Abdala (vaccine)

Short description: Vaccine against COVID-19

AbdalaVaccine description

Target disease| SARS-CoV-2
Type| Protein subunit
Clinical data
Other names| ABDALA
Routes of
administration| Intramuscular
Legal status
Legal status|

* Full and emergency authorizations

Full list of Abdala authorizations

Abdala, technical name CIGB-66, is a COVID-19 vaccine developed by the Center for Genetic Engineering and Biotechnology in Cuba.[1] This 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.[2] The full results of the clinical trial have not yet been published. This candidate followed a previous one called CIGB-669 (MAMBISA).[3]

The vaccine is one of two Cuba-developed COVID-19 vaccines which has passed Phase III trials,[4][5][6] and has received emergency authorisation.

## Contents

* 1 Medical uses
* 1.1 Efficacy
* 2 Vaccine design
* 3 Manufacturing
* 4 History
* 4.1 Clinical trials
* 4.1.1 Intervention study
* 4.2 Authorizations
* 5 Economics
* 6 References
* 7 External links

## Medical uses

The vaccine was administered in 3 doses spaced 2 weeks apart.[7]

### Efficacy

On 22 June 2021, The official Cuban government sources reported that the results of an initial study by the Cuban Center for Genetic Engineering and Biotechnology involving 48,290 participants found a 92.28% efficacy rate[8][9][10][11] at preventing symptomatic COVID-19.[12][13] The report included a confidence interval of 85.74%–95.817% without a specified confidence level; analysis was based on 153 cases of symptomatic COVID, 142 of which were in the placebo group and 11 of which were in the approximately equal vaccinated group.[13]

The measure of efficacy includes the initial strain of SARS-COV-2 as well as variants that were present in Cuba during the study,[14] including Alpha, Beta, and Gamma strains.[12] The Beta variant entered Cuba in January 2021 and became the predominant strain in Cuba,[15][16][17] fuelling a rise in COVID cases.[18]

As of 28 June 2021, Cuba has not yet released detailed information about the vaccine to the WHO[11] or to the general public via a pre-print or a scientific article.[19] It is planned to do so after the Cuba Health Agency (CECMED) authorises the vaccine for emergency use.[13][20]

## Vaccine design

The vaccine was designed by researchers from the Center for Genetic Engineering and Biotechnology and has been described in a pre-print submission.[21] The Abdala vaccine reportedly consists of a monomeric receptor binding domain subunit, residues 331-530 of the Spike protein of SARS-CoV-2 strain 156 Wuhan-Hu-1, expressed in the yeast Pichia pastoris at 30–40 mg/L fermentation yield.[21] The vaccine antigen is polyhistidine-tagged to aid purification and is reportedly purified via immobilised metal affinity chromatography and subsequent hydrophobic interaction chromatography to >98% purity.[21] For animal studies 50 µg of vaccine antigen per dose was adjuvanted with 0.3 mg aluminium hydroxide gel (Alhydrogel) and delivered in 500 µL phosphate buffer.[21]

## Manufacturing

Venezuela has claimed that it will manufacture the vaccine[22] but, as of 2 May 2021, this claim had 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 reached by August or September 2021.[25] In June 2021, Vietnam's Ministry of Health announced that negotiations were ongoing between Cuba and Vietnam for Abdala vaccine production. The Institute of Vaccines and Medical Biologicals (IVAC) was named as the focal point for receiving technology transfer.[26]

## History

### Clinical trials

In July 2020, Abdala commenced phase I/II clinical trials.[27]

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,[28][29] and second doses started being administered from April 5.[30][better source needed] Third doses have started being administered on 19 April[31][32][33] and on May 1, adherence to the three-dose protocol was over 97%.[34]

In July 2021, Abdala started clinical trial phase I/II for children and adolescents aged 3-18.[35]

#### 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.[36]

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.[37]

### Authorizations

On 9 July 2021, Abdala approved for an emergency use authorization in Cuba.[38][39]

On 18 September 2021, Abdala was approved for an emergency use authorization in Vietnam.[40]

On 16 December 2021, the Ministry of Health of Saint Vincent and the Grenadines announced that the Abdala vaccine was available at vaccination sites across the island.[41] This announcement follows a donation of vaccines made by the Cuban government on 13 December 2021.[42]

