A SARS-CoV-2 vaccine comprising a conjugate of the spike protein RBD domain with tetanus toxoid (Finlay Vaccine Institute of Cuba)
Soberana 02, is a conjugate vaccine developed by Instituto Finlay de Vacunas.
517 Zimmer, Carl; Corum, Jonathan; Wee, Sui-Lee. “Coronavirus Vaccine Tracker”. The New York Times. Retrieved 30 June 2021.
518 Sesin, Carmen (14 May 2021). “Cuba begins mass Covid-19 vaccine inoculation before concluding trials”. NBC News. Retrieved 2 July 2021.
Soberana 02, technical name FINLAY-FR-2, is a COVID-19 vaccine produced by the Finlay Institute, a Cuban epidemiological research institute. It is a conjugate vaccine. This candidate followed a previous one called SOBERANA-01 (FINLAY-FR-1). 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. According to the WHO candidate landscape vaccine document, this vaccine requires two doses, the second one being administered 28 days after the first shot.
The spike protein subunit is produced in Chinese hamster ovary cell culture. In a pre-print article scientists from Cuba explain details of the vaccines technology and production.[non-primary source needed]
Production Deliveries Planned Production Potential Production
Deliveries (0)Effective production (implies deliveries) (1)
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).
Vietnam, Iran, Venezuela, Argentina, Pakistan, India, the African Union, Jamaica and Suriname have expressed interest in purchasing the vaccine, although they are waiting on 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.
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.
Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years. Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days. The second phase has been supervised by Iranian officials from the Pasteur Institute.
Phase III commenced at the beginning of March as originally scheduled, and “ready to publish” results are expected by June. The trial volunteers are divided into three groups: some will receive two doses of the vaccine 28 days apart, another group will get two doses plus a third immune booster (Soberana Plus), and the third a placebo.
Although the trials involve thousands of adult volunteers recruited in Havana, Cuba’s public health officials have said that they will also need to conduct phase III trials abroad because the island doesn’t have an outbreak of sufficient scale to produce meaningful statistics on vaccine protection.
On March 13, 2021, the Cuban Biotechnology and Pharmaceutical Industries Business Group (BioCubaFarma) announced on social media that it had sent 100,000 doses of its Soberana 02 coronavirus vaccine candidate to the Pasteur Institute of Iran for clinical testing, “as part of the collaboration with other countries in the development of COVID-19 vaccines.” 
On April 26, 2021, it was reported that a Phase III conducted by the Pasteur Institute of Iran was approved to be started in Iran It was previously reported that the Institute will host Phase 3 but the pre-requisites were “technology transfer and joint production”.
Mexico plans to host a phase 3 trial.
The “Interventional Study” is set both in Havana, Cuba’s capital and Santiago de Cuba, Cuba’s second most populous city  and in other provinces. On May 6, 2021, the Finlay Institute of Vaccines announced on social media that the following adverse events have been observed: injection site pain (20%), inflammation at the injection site (5%), and general discomfort (5%).
Full authorization Emergency authorization
- ^ “Cuba’s Soberana Plus against Covid-19 is showing good results”. Prensa Latina. Retrieved 10 May 2021.
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- ^ Santos IC (January 2021). “Rapid response to: Covid 19: Hope is being eclipsed by deep frustration”. BMJ. 372: n171. doi:10.1136/bmj.n171.
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- ^ Valdes-Balbin, Yury; Santana-Mederos, Darielys; Quintero, Lauren; Fernández, Sonsire; Rodriguez, Laura; Ramirez, Belinda Sanchez; Perez, Rocmira; Acosta, Claudia; Méndez, Yanira; Ricardo, Manuel G.; Hernandez, Tays (2021-02-09). “SARS-CoV-2 RBD-Tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies”. doi:10.1101/2021.02.08.430146.
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Las expectativas sobre Soberana 02 son tales que el titular del organismo estatal que desarrolló la vacuna, Vicente Vérez, confirmó que mientras se aguarden los resultados de la Fase 3 solo en La Habana, en abril se dará inicio a la producción del primer lote, de alrededor de 100 mil dosis.
- ^ “Cuba anuncia fase 3 de la vacuna Soberana 02”. La Jornada(in Spanish). 7 February 2021.
Una vez que superen las etapas clínicas, la OMS podría contar con el fármaco cubano, afirmó Moya, y “pasar a ser parte del grupo de vacunas que se oferten a través del Fondo Rotatorio”, un mecanismo que desde hace cuatro décadas permite gestionar antígenos e insumos a los países de las Américas.
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- ^ Ministry of Public Health of Cuba (11 April 2021). “[Translated] “The administration of the 1st dose of the Cuban vaccine candidates #Soberana02 and #Abdala to the 75 thousand health workers and Biocubafarma who are part of the intervention study taking place in #LaHabana has concluded.””. Twitter. Retrieved 2021-04-11.
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- ^ Yaffe, Helen. “Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa”. LSE Latin America and Caribbean blog. Retrieved 2021-03-31.
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- ^ “América Latina apura una vacuna propia. Cuba, adelante; México avanza. Pero no son los únicos”. http://www.poresto.net (in Spanish). Retrieved 2021-04-28.
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- ^ “Mexico Hopes to Work With Cuba on Covid Vaccine Phase 3 Trial”. Bloomberg.com. 2021-02-14. Retrieved 2021-05-07.
- ^ Marsh, Sarah (2021-03-24). “Nearly all Havana to receive experimental Cuban COVID-19 vaccines”. Reuters. Retrieved 2021-04-28.
- ^ BioCubaFarma (April 6, 2021). “[Translated] Updating the vaccination process with vaccine candidates #Soberana02 and #Abdala during ongoing clinical trials.#VacunasCubanasCovid19”. Twitter (in Spanish). Retrieved 2021-04-11.
- ^ “Intervention study with Covid-19 vaccine candidate Abdala begins”. Radio Cadena Agramonte. Retrieved 2021-04-28.
- ^ “Cuba administers over 62,000 doses in intervention trials”. http://www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials (in Spanish). Retrieved 2021-04-28.
- ^ “[Trnslated] In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: 👉 Pain at the injection site (20%). 👉 Redness at the injection site (5%). 👉 Feeling of general malaise (5%)”. Twitter. Retrieved 2021-05-07.
- ^ “[Translated]In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: 👉 Pain at the injection site (20%). 👉 Redness at the injection site (5%). 👉 Feeling of general malaise (5%)”. Facebook. Retrieved 2021-05-07.
|Other names||FINLAY-FR-2, SOBERANA PLUS|
|Legal status||Full and Emergency Authorizations: List of Soberana 02 authorizations|
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