|Vaccine type||Protein subunit|
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Abdala, technical name CIGB-66, is a COVID-19 vaccine developed by the Center for Genetic Engineering and Biotechnology in Cuba. 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. The full results of the clinical trial have not yet been published. This candidate followed a previous one called CIGB-669 (MAMBISA).
The vaccine was administered in 3 doses spaced 2 weeks apart.
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 at preventing symptomatic COVID-19. 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.
The measure of efficacy includes the initial strain of SARS-COV-2 as well as variants that were present in Cuba during the study, including Alpha, Beta, and Gamma strains. The Beta variant entered Cuba in January 2021 and became the predominant strain in Cuba, fuelling a rise in COVID cases.
As of 28 June 2021, Cuba has not yet released detailed information about the vaccine to the WHO or to the general public via a pre-print or a scientific article. It is planned to do so after the Cuba Health Agency (CECMED) authorises the vaccine for emergency use.
Venezuela has claimed that it will manufacture the vaccine but, as of 2 May 2021, this claim had not yet materialised. State-owned EspromedBIO will manufacture the vaccine but some "arrangements" are needed to start production. In April, Nicolás Maduro said that a capacity of 2 million doses per month is hoped to be reached by August or September 2021. 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.
In July 2020, Abdala commenced phase I/II clinical trials.
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, and second doses started being administered from April 5. Third doses have started being administered on 19 April and on May 1, adherence to the three-dose protocol was over 97%.
In July 2021, Abdala started clinical trial phase I/II for children and adolescents aged 3-18.
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.
On 18 September 2021, Abdala was approved for an emergency use authorization in Vietnam.
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". The first shipment of Abdala arrived in Venezuela the day following this announcement.
On 20 September, 2021, The Vietnamese Government has issued a resolution on purchase of 10 million doses of Abdala COVID-19 vaccine.
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- "ABDALA Clinical Study - Phase III". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
- "Cuba says Abdala vaccine 92.28% effective against coronavirus". Reuters. 21 June 2021. Retrieved 25 June 2021.
- Augustin, Ed (22 June 2021). "Cuba reports a high success rate for its homegrown Abdala vaccine". The New York Times. ISSN 0362-4331. Retrieved 25 June 2021.
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- Welle (www.dw.com), Deutsche. "COVID-19: las vacunas cubanas son una "esperanza" para América Latina | DW | 23.06.2021". DW.COM (in Spanish). Retrieved 28 June 2021.
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- "Venezuela producirá la vacuna cubana anticovid Abdala". www.efe.com (in Spanish). Retrieved 3 May 2021.
- "Venezuela to produce Cuban COVID vaccine: Maduro". Aljazeera.com. Al Jazeera and news agencies. 12 April 2021. Retrieved 23 June 2021.
We've signed an agreement to produce in our laboratories… two million vaccines a month of the Abdala vaccine… for August, September, approximately,
- 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). Retrieved 17 June 2021.
- "ABDALA Clinical Study". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 21 March 2021.
- 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. Retrieved 10 April 2021.
- "Covid Check-in: Cuba's Homegrown Vaccines". AS/COA. Retrieved 10 April 2021.
- 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). Retrieved 10 April 2021.
- "Two Cuban Vaccines Start Second Dose Phase III Trials". Kawsachun News. 5 April 2021. Retrieved 10 April 2021.
- "Abdala: Comienza tercera dosis en el Oriente cubano". www.cuba.cu (in Spanish). Retrieved 21 April 2021.
- 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. Retrieved 21 April 2021.
- Noticias, Agencia Cubana de. "Convergen múltiples voluntades para éxito de estudio Abdala en Bayamo". ACN (in Spanish). Retrieved 21 April 2021.
- Rodriguez, Maby; Sánchez, Liz (4 May 2021). "With Abdala, Cuba takes another step toward broad scale vaccination". Granma. Retrieved 2 July 2021.
- "Evaluation of the safety and immunogenicity of the vaccine candidate "ABDALA" in children and adolescents". rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 7 July 2021.
- "ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos". rpcec.sld.cu. Retrieved 10 April 2021.
- 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 Spanish). Retrieved 23 April 2021.
- "COVID: Cuba approves emergency use of own Abdala vaccine". Deutsche Welle. 9 July 2021. Retrieved 9 July 2021.
- "Aprueba el CECMED el Autorizo de Uso de Emergencia del candidato vacunal cubano ABDALA | CECMED". www.cecmed.cu (in Spanish). Retrieved 9 July 2021.
- Nga, Le (18 September 2021). "Vietnam approves emergency use of Cuba's Covid vaccine". VnExpress. Retrieved 18 September 2021.
- "Venezuela announces acquisition of 12 million Cuban vaccine doses". Macau Business. 25 June 2021. Retrieved 25 June 2021.
- "Venezuela receives first shipment of Cuban coronavirus vaccine". Reuters. 24 June 2021. Retrieved 25 June 2021.
- "Gov't to purchase 10 million doses of Cuba's COVID-19 vaccine". The Goverment of Vietnam. 20 September 2021. Retrieved 26 September 2021.
|Scholia has a profile for Abdala (Q106390652).|