Cuba Soberana COVID-19 Vaccine Description
Soberana 02 (FINLAY-FR-2) COVID-19 vaccine is a conjugate vaccine in which the virus antigen, the receptor-binding domain (RBD), is chemically bound to the tetanus toxoid.
The technological platform used in the Soberana 02 vaccine is the same method developed and used to produce the active principle of the Cuban conjugate Quimi-Hib® vaccine, which has demonstrated its safety and efficacy in the lactating population and has been incorporated into the National Program of Vaccination since 2004. Conjugated polysaccharide vaccines, such as Soberana02, generate a long-lasting and protective immune response in the general population, particularly in those under two years of age, an age group in which unconjugated polysaccharide vaccines have little or no effect.
Dr. C. Vicente Vérez, General Director of the Finlay Vaccine Institute, marked the industrial production of the first 150 thousand doses of the Soberana 02 vaccine on February 8, 2021.
On August 13, 2020, Cuba's national regulatory agency, the Center for Quality Control of Medicines, Equipment, and Medical Devices (CECMED) authorized clinical trials for SOBERANA 01, Cuba's first vaccine candidate.
A non-peer-reviewed study was published on March 3, 2021: 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. A preliminary report of an open-label phase 1 clinical trial. This short report shows a) an excellent safety profile one month after vaccination for all participants, similar to that previously found during vaccination of naïve individuals; b) a single dose of vaccine induces a >20 fold increase in antibody response one week after vaccination and remarkably 4-fold higher virus neutralization compared to the median obtained for Cuban convalescent serum panel.
As of August 22, 2021, about 10 million Cubans (90% of the population) had received at least their first dose of Soberana 02 or Abdala. A study reported by a peer-reviewed journal found after the three-dose cycle, Soberana 02 is 91.2% effective after two doses when followed by a booster of Soberana Plus. Cuban health authorities have committed to vaccinating the entire population, including children aged 3-18 years old, using these vaccines by the end of 2021.
The Lancet published a study on September 15, 2021: A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial. A single dose of the FINLAY-FR-1A vaccine against SARS-CoV-2 was an efficient booster of pre-existing natural immunity, with an excellent safety profile. FINLAY-FR-1A is a vaccine based on recombinant d-RBD on aluminum hydroxide gel. It is being studied for the protection of naïve individuals, COVID-19 convalescent subjects, and its use as a booster for persons already immunized with other vaccines is being considered.
The Finlay Vaccine Institute (IFV), a Cuban epidemiological research institute, officially announced on June 19, 2021, that SOBERANA 02, developed together with the Center for Molecular Immunology and the University of Havana, had shown the first efficacy data clinic against symptomatic disease COVID-19 in a schedule of two doses every 28 days.
On October 11, 2021, the results of a phase III clinical trial developed by the Pasteur Institute of Iran confirmed the efficacy of the SOBERANA-02 and SOBERANA Plus vaccines against the SARS-CoV-2 Delta strain. Then, on November 1, 2021, a late-stage study reported SOBERANA Plus after two doses of SOBERANA 02, increased efficacy from 71.0 % to 92.4%
Instituto Finlay de Vacunas Cuba: FINLAY-FR-2 clinical trial listing and SOBERANA PLUS information.
Soberana is produced by the Finlay Vaccine Institute, located at Avenue No. 21, No. 19810, Reparto Atabey, Playa, Havan, 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,
Soberana COVID-19 Vaccine Indication
According to the WHO, this vaccine requires two doses, the second one being administered 14 days after the first vaccination.
Soberana COVID-19 Vaccine Dosage
Three doses of the Soberana 02 is more than 90% effective in protecting against symptomatic COVID-19 infection. A third dose, of SOBERANA Plus (RBD-dimer), further increased the specific anti-RBD neutralizing antibodies.
Soberana COVID-19 Vaccine News
December 2, 2021 - The director of Cuba’s Finlay Institute for Vaccines stated Soberana-02 vaccine would continue to provide “a certain level of protection” against Omicron, but added the extent of that protection was still uncertain.
