Original Article www.ghanamedj.org Volume 57 Number 4 December 2023 Copyright © The Author(s). This is an Open Access article under the CC BY license. 293 Comparative analysis of clinical characteristics of COVID-19 among vaccinated and unvaccinated patients in a major treatment facility in Ghana Benedict NL Calys-Tagoe1,3, Joseph Oliver-Commey2, Georgia NK Ghartey3, Abdul G. Mohammed3, Delia Bandoh3, Christian Owoo2,4, and Ernest Kenu3,5 Ghana Med J 2023; 57(2): 293-299 doi: http://dx.doi.org/10.4314/gmj.v57i4.6 1Department of Community Health, University of Ghana Medical School, Korle Bu, Accra 2Ghana Infectious Disease Centre, Ga East, Accra 3Ghana Field Epidemiology and Laboratory Training Programme 4Department of Anaesthesia, University of Ghana Medical School, Korle Bu, Accra 5Department of Epidemiology and Disease Control, University of Ghana School of Public Health, Legon, Accra Corresponding author: Christian Owoo E-mail: cowoo@ug.edu.gh Conflict of interest: None declared. SUMMARY Objectives: To compare clinical characteristics of COVID-19 among vaccinated and unvaccinated patients in a major treatment facility in Ghana. Design: A retrospective study drawing on data from COVID-19 patients’ records visiting the facility from March 2021 to December 2021. Setting: Ghana Infectious Disease Centre, Ga East Municipality, Greater Accra Region, Ghana. Participants: In-patients and outpatients who reported to the facility from 1st March 2021 to December 2021 were included in the study, and patients with missing data on vaccination were excluded. Outcome measures: underlying conditions, symptoms, case management information, hospital service rendered (OPD, HDU or ICU), length of hospital stay, treatment outcome Results: The study included 775 patient records comprising 615 OPD and 160 hospitalised cases. Less than one-third (26.25%; 42) of the patients hospitalised were vaccinated compared to almost 40.0% (39.02%; 240) of the patients seen at the OPD. Vaccinated individuals were nearly three times (aOR = 2.72, 95%CI:1.74-4.25) more likely to be managed on an outpatient basis as compared to the unvaccinated. The death rate among the vaccinated group and the unvaccinated were (0.71%; 2) and (3.45%; 17), respectively, with a significant reduction in the risk of dying among the vaccinated compared to the unvaccinated (aOR = 0.13, 95%CI: 0.028 0.554). Conclusions: Less than half of the in-patient and OPD patients were vaccinated. Mild infections, fewer days of hos- pitalisation, outpatient treatment and higher chances of survival were associated with being vaccinated against SARS- CoV-2. Prudent measures should be implemented to encourage the general public to take up SARS-CoV-2 vaccines. Keywords: SARS-CoV-2, vaccination status, Ghana, COVID-19, COVAX, GIDC, Ga East Funding: None declared INTRODUCTION As of May 20th, 2022, the Corona Virus Disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV 2) had led to about 522 million infections and 6 million deaths world- wide.1 Since the index case was reported in Ghana in March 2020, the country has recorded about 161,000 cases, resulting in about 1,500 deaths.2 About 4 billion people in the world have been fully vac- cinated with the various types of COVID-19 vaccine since the vaccines were first rolled out in December 2020.3 As of May 18th, 2022, 6 million persons in Ghana had been fully vaccinated via the COVID-19 Vaccines Global Access (COVAX) initiative.2,4,5 This notwithstanding, the COVID-19 vaccination cover- age in the country is relatively lower than the WHO im- munisation target rate of 70% of the country's total pop- ulation.2,6 Also, a study on vaccine hesitancy reported that approximately 40.7% of Ghanaians were reluctant to receive the vaccine, with concerns about its efficacy, side effects and association with infertility.7 Studies have shown the association of vaccination with reducing mor- bidity and mortality rates and disease severity in other parts of the world.8–10 http://www.ghanamedj.org/ http://dx.doi.org/10.4314/gmj.v57i4.6 mailto:cowoo@ug.edu.gh Original Article www.ghanamedj.org Volume 57 Number 4 December 2023 Copyright © The Author(s). This is an Open Access article under the CC BY license. 