Wikipedia

Abdala (vaccine)

This article is about the Cuban vaccine. For other uses, seeAbdala.

Abdala,technical nameCIGB-66,is aCOVID-19 vaccinedeveloped by theCenter for Genetic Engineering and BiotechnologyinCuba.[2]This candidate, named after a patriotic drama by Cuban independence heroJosé Martí,is aprotein subunit vaccinecontaining COVID-derived proteins that trigger an immune response.[3]The full results of the clinical trial have not yet been published. This candidate followed a previous one called CIGB-669 (MAMBISA).[4]

Abdala
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Other namesABDALA
Routes of
administration		Intramuscular
Legal status
Legal status
  • Full and emergency authorizations
Full list of Abdala authorizations
Identifiers
CAS Number

The vaccine is one of two Cuba-developedCOVID-19 vaccineswhich has passedPhase IIItrials,[5][6][7]and has received emergency authorisation.

Medical uses

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The vaccine was administered in 3 doses spaced 2 weeks apart.[8]

Efficacy

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On 22 June 2021, The official Cuban government sources reported that the results of an initial study by theCuban Center for Genetic Engineering and Biotechnologyinvolving 48,290 participants found a 92.28% efficacy rate[9][10][11][12]at preventing symptomatic COVID-19.[13][14]The report included aconfidence intervalof85.74%–95.817%without a specifiedconfidence 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.[14]

The measure of efficacy includes the initial strain ofSARS-COV-2as well as variants that were present in Cuba during the study,[15]includingAlpha,Beta,andGammastrains.[13]TheBeta variantentered Cuba in January 2021 and became the predominant strain in Cuba,[16][17][18]fuelling a rise in COVID cases.[19]

As of 28 June 2021, Cuba has not yet released detailed information about the vaccine to theWHO[12]or to thegeneral publicvia apre-printor ascientific article.[20]It is planned to do so after the Cuba Health Agency (CECMED) authorises the vaccine for emergency use.[14][21]

In September 2022 a study was published on the journal The Lancet Regional Health - Americas[22]concluding that the estimated vaccine effectiveness against severe illness was 93·3% in partially- vaccinated, 98·2% in fully-vaccinated. While against death was 94·1% in partially-vaccinated and 98·7% in fully-vaccinated. The effectiveness exceeded 92·0% in all age groups. It was a retrospective study under real-world during the wave of the Delta variant in Cuba. So it is unknown how effective would be against Omicron or posterior variants.

Vaccine design

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The vaccine was designed by researchers from theCenter for Genetic Engineering and Biotechnologyand has been described in a pre-print submission.[23]The Abdala vaccine reportedly consists of a monomericreceptor binding domainsubunit, residues 331-530 of the Spike protein of SARS-CoV-2 strain 156 Wuhan-Hu-1, expressed in the yeastPichia pastorisat 30–40 mg/L fermentation yield.[23]The vaccine antigen ispolyhistidine-taggedto aid purification and is reportedly purified viaimmobilised metal affinity chromatographyand subsequent hydrophobic interaction chromatography to >98% purity.[23]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.[23]

Manufacturing

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Venezuela has claimed that it will manufacture the vaccine[24]but, as of 2 May 2021, this claim had not yet materialised.[25]State-owned EspromedBIO will manufacture the vaccine but some "arrangements" are needed to start production.[26]In April,Nicolás Madurosaid that a capacity of 2 million doses per month is hoped to be reached by August or September 2021.[27]In June 2021,Vietnam's Ministry of Healthannounced 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.[28]

History

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Clinical trials

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In July 2020, Abdala commenced phase I/II clinical trials.[29]

The Phase III trial compares 3 doses of the vaccine administered at 0, 14 and 28 days against aplacebo,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,[30][31]and second doses started being administered from April 5.[32][better source needed]Third doses have started being administered on 19 April[33][34][35]and on May 1, adherence to the three-dose protocol was over 97%.[36]

In July 2021, Abdala started clinical trial phase I/II for children and adolescents aged 3-18.[37]

Intervention study

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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.[38]

A wider intervention study with the 1.7 million inhabitants of Havana is expected to start in May with the Abdala andSoberana 2 vaccine.[39]

Authorizations

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Full authorization
Emergency authorization
Allowed for travel
See also:List of COVID-19 vaccine authorizations § Abdala

