SOBERANA, Cuba’s COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD Director of Research, Finlay Vaccine Institute
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Medical Education Cooperation with Cuba
2020
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| author | Conner Gorry |
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| contents | SOBERANA, Cuba’s COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD Director of Research, Finlay Vaccine Institute Conner Gorry Medicina 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 and the first from Latin America and the Caribbean. On August 24, parallel Phase I/II double blind, randomized, controlled clinical trials were launched at clinical sites in Havana to evaluate the vaccine’s safety and immunogenicity. Analysis of results and development of different formulations are currently under way and Phase III clinical trials are planned for early 2021. At the time of writing, a second vaccine candidate, SOBERANA 02, was in late-stage development and preparing to begin separate trials this fall.Cuba’s biotech industry, comprised of more than 30 research institutes and manufacturing companies in the state-owned conglomerate BioCubaFarma, has developed and distributed vaccines according to international standards of good clinical and manufacturing practices and protocols for decades. BioCubaFarma supplies over 800 products to Cuba’s national health system—349 of those are on Cuba’s Basic Drug List, the medicines approved for use in the country’s health system. Additionally, BioCubaFarma has 2438 patents registered outside Cuba and its products, including vaccines, medicines and medical equipment, are in 100 simultaneous trials at 200 clinical sites and are registered and sold in more than 50 countries.These factors proved advantageous for making a fast, confident pivot towards COVID-19 vaccine development. Specifically, these antecedents meant all necessary technical capacities and regulatory certifications were already in place. Founded in 1989, CECMED was certified as a WHO Level 4 Regulatory Authority of Reference for vaccine control (the highest certification level conferred) in 2017; also in 1989, a team at Cuba’s Finlay Vaccine Institute led by Dr Concepción Campa, developed VA-MENGOC-BC, the world’s first safe, effective vaccine against serogroup B meningococcus; and in 2000, Cuba’s recombinant hepatitis B vaccine received WHO-PAHO pre-qualification. To date, millions of people in Cuba and elsewhere have been immunized against a variety of diseases with vaccines from the island.Shortly after COVID-19 was declared a pandemic by WHO, this expertise was marshaled to develop a Cuban vaccine against the disease. Researchers from the Finlay Vaccine Institute (IFV), the Molecular Immunology Center (CIM) and the University of Havana’s Chemical and Biomolecular Synthesis Laboratory, with support from other BioCubaFarma enterprises, are leading the project aimed at delivering a safe, effective vaccine in 2021.The SOBERANA team, which is working on two vaccine candidates, SOBERANA 01 and SOBERANA 02 and several formulations thereof, is led by Dr Vicente Vérez-Bencomo, IFV Director, Dr Yury Valdés Balbín, IFV Deputy Director; and Dr Dagmar García Rivera, IFV’s Director of Research, a post she has held since 2014. A vaccin 2020 artículo científico 1555-7960 https://www.redalyc.org/articulo.oa?id=437565248013 https://www.redalyc.org/journal/4375/437565248013/ https://www.redalyc.org/journal/4375/437565248013/html/ https://www.redalyc.org/journal/4375/437565248013/437565248013.epub https://www.redalyc.org/journal/4375/437565248013/movil https://doi.org/10.37757/MR2020.V22.N4.11 en http://www.redalyc.org/revista.oa?id=4375 MEDICC Review application/pdf Medical Education Cooperation with Cuba MEDICC Review (Estados Unidos de América) Num.4 Vol.22 |
| format | Artículo científico |
| id | redalyc_437565248013 |
| institution | Redalyc |
| language | en |
| publishDate | 2020 |
| publisher | Medical Education Cooperation with Cuba |
| spellingShingle | SOBERANA, Cuba’s COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD Director of Research, Finlay Vaccine Institute Conner Gorry Medicina SOBERANA, Cuba’s COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD Director of Research, Finlay Vaccine Institute Conner Gorry Medicina 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 and the first from Latin America and the Caribbean. On August 24, parallel Phase I/II double blind, randomized, controlled clinical trials were launched at clinical sites in Havana to evaluate the vaccine’s safety and immunogenicity. Analysis of results and development of different formulations are currently under way and Phase III clinical trials are planned for early 2021. At the time of writing, a second vaccine candidate, SOBERANA 02, was in late-stage development and preparing to begin separate trials this fall.Cuba’s biotech industry, comprised of more than 30 research institutes and manufacturing companies in the state-owned conglomerate BioCubaFarma, has developed and distributed vaccines according to international standards of good clinical and manufacturing practices and protocols for decades. BioCubaFarma supplies over 800 products to Cuba’s national health system—349 of those are on Cuba’s Basic Drug List, the medicines approved for use in the country’s health system. Additionally, BioCubaFarma has 2438 patents registered outside Cuba and its products, including vaccines, medicines and medical equipment, are in 100 simultaneous trials at 200 clinical sites and are registered and sold in more than 50 countries.These factors proved advantageous for making a fast, confident pivot towards COVID-19 vaccine development. Specifically, these antecedents meant all necessary technical capacities and regulatory certifications were already in place. Founded in 1989, CECMED was certified as a WHO Level 4 Regulatory Authority of Reference for vaccine control (the highest certification level conferred) in 2017; also in 1989, a team at Cuba’s Finlay Vaccine Institute led by Dr Concepción Campa, developed VA-MENGOC-BC, the world’s first safe, effective vaccine against serogroup B meningococcus; and in 2000, Cuba’s recombinant hepatitis B vaccine received WHO-PAHO pre-qualification. To date, millions of people in Cuba and elsewhere have been immunized against a variety of diseases with vaccines from the island.Shortly after COVID-19 was declared a pandemic by WHO, this expertise was marshaled to develop a Cuban vaccine against the disease. Researchers from the Finlay Vaccine Institute (IFV), the Molecular Immunology Center (CIM) and the University of Havana’s Chemical and Biomolecular Synthesis Laboratory, with support from other BioCubaFarma enterprises, are leading the project aimed at delivering a safe, effective vaccine in 2021.The SOBERANA team, which is working on two vaccine candidates, SOBERANA 01 and SOBERANA 02 and several formulations thereof, is led by Dr Vicente Vérez-Bencomo, IFV Director, Dr Yury Valdés Balbín, IFV Deputy Director; and Dr Dagmar García Rivera, IFV’s Director of Research, a post she has held since 2014. A vaccin 2020 artículo científico 1555-7960 https://www.redalyc.org/articulo.oa?id=437565248013 https://www.redalyc.org/journal/4375/437565248013/ https://www.redalyc.org/journal/4375/437565248013/html/ https://www.redalyc.org/journal/4375/437565248013/437565248013.epub https://www.redalyc.org/journal/4375/437565248013/movil https://doi.org/10.37757/MR2020.V22.N4.11 en http://www.redalyc.org/revista.oa?id=4375 MEDICC Review application/pdf Medical Education Cooperation with Cuba MEDICC Review (Estados Unidos de América) Num.4 Vol.22 |
| title | SOBERANA, Cuba’s COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD Director of Research, Finlay Vaccine Institute |
| topic | Medicina |
| url | https://www.redalyc.org/articulo.oa?id=437565248013 https://www.redalyc.org/journal/4375/437565248013/ https://www.redalyc.org/journal/4375/437565248013/html/ https://www.redalyc.org/journal/4375/437565248013/437565248013.epub https://www.redalyc.org/journal/4375/437565248013/movil https://doi.org/10.37757/MR2020.V22.N4.11 |