294 However, there is still a dearth of information and docu- mentation of the disease’s clinical characteristics among vaccinated and non-vaccinated, specific to the Ghanaian population. This study aimed to compare the clinical characteristics of COVID-19 (including the resulting se- verity of disease) among vaccinated and unvaccinated patients in a major treatment facility in Ghana. METHODS Study Design: We conducted a retrospective study among COVID-19 cases reporting to the Ghana Infec- tious Disease Center, Ga East. Data on both COVID-19 in-patients and outpatients from March 2021 to Decem- ber 2021 were obtained from the health facility. Study Setting: The Ghana Infectious Disease Center (GIDC) is a 100-bed capacity facility located in the Ga East Municipality of the Greater Accra Region. The GIDC was commissioned on July 24th, 2020, to serve as a National Case Management Coordinating Treatment Centre for the clinical management of COVID-19 and, eventually, other infectious diseases. The facility runs an Outpatient Department (OPD) and a Post-COVID-19 Clinic, with the capacity to admit patients to its High De- pendency (HDU) and Intensive Care Units (ICU). The clinical staff of the centre includes an infectious disease specialist, an anaesthesiologist/intensivist, 15 medical of- ficers, 40 nurses, and 13 laboratory personnel. As of May 2022, 1004 walk-in (OPD) cases and 317 admissions have been attended at the treatment centre. However, only patients who reported to the facility after vaccina- tion against COVID-19 had begun in the country -after 1st March 2021, were included in this study. Data collection: Data on COVID-19 patients reporting to the GIDC (Outpatient clinic and Admission wards) from March 2021 to December 2021 was extracted from patient folders using a digital abstraction form on the KoboCollect version 2021.2.4 platform. All patients with missing data on vaccination were excluded from the study. Data Variables: Data extracted for analysis comprised demographic information (age, sex, occupation, marital status and residence), epidemiologic information (travel history, epidemiological links), clinical information (vi- tal signs, underlying conditions, symptoms, case man- agement information, hospital service rendered (OPD, HDU or ICU), length of hospital stay if admitted and treatment outcome). Also, data were extracted on pa- tients’ COVID-19 vaccination (status, vaccine type, and regimen completion). Fully vaccinated patients were de- fined as those with a full series of any COVID-19 vaccine at least 7 days before hospitalisation. Partially vaccinated were those with an incomplete series of any COVID-19 vaccine, and unvaccinated were those with no COVID- 19 vaccine.11 Disease severity information was also ab- stracted from patient folders. Cases were classified as mild, moderate, severe or critical based on the WHO cri- teria for classifying COVID-19 cases.12 Data analysis: The data extracted were cleaned and im- ported into StataIC 15 (StataCorp, College Station, TX, USA) for analysis. Categorical variables were expressed as frequencies and percentages with their corresponding 95% CI. Parametric continuous variables were expressed as means and standard deviation. The chi-square test of association and ANOVA were used to compare the clin- ical characteristics of the vaccinated and unvaccinated patients. Binary logistic regression analysis was