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. 2022 Dec:16:100366.
doi: 10.1016/j.lana.2022.100366. Epub 2022 Sep 24.

Cuban Abdala vaccine: Effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba; A cohort study

Pedro I Más-Bermejo  1 , Félix O Dickinson-Meneses  1 , Kenia Almenares-Rodríguez  2 , Lizet Sánchez-Valdés  3 , Raúl Guinovart-Díaz  4 , María Vidal-Ledo  2 , Enrique Galbán-García  5 , Yadira Olivera-Nodarse  6 , Isabel Morgado-Vega  6 , Santiago Dueñas-Carrera  7 , Merardo Pujol  7 , Francisco Hernández-Bernal  7 , Miladys Limonta-Fernández  7 , Gerardo Guillén-Nieto  7 , Verena L Muzio-González  7 , Marta Ayala-Ávila  7
Affiliations

Cuban Abdala vaccine: Effectiveness in preventing severe disease and death from COVID-19 in Havana, Cuba; A cohort study

Pedro I Más-Bermejo et al. Lancet Reg Health Am. 2022 Dec.

Erratum in

Abstract

Background: COVID-19 vaccines have proven safe and efficacious in reducing severe illness and death. Cuban protein subunit vaccine Abdala has shown safety, tolerability and efficacy (92·3% [95% CI: 85·7‒95·8]) against SARS-CoV-2 in clinical trials. This study aimed to estimate Abdala's real-world vaccine effectiveness (VE).

Methods: This retrospective cohort study in Havana analyzed Cuban Ministry of Public Health databases (May 12-August 31, 2021) to assess VE in preventing severe illness and death from COVID-19 (primary outcomes). Cox models accounting for time-varying vaccination status and adjusting by demographics were used to estimate hazard ratios. A subgroup analysis by age group and a sensitivity analysis including a subgroup of tested persons (qRT-PCR) were conducted. Daily cases and deaths were modelled accounting for different VE.

Findings: The study included 1 355 638 persons (Mean age: 49·5 years [SD: 18·2]; 704 932 female [52·0%]; ethnicity data unavailable): 1 324 vaccinated (partially/fully) and 31 433 unvaccinated. Estimated VE against severe illness was 93·3% (95% CI: 92·1-94·3) in partially- vaccinated and 98·2% (95% CI: 97·9-98·5) in fully-vaccinated and against death was 94·1% (95% CI: 92·5-95·4) in partially-vaccinated and 98·7% (95% CI: 98·3-99·0) in fully-vaccinated. VE exceeded 92·0% in all age groups. Daily cases and deaths during the study period corresponded to a VE above 90%, as predicted by models.

Interpretation: The Cuban Abdala protein subunit vaccine was highly effective in preventing severe illness and death from COVID-19 under real-life conditions.

Funding: Cuban Ministry of Public Health. Genetic Engineering and Biotechnology Centre.

Keywords: COVID-19; Cohort studies; Cuba; Effectiveness; SARS-CoV-2; Vaccination; Vaccines.

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Conflict of interest statement

The Public Health Ministry of Cuba guaranteed the payment of the salaries to the authors through their respective institutions. Genetic Engineering and Biotechnology Centre paid for the article processing charges.

Figures

Figure 1
Figure 1
Abdala vaccine effectiveness study participants: eligibility, exposure and outcomes. Havana, Cuba, May 12‒August 31, 2021.
Figure 2
Figure 2
Daily confirmed, actual, and predicted confirmed cases (A) and deaths (B), with and without the Abdala vaccine. Havana, Cuba, July 9‒August 31, 2021.
See this image and copyright information in PMC

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