On 9 July 2021, Abdala was approved for emergency use in Cuba.[40][41]

On 18 September 2021, Abdala was approved for emergency use in Vietnam.[42]

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.[43]This announcement follows a donation of vaccines made by the Cuban government on 13 December 2021.[44]

On 29 December 2021, Abdala was approved for emergency use in Mexico.[45]

Distribution

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On 24 June 2021,Vice President of VenezuelaDelcy Rodríguezannounced that Venezuela had signed a contract for 12 million doses of the vaccine, and that these doses are to arrive in "the coming months".[46]The first shipment of Abdala arrived in Venezuela the day following this announcement.[47]

On 20 September, 2021, The Vietnamese Government has issued a resolution on purchase of 10 million doses of Abdala COVID-19 vaccine.[48]

References

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  1. ^"Patent Landscape Report COVID-19-related vaccines and therapeutics"(PDF).
  2. ^"ABDALA Clinical Study".rpcec.sld.cu.Registro Público Cubano de Ensayos Clínicos.Retrieved22 March2021.
  3. ^Yaffe H (31 March 2021)."Cuba's five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa".LSE Latin America and Caribbean blog.Retrieved31 March2021.
  4. ^"MAMBISA Study".rpcec.sld.cu.Registro Público Cubano de Ensayos Clínicos.Retrieved22 March2021.
  5. ^"Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III".bioworld.Retrieved10 April2021.
  6. ^"Cuba's Abdala COVID-19 vaccine enters phase 3 clinical trial - Xinhua | English.news.cn".xinhuanet.Retrieved10 April2021.
  7. ^Zimmer C, Corum J, Wee SL (10 June 2020)."Coronavirus Vaccine Tracker".The New York Times.ISSN0362-4331.Retrieved10 April2021.
  8. ^"ABDALA Clinical Study - Phase III".rpcec.sld.cu.Registro Público Cubano de Ensayos Clínicos.Retrieved22 March2021.
  9. ^"Cuba says Abdala vaccine 92.28% effective against coronavirus".Reuters.21 June 2021.Retrieved25 June2021.
  10. ^Augustin E (22 June 2021)."Cuba reports a high success rate for its homegrown Abdala vaccine".The New York Times.ISSN0362-4331.Retrieved25 June2021.
  11. ^"Cuba's COVID-19 vaccine Abdala shows 92 pct efficacy, makers say".Al Arabiya English.22 June 2021.Retrieved25 June2021.
  12. ^ab"Cuba says two of its vaccines are effective against COVID-19. But where is the data?".Miami Herald.23 June 2021.Retrieved25 June2021.
  13. ^ab"Abdala, con tres dosis, tiene una eficacia de 92,28 % (+Video)".Granma.cu(in Spanish). 21 June 2021.Retrieved22 June2021.
  14. ^abc"How was the efficacy of the Cuban COVID-19 vaccine candidates calculated?".OnCubaNews English.27 June 2021.Retrieved28 June2021.
  15. ^"Efficacy, resistance to variants, approval... 3 things to know about the Cuban vaccine Abdala".News in 24 english.22 June 2021. Archived fromthe originalon 16 November 2021.Retrieved28 June2021.
  16. ^Ministerio de Salud Pública en Cuba (22 January 2021)."Cuba reporta la presencia de una nueva variante genética de SARS-CoV-2".Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba(in European Spanish).Retrieved25 June2021.
  17. ^"Cuba reports new coronavirus variant amid peak of cases".The Brazilian Report.22 January 2021.Retrieved25 June2021.
  18. ^"Cuba detects South African COVID-19 variant amid virus uptick".Miami Herald.Retrieved25 June2021.
  19. ^Acosta N (22 April 2021)."South African virus variant fuels record Cuban COVID-19 cases".Reuters.Retrieved25 June2021.
  20. ^Dourado E (2020). "Accelerating Availability of Vaccine Candidates for COVID-19".SSRN Electronic Journal.doi:10.2139/ssrn.3564664.ISSN1556-5068.S2CID219394200.
  21. ^"COVID-19: las vacunas cubanas son una" esperanza "para América Latina | DW | 23.06.2021".Deutsche Welle(in European Spanish).Retrieved28 June2021.
