Biology:ABDALA

From HandWiki
Short description: Vaccine candidate against COVID-19
ABDALA
Vaccine description
Target diseaseSARS-CoV-2
TypeProtein subunit
Clinical data
Other namesABDALA
Routes of
administration		Intramuscular

ABDALA, technical name CIGB-66, is a COVID-19 vaccine candidate developed by the Center for Genetic Engineering and Biotechnology in Cuba.[1][2] This vaccine candidate, named after a patriotic drama by Cuban independence hero José Martí, is a protein subunit vaccine containing COVID-derived proteins that trigger an immune response.[3] However, none of the clinical trial full results have been published. This candidate followed a previous one called CIGB-669 (MAMBISA).[4]

The vaccine is one of two Cuba-developed COVID-19 vaccines in Phase III trials.[5][6][7]

Clinical research

Phase I/II

In July 2020, CIGB-66 commenced phase I/II clinical trials.[8]

Phase III

The Phase III trial compares 3 doses of the vaccine administered at 0, 14 and 28 days against a placebo, with the primary outcome measuring the proportion of cases reported for each group 14 days after the third dose.

The trial was registered on 18 March 2021. The first dose was administered on 22 March and by April 4, the 48,000 participants had received their first dose,[9][10] and second doses started being administered from April 5.[11][12] Third doses have started being administered on 19 April[13][14][15] and on May 1, 97% of the original participants had received their 3 doses, the others 3% were lost in the process. From May 3, the efficacy of the vaccine will start being evaluated.[16][17][18]

The "first evaluation of efficacy" can begin when there is 50 cases, then there is a second evaluation at 100 cases and a definitive efficacy can "finally be demonstrated" at 150 cases, Cuban Center for Genetic Engineering and Biotechnology director said.[19]

Intervention study

124,000 people aged 19 to 80 received 3 doses of the vaccine as part of an intervention study, with the primary outcome measuring the proportion of cases and deaths for the vaccinated compared to the unvaccinated population.[20]

A wider intervention study with the 1.7 million inhabitants of Havana is expected to start in May with the ABDALA and Soberana 2 vaccine.[21]

Production outside Cuba

Venezuela has claimed that it will manufacture the vaccine[22] but this claim has not yet materialised.[23] State-owned EspromedBIO will manufacture the vaccine but some "arrangements" are needed to start production.[24] In April, Nicolás Maduro said that a capacity of 2 Million doses per month is hoped to be reach by "August, September approximately".[25]