November 22, 2021 - The journal Nature published: Cuba’s bet on home-grown COVID vaccines is paying off. Preprint data show that a three-dose combo of the Soberana vaccine has 92.4% efficacy in clinical trials.
November 13, 2021 - The AP reported Venezuela’s government confirmed that children under 12 will be vaccinated with the Soberana vaccine developed in Cuba.
November 6, 2021 - A non-peer-reviewed study reported a phase-3 study of a three-dose, heterologous COVID-19 vaccine. Two doses of SOBERANA 02 were safe and attained efficacy of 71.0% in the adult population 19-80 y/o; incorporating SOBERANA Plus increased efficacy from 71.0 % to 92.4%.
November 1, 2021 - A non-peer-reviewed study reported two doses of the conjugate vaccine SOBERANA 02 was safe and attained efficacy of 71% in the adult’s population 19-80 y/o; incorporating SOBERANA Plus after two doses of SOBERANA 02, increased efficacy from 71% to 92.4% (Clinical Trials IFV/COR/09 number, RPCEC00000354.)
October 24, 2021 - China media reported the Cuban Ministry of Public Health on Sunday announced 62% of Cubans are now fully immunized with either Soberana 02, Abdala, or Soberana Plus, the emergency authorized COVID-19 vaccines. And, the Cuban government announced travel restrictions may ease beginning November 1, 2021, reported Xinhua.
October 11, 2021 - The results of the phase III clinical trial developed by the Pasteur Institute of Iran confirm the efficacy of the SOBERANA-02 and SOBERANA Plus vaccines against the Delta strain. The interim analysis showed that the efficacy of the vaccine in preventing hospitalization confirmed by COVID-19 on the two-dose regimen was 76.8% and in the three-dose regimen it was 91.7%. In 87.9% of participants in the two-dose regimen group and 98.8% of participants in the three-dose regimen, a 4-fold increase in serum titer or a change from negative was observed a positive in the serum titer.
October 5, 2021 - The AP reported Nicaragua Vice President Rosario Murillo confirmed the country will get seven million doses of Cuban coronavirus vaccines over the next three months.
October 2, 2021 - The Health Regulation Authority of the Nicaraguan Ministry of Health Tweeted it granted an Emergency Use Certification to the Cuban vaccine Soberana.
September 16, 2021 - Cuba began a vaccination campaign for children between the ages of two and 10. Health officials in the country say Cuba's homegrown vaccines have been found safe for young children.
September 15, 2021 - French media reported the World Health Organization vetting process would start for Abdala and Soberana 02 vaccines, said Rolando Perez of state pharma group BioCubaFarma.
September 6, 2021 - Summary of the results of the SOBERANA-PEDIATRÍA Clinical Trial: "Phase I-II study, sequential during phase I, open, adaptive and multicenter to evaluate the safety, reactogenicity and immunogenicity, of a heterologous two-dose schedule of the prophylactic anti-SARS-CoV-2 vaccine candidate, FINLAY-FR - 2 and a dose of FINLAY-FR-1A, in Cuban children and adolescents." Finding: The SOBERANA02 vaccine is well tolerated after administering two doses in children and adolescents aged 3-18 years of Phases I / II.
September 3, 2021 - The Center for State Control of Medicines, Equipment, and Medical Devices approved the Authorization for Emergency Use for the Cuban vaccine SOBERANA 02, whose owner is the Finlay Vaccine Institute, to expand its indication in the pediatric population aged between 2 to 18 years of age
August 17, 2021 - The journal Nature reported: Iran hopes to defeat COVID with the home-grown crop of vaccines. The Soberana 02 vaccine from Cuba received emergency-use approval in Iran in June 2021.
August 13, 2021 - Reuters reported Cuba confirmed on local TV the Delta variant "only 21,000," or 0.8% of the 2.5 million people inoculated with its homegrown vaccines, had fallen ill with the disease so far.
August 5, 2021 - The BMJ published: Why Cuba developed its own covid vaccine—and what happened next.
July 28, 2021 - BioWorld reported interim data for Soberana-02, a Cuban COVID-19 conjugate vaccine, surpassed the threshold set by the WHO, according to the Finlay Institute of Vaccine in Havana. The study results have not been peer-reviewed.