On 29 December 2021, Abdala was approved for an emergency use authorization in Mexico.[43]

## Economics

On 24 June 2021, Vice President of Venezuela Delcy Rodríguez announced that Venezuela had signed a contract for 12 million doses of the vaccine, and that these doses are to arrive in "the coming months".[44] The first shipment of Abdala arrived in Venezuela the day following this announcement.[45]

On 20 September, 2021, The Vietnamese Government has issued a resolution on purchase of 10 million doses of Abdala COVID-19 vaccine.[46]

## References

1. ↑ "ABDALA Clinical Study". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000346-En.
2. ↑ "Cuba's five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa" (in en-UK). 31 March 2021. 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.
3. ↑ "MAMBISA Study". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000345-En.
4. ↑ "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.
5. ↑ "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.
6. ↑ "Coronavirus Vaccine Tracker" (in en-US). The New York Times. 10 June 2020. ISSN 0362-4331. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html.
7. ↑ "ABDALA Clinical Study - Phase III". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000359-En.
8. ↑ "Cuba says Abdala vaccine 92.28% effective against coronavirus". 2021-06-21. https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-says-abdala-vaccine-9228-effective-against-coronavirus-2021-06-21/.
9. ↑ "Cuba reports a high success rate for its homegrown Abdala vaccine." (in en-US). The New York Times. 2021-06-22. ISSN 0362-4331. https://www.nytimes.com/2021/06/22/world/americas/cuba-vaccine-abdala.html.
10. ↑ "Cuba's COVID-19 vaccine Abdala shows 92 pct efficacy, makers say" (in en). 2021-06-22. https://english.alarabiya.net/coronavirus/2021/06/22/Cuba-s-COVID-19-vaccine-Abdala-shows-92-pct-efficacy-makers-say-.
11. ↑ 11.0 11.1 "Cuba says two of its vaccines are effective against COVID-19. But where is the data?". Miami Herald. June 23, 2021. https://www.miamiherald.com/news/nation-world/world/americas/cuba/article252264428.html.
12. ↑ 12.0 12.1 "Abdala, con tres dosis, tiene una eficacia de 92,28 % (+Video)" (in es). http://www.granma.cu/cuba/2021-06-21/abdala-con-tres-dosis-tiene-una-eficacia-de-9228-porciento-21-06-2021-21-06-01.
13. ↑ 13.0 13.1 13.2 "How was the efficacy of the Cuban COVID-19 vaccine candidates calculated?" (in en-US). 2021-06-27. https://oncubanews.com/en/cuba/how-was-the-efficacy-of-the-cuban-covid-19-vaccine-candidates-calculated/.
14. ↑ "Efficacy, resistance to variants, approval … 3 things to know about the Cuban vaccine Abdala" (in en-us). 2021-06-22. https://news.in-24.com/world/82717.html.
15. ↑ Ministerio de Salud Pública en Cuba (2021-01-22). "Cuba reporta la presencia de una nueva variante genética de SARS-CoV-2" (in es-ES). https://salud.msp.gob.cu/cuba-reporta-la-presencia-de-una-nueva-variante-genetica-de-sars-cov-2/.
16. ↑ "Cuba reports new coronavirus variant amid peak of cases" (in en-US). 2021-01-22. https://brazilian.report/liveblog/coronavirus/2021/01/22/cuba-reports-new-coronavirus-variant-amid-peak-of-cases/.
17. ↑ "Cuba detects South African COVID-19 variant amid virus uptick". Miami Herald. https://www.miamiherald.com/news/nation-world/world/americas/cuba/article248782480.html.
18. ↑ "South African virus variant fuels record Cuban COVID-19 cases" (in en). Reuters. 2021-04-22. https://www.reuters.com/article/health-coronavirus-cuba-idUSL8N2MF89T.
19. ↑ "Accelerating Availability of Vaccine Candidates for COVID-19". SSRN Electronic Journal. 2020. doi:10.2139/ssrn.3564664. ISSN 1556-5068.
20. ↑ "COVID-19: las vacunas cubanas son una "esperanza" para América Latina | DW | 23.06.2021" (in es-ES). https://www.dw.com/es/covid-19-las-vacunas-cubanas-son-una-esperanza-para-américa-latina/a-58007770.