References

  1. ↑ "ABDALA Clinical Study - Phase III". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000359-En. 
  2. ↑ "ABDALA Clinical Study". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000346-En. 
  3. ↑ "Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa" (in en-UK). https://blogs.lse.ac.uk/latamcaribbean/2021/03/31/cubas-five-covid-19-vaccines-the-full-story-on-soberana-01-02-plus-abdala-and-mambisa. 
  4. ↑ "MAMBISA Study". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000345-En. 
  5. ↑ "Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III" (in en). https://www.bioworld.com/articles/505740-three-shot-cuban-covid-19-vaccine-candidate-moves-forward-in-phase-iii. 
  6. ↑ "Cuba's Abdala COVID-19 vaccine enters phase 3 clinical trial - Xinhua | English.news.cn". http://www.xinhuanet.com/english/northamerica/2021-03/20/c_139823225.htm. 
  7. ↑ "Coronavirus Vaccine Tracker" (in en-US). The New York Times. ISSN 0362-4331. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html. 
  8. ↑ "ABDALA Clinical Study". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000346-En. 
  9. ↑ BioCubaFarma (April 4, 2021). "[Translated "The application of the 1st dose of #Abdala, in volunteer 48 thousand, of the Phase III Clinical Trial. Next Monday, April 5, the application of the 2nd dose of this vaccine candidate begins. #VcaunasCubanasCovid19 .""] (in en). https://twitter.com/biocubafarma/status/1378491247128629258/photo/1. 
  10. ↑ "Covid Check-in: Cuba's Homegrown Vaccines" (in en). https://www.as-coa.org/articles/covid-check-cubas-homegrown-vaccines. 
  11. ↑ BioCubaFarma (5 April 2021). "[Translated "The application of the 2nd dose of the vaccine candidates begins today #Abdala and #Soberana02 , as part of the 3rd phase of the clinical trial. Workers of @Emcomed1 in Havana and eastern provinces, from very early hours they carry out their distribution until the vaccination centers""] (in es). https://twitter.com/biocubafarma/status/1379024394215907329/photo/4. 
  12. ↑ "Two Cuban Vaccines Start Second Dose Phase III Trials" (in en-US). 2021-04-05. https://kawsachunnews.com/two-cuban-vaccines-start-second-dose-phase-iii-trials. 
  13. ↑ "Abdala: Comienza tercera dosis en el Oriente cubano" (in es). http://www.cuba.cu/salud/2021-04-19/abdala-comienza-tercera-dosis-en-el-oriente-cubano-/55583. 
  14. ↑ BioCubaFarma. "[Translated "Application of the 3rd dose of the vaccine candidate begins #Abdala in the provinces of Granma, Santiago de Cuba and Guantánamo. The application of the 2nd dose of #Soberana02 within the framework of the EC Phase III.#VacunasCubanasCovid19"] (in en). https://twitter.com/biocubafarma/status/1384146743281946628. 
  15. ↑ Noticias, Agencia Cubana de. "Convergen múltiples voluntades para éxito de estudio Abdala en Bayamo" (in es-es). http://www.acn.cu/salud/78805-convergen-multiples-voluntades-para-exito-de-estudio-abdala-en-bayamo. 
  16. ↑ "Scientists announce Abdala's administration of 3rd dose will finish" (in es-ES). http://www.plenglish.com/index.php?o=rn&id=66941&SEO=scientists-announce-abdalas-administration-of-3rd-dose-will-finish. 
  17. ↑ Noticias, Agencia Cubana de. "Concluye aplicación de vacuna Abdala en Oriente de Cuba" (in es-es). http://www.acn.cu/salud/79220-concluye-aplicacion-de-vacuna-abdala-en-oriente-de-cuba. 
  18. ↑ "Cuba conclui ensaios clínicos de candidata a vacina contra covid-19" (in pt-br). 2021-05-02. http://noticias.r7.com/internacional/cuba-conclui-ensaios-clinicos-de-candidata-a-vacina-contra-covid-19-02052021. 
  19. ↑ "Abdala cerca de concluir la fase III de ensayos clínicos; Mambisa se alista para avanzar a nueva fase (+Video)" (in es). http://www.granma.cu/cuba/2021-04-27/abdala-cerca-de-concluir-la-fase-iii-de-ensayos-clinicos-mambisa-se-alista-para-avanzar-a-nueva-fase. 
  20. ↑ "ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos". https://rpcec.sld.cu/en/trials/RPCEC00000363-En. 
  21. ↑ Cuba, Ministerio de Salud P�blica en. "Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba" (in es-ES). https://salud.msp.gob.cu/. 
  22. ↑ "Cuba says it's 'betting it safe' with its own Covid vaccine" (in en). https://www.nbcnews.com/news/latino/cuba-says-betting-safe-covid-vaccine-rcna643. 
  23. ↑ "Maduro struggles to make his grand vaccine promise" (in en-US). 2021-05-02. https://eminetra.co.uk/maduro-struggles-to-make-his-grand-vaccine-promise/447785/. 
  24. ↑ "Venezuela producirá la vacuna cubana anticovid Abdala" (in es). https://www.efe.com/efe/america/sociedad/venezuela-producira-la-vacuna-cubana-anticovid-abdala/20000013-4507410. 
  25. ↑ Apr 11, Reuters /; 2021; Ist, 16:27. "Indonesian President orders Java rescue efforts after quake kills 8 - Times of India" (in en). https://timesofindia.indiatimes.com/world/rest-of-world/indonesian-president-orders-java-rescue-efforts-after-quake-kills-8/articleshow/82016555.cms. 

External links




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