Affiliation:
1. Biomedical Research and Therapeutic Vaccines Institute
2. “Dr. Luis Razetti” University Hospital
3. Venezuelan Scientific Research Institute, Altos de Pipe
4. Central University of Venezuela
5. University Hospital of Caracas
Abstract
Abstract
Background
While rigorous randomized clinical trials have substantiated the efficacy of COVID-19 vaccines in reducing hospitalization and mortality rates, there is a paucity of post-authorization analyses conducted in real-world settings. In Venezuela, the primary vaccines administered are Sinopharm and Sputnik-V. However, the performance and effectiveness of these vaccines within this specific population remain to be thoroughly investigated.
Methods
A prospective cohort study was undertaken from October 5, 2021, to March 31, 2022, across four sentinel hospitals in Venezuela. The outcomes were evaluated at two time points: day 28 and day 48, utilizing the WHO’s COVID-19 Clinical Progression Scale. For the purpose of analysis, patients were classified into two groups: vaccinated and unvaccinated.
Results
The study included a total of 175 patients, of which 85 (48.6%) were categorized as vaccinated, with the majority (76.5%) having received two doses. The median age of the patients was 68 years, with a slight predominance of females (53.1%), and the majority being unemployed/retired (60.6%). Hypertension (53.1%) and diabetes (18.3%) were the most prevalent comorbidities. The median Charlson index of the patients was 3 points, with no statistically significant differences observed between the groups (p = 0.2). Upon admission, dyspnea was more commonly observed in unvaccinated patients compared to vaccinated patients (76.7% vs. 62.4%, p = 0.039). Almost all laboratory parameters were comparable in both groups, with the exception of the median D-dimer level, which was significantly higher in unvaccinated patients (7.6 vs. 1.4 µg/mL, p = 0.015). A total of 50 patients (28.6%) died of the disease, with a higher proportion of deaths observed in unvaccinated patients compared to vaccinated patients (35.6% vs. 21.2%, p = 0.035). Factors such as advanced age (OR = 1.043, 95%CI = 1.015–1.071, p = 0.002) were associated with increased odds of death, while factors such as vaccination against COVID-19 (OR = 0.428, 95%CI = 0.185–0.99, p = 0.047), high oxygen saturation (OR = 0.964, 95%CI = 0.934–0.995, p = 0.024), and enoxaparin administration (OR = 0.292, 95%CI = 0.093–0.917, p = 0.035) were associated with decreased odds of death.
Conclusion
In the course of the third and fourth waves of the pandemic, vaccination against COVID-19 was found to be associated with a 57% reduction in mortality among patients treated in four public hospitals in Venezuela.
Publisher
Research Square Platform LLC
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