per- formed to test the association between vaccination status and the various clinical characteristics. Variables signifi- cant at a P-value < 0.25 at the unadjusted level were se- lected and fitted into an adjusted logistic model. The P- value < 0.25 used in the adjusted model allowed for the inclusion of more explanatory variables in the adjusted model. The level of significance for the final model was set at 5%. Ethical considerations Ethical clearance for this study was sought from the Ghana Health Service Ethics Review Committee (GHS- ERC 006/05/20). The administration of the GIDC for- mally granted permissions. Throughout the data abstrac- tion and analysis, generated codes were used in place of personal identifiers of patients to ensure patient anonym- ity and preserve confidentiality. Individual patient con- sent was not obtained for the study as the data was ac- cessed retrospectively and strictly anonymised. RESULTS Characteristics of the Patients Studied A total of 856 patient records were available, of which 81 had missing information on vaccination status and were thus excluded from the analysis. Hence, analysis was done on 775 patient records comprising 615 OPD and 160 hospitalised cases. The median age of in-patients was 55.0 (IQR 36.0 – 67.0) years. Most hospitalised patients were males (51.88%; 83), whilst most patients attended to at the OPD were females (55.61%; 324). More than half (60.63%; 97) of the patients admitted had co-mor- bidities, whilst less than one-third(25.05%; 154) of those attended to at the OPD were with co-morbidities. On the severity and outcome of the infection, almost two-thirds (62.50%; 100) of the patients admitted were severely or critically ill, while none of the patients seen at OPD had a severe or critical illness. Almost 12% (11.88%; 19) of the patients admitted and managed died compared to zero mortality recorded among the patients seen at OPD. Re- garding the vaccination status among the patients, less http://www.ghanamedj.org/ Original Article www.ghanamedj.org Volume 57 Number 4 December 2023 Copyright © The Author(s). This is an Open Access article under the CC BY license. 295 than one-third (26.25%; 42) of the patients hospitalised were vaccinated against COVID-19, while almost 40.0% (39.02%; 240) of the patients seen at the OPD were vac- cinated (Table 1). Table 1 Characteristics of study participants Characteristics In-Patient Outpatient n (%) n (%) Sex Female 77 (48.12) 342 (55.61) Male 83 (51.88) 273 (44.39) Age (median; IQR) years 55.0 (IQR 36.0 – 67.0) 33.0 (IQR 26.0 – 44.0) <25 years 14 (8.75) 121 (19.67) 25 – 34 years 19 (11.88) 208 (33.82) 35 – 44 years 24 (15.00) 133 (21.63) 45 – 54 years 21 (13.12) 76 (12.36) 55+ years 82 (51.25) 77 (12.52) Marital status Single 29 (18.13) 134 (21.79) Married 54 (33.75) 168 (27.32) Not stated** 77 (48.12) 348 (56.59) Co-morbidity No 63 (39.37) 496 (80.65) Yes 97 (60.63) 154 (25.05) Hospitalisation care High Dependency Unit 147 (91.88) - Intensive Care Unit 13 (8.12) - Initial severity of disease Mild 26 (16.25) 582 (94.63) Moderate 34 (21.25) 33 (5.37) Severe/Critical 100 (62.50) 0 (0.00) Median Length of Hospitalization 16.00 days (IQR 10.00 – 24.00) - Treatment outcome Alive 141 (88.12) 615 (100.00) Dead 19 (11.88) 0 (0.00) Vaccination status Unvaccinated 118 (73.75) 375 (60.98) Vaccinated 42 (26.25) 240 (39.02) Vaccination completion Partial 28 (66.67) 174 (72.50) Complete 14 (33.33) 66 (27.50) Reported Type of vaccine AstraZeneca 17 (40.48) 150 (62.50) J&J 2 (4.76) 21 (8.75) Pfizer 3 (7.14) 14 (5.83) Not stated** 20 (47.62) 55 (22.92) IQR: Interquartile Range; n: absolute numbers. Distribution of COVID-19 infection and Vaccination status among patientsMore than half of all those in- fected with COVID-19 (54%) and those vaccinated (57%) were females. The 25 – 34 