  22. ^Más-Bermejo PI, et al. (23 September 2022)."Cuban Abdala vaccine: Effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba; A cohort study".The Lancet Regional Health - Americas.16.doi:10.1016/j.lana.2022.100366.ISSN2667-193X.PMC9507841.PMID36185968.
  23. ^abcdLimonta-Fernández M (2021). "The SARS-CoV-2 receptor-binding domain expressed in Pichia pastoris as a candidate vaccine antigen July 3, 2021".medRxiv10.1101/2021.06.29.21259605v1.
  24. ^"Cuba says it's 'betting it safe' with its own Covid vaccine".NBC News.10 April 2021.Retrieved10 April2021.
  25. ^"Maduro struggles to make his grand vaccine promise".Eminetra.co.uk.2 May 2021. Archived fromthe originalon 16 November 2021.Retrieved3 May2021.
  26. ^"Venezuela producirá la vacuna cubana anticovid Abdala".efe(in Spanish).Retrieved3 May2021.
  27. ^"Venezuela to produce Cuban COVID vaccine: Maduro".Aljazeera.Al Jazeera and news agencies. 12 April 2021.Retrieved23 June2021.We've signed an agreement to produce in our laboratories... two million vaccines a month of the Abdala vaccine... for August, September, approximately,
  28. ^Ministry of Health Vietnam (16 June 2021)."Bộ trưởng Bộ Y tế đàm phán với Cuba về hợp tác sản xuất vaccine".giadinh.net.vn(in Vietnamese).Retrieved17 June2021.
  29. ^"ABDALA Clinical Study".rpcec.sld.cu.Registro Público Cubano de Ensayos Clínicos.Retrieved21 March2021.
  30. ^BioCubaFarma (4 April 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. "".Twitter.Retrieved10 April2021.
  31. ^"Covid Check-in: Cuba's Homegrown Vaccines".AS/COA.5 April 2021.Retrieved10 April2021.
  32. ^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 "".Twitter(in Spanish).Retrieved10 April2021.
  33. ^"Abdala: Comienza tercera dosis en el Oriente cubano".cuba.cu(in Spanish).Retrieved21 April2021.
  34. ^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 ".Twitter.Retrieved21 April2021.
  35. ^Agencia Cubana de Noticias."Convergen múltiples voluntades para éxito de estudio Abdala en Bayamo".ACN(in European Spanish). Archived fromthe originalon 3 May 2021.Retrieved21 April2021.
  36. ^Rodriguez M, Sánchez L (4 May 2021)."With Abdala, Cuba takes another step toward broad scale vaccination".Granma.Retrieved2 July2021.
  37. ^"Evaluation of the safety and immunogenicity of the vaccine candidate" ABDALA "in children and adolescents".rpcec.sld.cu.Registro Público Cubano de Ensayos Clínicos.Retrieved7 July2021.
  38. ^"ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos".rpcec.sld.cu.Retrieved10 April2021.
  39. ^Ministerio de Salud Pública en Cuba."Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba".Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba(in European Spanish).Retrieved23 April2021.
  40. ^"COVID: Cuba approves emergency use of own Abdala vaccine".Deutsche Welle.9 July 2021.Retrieved9 July2021.
  41. ^"Aprueba el CECMED el Autorizo de Uso de Emergencia del candidato vacunal cubano ABDALA | CECMED".cecmed.cu(in Spanish).Retrieved9 July2021.
  42. ^Nga L (18 September 2021)."Vietnam approves emergency use of Cuba's Covid vaccine".VnExpress.Retrieved18 September2021.
  43. ^"Vincentians have access to Cuban Abdala vaccine | Loop Caribbean News".Loop News.Retrieved28 December2021.
  44. ^"SVG receives 300 Abdala vaccines from Cuba".SVG-TV.21 December 2021. Archived fromthe originalon 21 December 2021.Retrieved28 December2021.
  45. ^Garrison C (29 December 2021)."Mexico authorizes Cuban COVID-19 vaccine for emergency use".WTVB.Retrieved29 December2021.
  46. ^"Venezuela announces acquisition of 12 million Cuban vaccine doses".Macau Business.25 June 2021.Retrieved25 June2021.
  47. ^"Venezuela receives first shipment of Cuban coronavirus vaccine".Reuters.24 June 2021.Retrieved25 June2021.
  48. ^"Gov't to purchase 10 million doses of Cuba's COVID-19 vaccine".The Government of Vietnam.20 September 2021.Retrieved26 September2021.
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