Abdala (vaccine)
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]
This article is about the Cuban vaccine. For other uses, see Abdala.Vaccine description
ABDALA
- Full and emergency authorizations
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.
Vaccine design[edit]
The vaccine was designed by researchers from the Center for Genetic Engineering and Biotechnology and has been described in a pre-print submission.[22] 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.[22] 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.[22] 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.[22]
Manufacturing[edit]
Venezuela has claimed that it will manufacture the vaccine[23] but, as of 2 May 2021, this claim had not yet materialised.[24] State-owned EspromedBIO will manufacture the vaccine but some "arrangements" are needed to start production.[25] In April, Nicolás Maduro said that a capacity of 2 million doses per month is hoped to be reached by August or September 2021.[26] 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.[27]
History[edit]
Clinical trials[edit]
In July 2020, Abdala commenced phase I/II clinical trials.[28]
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,[29][30] and second doses started being administered from April 5.[31] Third doses have started being administered on 19 April[32][33][34] and on May 1, adherence to the three-dose protocol was over 97%.[35]
In July 2021, Abdala started clinical trial phase I/II for children and adolescents aged 3-18.[36]
Economics[edit]
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".[45] The first shipment of Abdala arrived in Venezuela the day following this announcement.[46]
On 20 September, 2021, The Vietnamese Government has issued a resolution on purchase of 10 million doses of Abdala COVID-19 vaccine.[47]