The Lancet Regional Health. Americas (Dec 2022)

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

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

Journal volume & issue
Vol. 16
p. 100366

Abstract

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Summary: 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.

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