21. ↑ 21.0 21.1 21.2 21.3 (in En) The SARS-CoV-2 receptor-binding domain expressed in Pichia pastoris as a candidate vaccine antigen July 3, 2021. 2021. doi:10.1101/2021.06.29.21259605. https://www.medrxiv.org/content/10.1101/2021.06.29.21259605v1. Retrieved 2021-11-23.
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. ↑ "Venezuela to produce Cuban COVID vaccine: Maduro". Al Jazeera and news agencies. 2021-04-12. https://www.aljazeera.com/news/2021/4/12/venezuela-to-produce-cuban-covid-jabs-maduro. ""We've signed an agreement to produce in our laboratories… two million vaccines a month of the Abdala vaccine… for August, September, approximately,""
26. ↑ Ministry of Health Vietnam (2021-06-16). "Bộ trưởng Bộ Y tế đàm phán với Cuba về hợp tác sản xuất vaccine" (in vi). https://giadinh.net.vn/news-20210616195904929.htm.
27. ↑ "ABDALA Clinical Study". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000346-En.
28. ↑ 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.
29. ↑ "Covid Check-in: Cuba's Homegrown Vaccines" (in en). https://www.as-coa.org/articles/covid-check-cubas-homegrown-vaccines.
30. ↑ 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.
31. ↑ "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.
32. ↑ 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.
33. ↑ Agencia Cubana de Noticias. "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.
34. ↑ "With Abdala, Cuba takes another step toward broad scale vaccination". Granma. 2021-05-04. http://en.granma.cu/cuba/2021-05-04/with-abdala-cuba-takes-another-step-toward-broad-scale-vaccination.
35. ↑ "Evaluation of the safety and immunogenicity of the vaccine candidate "ABDALA" in children and adolescents". Registro Público Cubano de Ensayos Clínicos. https://rpcec.sld.cu/en/trials/RPCEC00000381-En.
36. ↑ "ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos". https://rpcec.sld.cu/en/trials/RPCEC00000363-En.
37. ↑ Ministerio de Salud Pública en Cuba. "Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba" (in es-ES). https://salud.msp.gob.cu/.
38. ↑ "COVID: Cuba approves emergency use of own Abdala vaccine". Deutsche Welle. 9 July 2021. https://www.dw.com/en/covid-cuba-approves-emergency-use-of-own-abdala-vaccine/a-58222105.
39. ↑ "Aprueba el CECMED el Autorizo de Uso de Emergencia del candidato vacunal cubano ABDALA | CECMED" (in es). https://www.cecmed.cu/noticias/aprueba-cecmed-autorizo-uso-emergencia-candidato-vacunal-cubano-abdala.
40. ↑ "Vietnam approves emergency use of Cuba's Covid vaccine". VnExpress. September 18, 2021. https://ampe.vnexpress.net/news/news/vietnam-approves-emergency-use-of-cuba-s-covid-vaccine-4358343.html.
41. ↑ "Vincentians have access to Cuban Abdala vaccine | Loop Caribbean News" (in en). https://caribbean.loopnews.com/content/vincentians-have-access-cuban-abdala-vaccine.
42. ↑ "SVG receives 300 Abdala vaccines from Cuba" (in en-US). 2021-12-21. https://www.svg-tv.com/2021/12/21/svg-receives-300-abdala-vaccines-from-cuba/.
43. ↑ "Mexico authorizes Cuban COVID-19 vaccine for emergency use" (in en). December 29, 2021. https://wtvbam.com/2021/12/29/mexico-authorizes-cuban-covid-19-vaccine-for-emergency-use/.
44. ↑ "Venezuela announces acquisition of 12 million Cuban vaccine doses" (in en-GB). 2021-06-25. https://www.macaubusiness.com/venezuela-announces-acquisition-of-12-million-cuban-vaccine-doses/.
45. ↑ "Venezuela receives first shipment of Cuban coronavirus vaccine". 2021-06-24. https://www.reuters.com/world/americas/venezuela-receives-first-shipment-cuban-coronavirus-vaccine-2021-06-24/.
46. ↑ "Gov't to purchase 10 million doses of Cuba's COVID-19 vaccine". 2021-09-20. http://news.chinhphu.vn/Home/Govt-to-purchase-10-million-doses-of-Cubas-COVID19-vaccine/20219/45541.vgp.

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