age group was the most affected (29.29%; 227) and the most vaccinated (31.56%; 89). (Table 2). Table 2 Distribution of COVID-19 infection and Vac- cination among patients Variables COVID 19 infection Vaccinated n (%) n (%) Sex Female 419 (54.06) 161 (57.09) Male 356 (45.94) 121 (42.91) Age <25 years 135 (17.42) 29 (10.28) 25 – 34 years 227 (29.29) 89 (31.56) 35 – 44 years 157 (20.26) 56 (19.86) 45 – 54 years 97 (12.52) 34 (12.06) 55+ years 159 (20.52) 74 (26.24) Marital status Single 163 (42.34) 41 (31.30) Married 222 (57.66) 90 (68.70) Co-morbidity No 468 (65.09) 158 (60.77) Yes 251 (34.91) 102 (39.23) n: absolute numbers Association between vaccination status and clinical presentation among COVID-19 patients A multivariate logistic regression analysis revealed a sta- tistically significant association between case category, length of hospitalisation, care setting, treatment outcome and vaccination status. Vaccinated individuals were nearly three times (aOR = 2.72, 95%CI:1.74-4.25) more likely to be managed on an outpatient basis as compared to the unvaccinated. The death rate among the vaccinated group and the un- vaccinated were (0.71%; 2) and (3.45%; 17), respec- tively, with a significant reduction in the risk of dying among the vaccinated compared to the unvaccinated (aOR = 0.13, 95%CI: 0.028-0.554). Compared to unvac- cinated patients, those vaccinated had reduced severe dis- ease states (6.38% vs 16.63%). However, the severity of the disease was not significantly associated with vaccina- tion status (Table 3). Table 3 Association between vaccination status and clinical presentation among COVID-19 patients Variables Unvaccinated n(%) Vaccinated n(%) cOR (95%CI) aOR (95%CI) Case category In-patient 118 (23.94) 42 (14.89) Ref Ref OPD 375 (76.06) 240 (85.11) 1.80 (1.220 - 2.650) 2.72 (1.740 - 4.250) Disease severity Mild 372 (75.46) 236 (83.69) Ref Ref Moderate 39 (7.91) 28 (9.93) 1.19 (0.701 - 2.005) 0.79 (0.453 - 1.390) Severe/Critical 82 (16.63) 18 (6.38) 0.35 (0.203 - 0.593) 0.18 (0.098 - 0.322) Care Setting http://www.ghanamedj.org/ Original Article www.ghanamedj.org Volume 57 Number 4 December 2023 Copyright © The Author(s). This is an Open Access article under the CC BY license. 296 High Dependency Unit/ Inten- sive Care Units 118 (23.94) 42 (14.89) Ref Ref Home treatment 375 (76.06) 240 (85.11) 1.90 (1.2736 - 2.844) 2.80 (1.802-4.354) Median Length of Stay in the Hospital 22.52 (±12.705) 8.07 (±5.048) 0.68 (0.598 -0.783) 0.68 (0.590-0.781) Treatment Outcome Alive 476 (96.55) 280 (99.29) Ref Ref Death 17 (3.45) 2 (0.71) 0.21 (0.048 - 0.915) 0.13 (0.028- 0.554) cOR: Crude Odds Ratio; aOR: Adjusted Odds Ratio; CI: Confidence Interval; Ref: Reference; n: absolute numbers Association between vaccination status and patient- reported symptoms among COVID-19 patients Patient data with missing vaccination status were ex- cluded from the analysis of the reported symptoms. Re- garding patient-reported symptoms, the loss of taste (14.15% vs 76.08%), dyspnoea (13.16% vs 90.91%), loss of smell (17.17% vs 27.00%) and chest pains (29.03% vs 88.10%) were all reduced in the vaccinated group com- pared to the unvaccinated. A multivariable logistic re- gression analysis controlling for age, sex, marital status, occupation, and co-morbidities revealed a statistically significant association between patients’ vaccination sta- tus and various symptoms such as loss of taste, dyspnoea, palpitations, insomnia, chest pains and loss of smell. The odds of palpitation report among those vaccinated was reduced by 98% compared to the unvaccinated (aOR = 0.02, 95%CI: 0.006 0.038). The study also revealed a 94% reduction in the odds of loss of taste reported among those vaccinated compared to their counterparts (aOR = 0.06, 95%CI: 0.027 0.154). There was also a 91% reduc- tion in the