July 23, 2021 - The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved the Phase II, randomized, double-blind, parallel-group, adaptive and multicenter clinical trial to evaluate the non-inferiority of the immune response in adults of the vaccine candidate prophylactic anti-SARS-CoV-2 FINLAY-FR-1 compared to FINLAY-FR-2 in heterologous regimens of two doses and a booster dose with FINLAY-FR-1A ."
July 20, 2021 - Representatives of Global Health Partners held a press conference. They presented a certificate to the Cuban Embassy in Washington DC, symbolizing a donation of six million syringes to Cuba for their COVID-19 vaccination campaign.
July 8, 2021 - Cuba biopharmaceutical corporation BioCubaFarma announced the Soberana 2 vaccine, delivered with a booster called Soberana Plus, had proven 91.2% effective in a late-stage clinical trial.
July 8, 2021 - The WSJ reported 10,000 people in Venezuela received the first vaccine dose of the three-dose vaccine called Abdala in recent days at a Caracas military base.
July 6, 2021 - Prensa Latina reported an assessment of Cuban anti-Covid Soberana 02 vaccine candidate reached the US magazine ACS Chemical Biology.
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 the Ministry of Public Health statistics, 578,385 Cubans have already been vaccinated with the Abdala or Soberana 2 candidates, 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. According to the company's chief Eduardo Martinez, by then, BioCubaFarma will have produced enough doses to immunize all of the island's inhabitants.
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 6,234 patients with COVID-19 admitted to its hospitals, the highest number for a day since 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 conjugate 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 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 conjugate 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. The Cuban Center for Molecular Immunology head, Eduardo Ojito, 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 8, 2021 - Taking into account the preclinical data, as well as the clinical safety results collected in Phase I and Phase II studies, the immunogenicity results obtained in the Phase I clinical trial and preliminary Phase II, and considering the need to advance towards other phases of product development; CECMED was presented with the file requesting a Phase III clinical trial with the vaccine candidate Soberana02. This was approved on March 3, 2021, by CECMED.
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. The Finlay Institute requested authorization to start Phase 1 clinical trial in healthy adults from the Center for State Control Medicines, Equipment, and Medical Devices.
Soberana COVID-19 Vaccine Clinical Trials
Soberana 02 COVID-19 Vaccine has been in human clinical trials since October 30, 2020.
A separate Phase 3 study of a three-dose heterologous vaccine enrolled over 40,000 participants in various clinics throughout Havana. The non-peer-reviewed results were published on 11/01/2021. The heterologous three-dose combination with SOBERANA Plus protected against symptomatic COVID-19: 15 cases in the vaccine groups (13 833) vs. 155 in the placebo group (14 303), VE 92.4%, adjusted (CI 95% 86.9-95.6%). For two-dose schedule VE against severe COVID-19 was 63.0% and for death 59.0%; for heterologous three-dose schedule, 100% in both cases.
A Phase 3 study which was developed by the Pasteur Institute of Iran confirmed the efficacy of the SOBERANA VACCINES against the Delta strain of the virus. The double-blind, randomized, placebo-controlled trial enrolled 24,000 subjects who used the SOBERANA-02 vaccine in a two-dose regimen in eight cities and a booster dose (three-dose regimen) with the SOBERANA-Plus vaccine in 2 cities. During the trial, the Delta variant July (71.9%) and August (95.4%) was widely predominant. The vaccine efficacy in preventing hospitalization was 76.8% with the two-dose regimen and 91.7% in the three-dose regimen.
Based on the results of the Phase I / II trial in pediatric ages with SOBERANA02, on August 27, 2021, CECMED was requested to extend the authorization of emergency use for a population between 3 and 18 years of age, and it was requested to include the cohort of children between 2 -3 years in the authorization under clinical and epidemiological arguments endorsed by the National Group of Pediatrics. Therefore, on September 3, CECMED authorized the use of emergencies for ages 2-18 years. On September 5, 2021, the vaccination of children and adolescents of these ages begins, beginning in the province of Cienfuegos and with an extension schedule throughout the country according to MINSAP planning.