ABDALA
CIGB-66, is a COVID-19 vaccine
Cuba says Abdala vaccine 92.28% effective against coronavirus
The announcement came just days after the government said another homegrown vaccine, Soberana 2, has proved to be 62% effective with just two of its three doses.
- June 22, 2021, 10:03 IST
Havana: Cuba said on Monday that its three-shot Abdala vaccine against the coronavirus has been proved 92.28% effective in last-stage clinical trials.
The announcement came just days after the government said another homegrown vaccine, Soberana 2, has proved to be 62% effective with just two of its three doses.
“Hit by the pandemic, our scientists at the Finlay Institute and Center for Genetic Engineering and Biotechnology have risen above all the obstacles and given us two very effective vaccines,” President Miguel Diaz-Canel tweeted.
The announcement came from state-run biopharmaceutical corporation BioCubaFarma, which oversees Finlay, the maker of Soberana 2, and the Center for Genetic Engineering and Biotechnology, the producer of Abdala.
Both vaccines are expected to be granted emergency authority by local regulators shortly.
Cuba, whose biotech sector has exported vaccines for decades, has five coronavirus vaccine candidates.
The Caribbean’s largest island is facing its worst Covid-19 outbreak since the start of the pandemic following the arrival of more contagious variants, setting new records for daily coronavirus cases.
The Communist-run country has opted not to import foreign vaccines but to rely on its own. Some experts said it was a risky bet but it appears to have paid off, putting Cuba in position to burnish its scientific reputation, generate much-needed hard currency through exports and strengthen the vaccination drive worldwide.
Several countries from Argentina and Jamaica to Mexico, Vietnam and Venezuela have expressed an interest in buying Cuba’s vaccines. Iran started producing Soberana 2 earlier this year as part of late-phase clinical trials.
Cuba’s authorities have already started administering the experimental vaccines en masse as part of “intervention studies” they hope will slow the spread of the virus.
About a million of the country’s 11.2 million residents have been fully vaccinated to date.
Daily cases have halved in the capital, Havana, since the start of the vaccination campaign a month ago, using Abdala, according to official data.
Cuba has reported a total of 169,365 Covid-19 cases and 1,170 deaths.
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.
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.[16]
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.[17]
Efficacy
From May 3, the efficacy of the vaccine will start being evaluated.[18][19][20]
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.[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
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]
References
- ^ “ABDALA Clinical Study – Phase III”. rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
- ^ “ABDALA Clinical Study”. rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
- ^ 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. Retrieved 31 March 2021.
- ^ “MAMBISA Study”. rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
- ^ “Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III”. http://www.bioworld.com. Retrieved 10 April 2021.
- ^ “Cuba’s Abdala COVID-19 vaccine enters phase 3 clinical trial – Xinhua | English.news.cn”. http://www.xinhuanet.com. Retrieved 10 April 2021.
- ^ Zimmer C, Corum J, Wee SL. “Coronavirus Vaccine Tracker”. The New York Times. ISSN 0362-4331. Retrieved 10 April 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”. http://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.
- ^ “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.
- ^ “Scientists announce Abdala’s administration of 3rd dose will finish”. http://www.plenglish.com/index.php?o=rn&id=66941&SEO=scientists-announce-abdalas-administration-of-3rd-dose-will-finish (in Spanish). Retrieved 2 May 2021.
- ^ Noticias, Agencia Cubana de. “Concluye aplicación de vacuna Abdala en Oriente de Cuba”. ACN (in Spanish). Retrieved 2 May2021.
- ^ “Cuba conclui ensaios clínicos de candidata a vacina contra covid-19”. R7.com (in Portuguese). 2 May 2021. Retrieved 2 May2021.
- ^ “Abdala cerca de concluir la fase III de ensayos clínicos; Mambisa se alista para avanzar a nueva fase (+Video)”. Granma.cu (in Spanish). Retrieved 3 May 2021.
- ^ “Cuba says it’s ‘betting it safe’ with its own Covid vaccine”. NBC News. Retrieved 10 April 2021.
- ^ “Maduro struggles to make his grand vaccine promise”. Eminetra.co.uk. 2 May 2021. Retrieved 3 May 2021.
- ^ “Venezuela producirá la vacuna cubana anticovid Abdala”. http://www.efe.com (in Spanish). Retrieved 3 May 2021.
- ^ Apr 11, Reuters /; 2021; Ist, 16:27. “Indonesian President orders Java rescue efforts after quake kills 8 – Times of India”. The Times of India. Retrieved 3 May 2021.
- ^ 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.
External links
 | Scholia has a profile for Abdala (Q106390652). |
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Other names | ABDALA |
| Routes of administration | Intramuscular |
| Part of a series on the |
| COVID-19 pandemic |
|---|
| COVID-19 (disease)SARS-CoV-2 virus (variants) |
| showTimeline |
| showLocations |
| showInternational response |
| showMedical response |
| showImpact |
| COVID-19 portal |
//ABDALA, CUBA, CIGB-66, COVID-19, vaccine, CORONA VIRUS, SARS-CoV-2,
