third phase of the clinical trial in Iran, according to the Ministry of Health. Manufactured by Cuba's Finlay Vaccine Institute and Pasteur Institute of Iran, the vaccine is a conjugate vaccine with two injectable doses. On March 11, some 100,000 doses of the Cuban vaccine were delivered to Iran due to Havana's cooperation program with other countries to develop the vaccine.

April 16, 2021 - The scientific hypothesis of Phase II clinical trial of SoberanaPlus. The scientific hypothesis of this study, supported by the recently completed Phase I clinical trial, is based on the existence of memory B lymphocyte clones in individuals previously infected with SARS-CoV-2, which are selectively stimulated with a dose of the FINLAY-FR-1A vaccine (SOBERANA Plus), thus inducing high levels of neutralizing antibodies, which could protect them against reinfection, in particular against new strains of SARS-CoV-2.

April 13, 2021 - Local media reported Bolivia would express its intention to acquire the Soberana 02 vaccine to Cuba's Government, said Deputy Minister of Foreign Trade and Integration Benjamín Blanco.

April 7, 2021 - Paraguay's Ambassador in Havana Bernardino Cano informed Radio Nacional del Paraguay that they will commercialize Cuban COVID-19 vaccine candidates after sending a report to the foreign minister Euclides Acevedo´s instructions on possible purchase options.

April 1, 2021 - ACN reported the first stage of phase III study of the Cuban vaccine candidate Soberana 02 had concluded. There were 44,010 study participants carried out during 18 days in eight municipalities of Havana. Dr. Toledo Romaní announced that the study continues, considering that it includes schedules of two and three doses: zero, 28 days, and day 56, as the process is structured. Regarding the adverse events reported so far, the doctor reported that no vaccine does not have them, but more than 82% of those reported have been mild. In contrast, serious adverse events have been associated with hospitalizations for positive antigens, Dr. Romani stressed.

April 1, 2021 - As The Lancet Infectious Diseases went to press, Cuba was due to launch a phase 3 trial of its subunit conjugate vaccine against COVID-19. Soberana-2 is one of four candidate COVID-19 vaccines in development in Cuba. The Finlay Institute in Havana produces it. Based on as-yet-unpublished results from early-stage clinical trials, Vicente Verez-Bencomo, director-general of the Finlay Institute, expects the vaccine to show vaccine efficacy in the region of 80–95%. “We are very optimistic,” he said. If everything goes according to plan, Cuba could start a mass vaccination program for its 11.2 million citizens sometime in the summer of 2021.

March 31, 2021 - News article: Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa.

March 25, 2021 - NPR reported Dagmar Garcia Rivera, the research director at the Finlay Vaccine Institute in Havana, announced that one of Cuba's five vaccine candidates, the Soberana 2, appears to be highly effective and is entering the final stage of clinical trials. "This is the first Cuban and Latin American vaccine to advance to phase 3 trials," Garcia declared proudly at a news conference. The phase 3 clinical trial will involve 44,000 people and is the last clinical test before the vaccine is submitted for approval to Cuba's Center for State Control of Medicines, Equipment, and Medical Devices. Eduardo Ojito, the head of the Cuban Center for Molecular Immunology, added, 'the country should have enough doses of Soberana 2 to immunize the whole country by the end of summer.'

March 8, 2021 - SARS-CoV-2 RBD-Tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies. This paper demonstrates that subunit conjugate vaccines can be an alternative for COVID-19, paving the way for other viral conjugate vaccines based on small viral proteins involved in the infection process.

March 4, 2021 - Cuba has started the phase 3 trial of Soberana 02, preparing to vaccinate 44,000 individuals in Havana. Additionally, they expect to immunize the entire Cuban population by the end of 2021.

March 3, 2021 - A non-peer-reviewed preliminary report of an open-label phase 1 clinical trial of a single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents with an excellent safety profile. These researchers concluded by stating: 'The results obtained from this phase I clinical trial demonstrated the safety and immunogenicity of a single dose application of FINLAY-FR-1A to SARS CoV-2 convalescent and paved the way for a phase II clinical trial to establish a general convalescent vaccination protocol.'

February 23, 2021 - CNBC reported, 'Soberana 02 is due to enter Phase 3 trials from March 1, and officials say tests will include as many as 150,000 volunteers within weeks.'

February 17, 2021 - Local media reported the Mexican Foreign Minister, Marcelo Ebrard, said that there is communication on the part of the Ministry of Health with the laboratory in Cuba, which is carrying out the realization and development of this vaccine, so that part of its phase three tests can be carried out in Mexico. Therefore, Soberana 02, one of the four vaccine candidates from Cuba in the fight against the Covid-19 pandemic, could be the subject of trials in Mexico, according to what was reported by that country.

February 16, 2021 - BBC reported, 'Researchers are working long shifts on Cuba's best shot to solve its coronavirus crisis: Soberana 2, the island's domestically-produced Covid-19 vaccine. Soberana (Spanish for "sovereign") 2 is a conjugate vaccine - meaning an antigen is fused to a carrier molecule to bolster the vaccine's stability and effectiveness.'

February 5, 2021 - Cuba will test more than 42,000 people in Phase 3 trials and affirms that it has the capacity to produce 100 million.

February 5, 2021 - Cuba intends to deliver 1 million COVID-19 vaccine doses by April 2021. "Soberana 02 is due to begin the third phase of clinical trials in March, involving some 42,600 participants," said  IFV Director-General Vicente Verez.

January 21, 2021 - BMJ article: Covid 19: Hope is being eclipsed by deep frustration. In the coming weeks, vaccination will be extended to 150,000 people on the island on the way to mass immunization. In addition, a test will be carried out in February to protect children with Soverana 02. The antigen is safe since it does not contain the live virus but its parts, so its placement generates immunity. Still, it does not cause major reactions, and, therefore, it does not require extra refrigeration.

January 12, 2021 - COVID-19 vaccine made in Cuba: when and for whom? While part of the world has already begun to vaccinate, Cuba waits for Soberana 01, Soberana 02, Mambisa, or Abdala. The island's four vaccine candidates against COVID-19 are developed as subunit vaccines, one of the most economical approaches and "the type for which Cuba has the greatest know-how and infrastructure," Riverol told DW.

December 3, 2020 - The BMJ reported, 'Cuba has four vaccine candidates against Covid-19 in clinical trials, after the authorization of the study phase for Mambisa and Abdala, developed by the Center for Genetic Engineering and Biotechnology.' At the beginning of November 2020, the WHO confirmed a COVID-19 vaccine candidate (Soberana 02) was listed on the official site of projects in clinical trials.

November 2, 2020 - Phase-1 of clinical trials with Soberana 02 candidate begins in Cuba. Soberana 02 ended all the research phases required in experimental animals, demonstrating a powerful and effective immune response against the virus, for which the Finlay Institute requested authorization to start Phase 1 clinical trial in healthy adults from the Center for State Control of Medicines, Equipment, and Medical Devices.

Cuba Soberana 02 COVID-19 Vaccine Clinical Trials

Soberana 02 COVID-19 Vaccine has been in human clinical trials since October 30, 2020.