odds of dyspnoea among the vaccinated group compared to the unvaccinated (aOR = 0.09, 95%CI: 0.028 0.271) (Table 4). Table 4 Association between vaccination status and patient-reported clinical symptoms among COVID-19 patients Variables Unvaccinated Vaccinated cOR (95%CI) aOR (95%CI) n (%) n (%) Fever No 233 (66.76%) 156 (74.64%) Ref Ref Yes 116 (33.24%) 53 (25.36%) 0.68(0.465-1.001) 0.41 (0.106-1.599) Loss of Taste No 100 (23.92%) 176 (85.85%) Ref Ref Yes 318 (76.08%) 29 (14.15%) 0.05(0.033- 0.081) 0.06 (0.027-0.154) Cough No 152 (40.97%) 83 (37.56%) Ref Ref Yes 219 (59.03%) 138 (62.44%) 1.15 (0.820- 1.624) 1.55 (0.831-2.888) Dizziness No 176 (76.86%) 98 (80.33%) Ref Ref Yes 53 (23.14%) 24 (19.67%) 0.81 (0.473- 1.398) 1.37 (0.627-2.970) Dyspnoea No 35 (9.09%) 99 (86.84%) Ref Ref Yes 350 (90.91%) 15 (13.16%) 0.02 (0.008- 0 .029) 0.09 (0.028-0.271) Palpitations No 18 (5.54%) 38 (76.00%) Ref Ref Yes 307 (94.46%) 12 (24.00%) 0.02(0.008-0.041) 0.02 (0.006-0.038) Fatigue No 152 (59.14%) 102 (65.38%) Ref Ref Yes 105 (40.86%) 54 (34.62%) 0.77(0.507-1.158) 0.83 (0.361-1.915) Headache No 144 (49.15%) 77 (46.39%) Ref Ref Yes 149 (50.85%) 89 (53.61%) 1.12 (0.763-1.635) 1.37 (0.652-2.879) Myalgia No 93 (62.84%) 56 (56.57%) Ref Ref Yes 55 (37.16%) 43 (43.43%) 1.30 (0.773-2.181) 1.32 (0.622-2.803) Insomnia No 58 (16.76%) 65 (87.84%) Ref Ref Yes 288 (83.24%) 9 (12.16%) 0.03(0.013-0.059) 0.20 (0.004-0.093) Loss of Smell No 219 (73.00%) 164 (82.83%) Ref Ref Yes 81 (27.00%) 34 (17.17%) 0.56 (0.358-0.878) 0.35 (0.136-0.912) Chest pain No 55 (11.90%) 154 (70.97%) Ref Ref Yes 407 (88.10%) 63 (29.03%) 0.06 (0.037-0.083) 0.05 (0.027-0.094) cOR: Crude Odds Ratio; aOR: Adjusted Odds Ratio; CI: Confidence Interval; Ref: Reference; n: absolute numbers http://www.ghanamedj.org/ Original Article www.ghanamedj.org Volume 57 Number 4 December 2023 Copyright © The Author(s). This is an Open Access article under the CC BY license. 297 DISCUSSION In the global fight against the COVID-19 pandemic, vac- cination has been reported to impact infection severity and disease outcomes in countries where vaccines have been introduced. This study compared the clinical char- acteristics of COVID-19 among vaccinated and unvac- cinated patients at the GIDC in a bid to contribute to stud- ying the significance of vaccination against COVID-19 in the Ghanaian setting, For hospitalised and OPD cases reviewed in this study, more than 60% of the patients who presented with the in- fection had not been vaccinated as of December 2021. This is similar to the findings of other studies that indi- cate that the fewer vaccinated cases are due to heightened immunity and reduced susceptibility to the infection in individuals, which is offered by vaccination.13–16 Our study differs from other studies where cases were higher among vaccinated people because of breakthrough infec- tions after vaccination and underlying conditions.17,18 It is worth noting that many of the vaccinated patients had been vaccinated with AstraZeneca, a double-dose course vaccine. This vaccine was the first to be received in Ghana and has been the most used for vaccination against COVID-19 in the country so far.19 In this study, more than half of patients who had been vaccinated had not un- dertaken the full vaccination regimen, as was seen in other studies where it was found that low vaccine sup- plies, hesitancy and lack of adequate information on vac- cination schedule influenced incompleteness.20,21 Studies have shown that some form of protection was offered to individuals, whether partially or fully vaccinated.22 From this study, being vaccinated decreased the odds of requiring admission to high-dependency or intensive care units for severe disease. The Appropriateness Evaluation Protocol (AEP) confirms that the hospital service re- ceived by a patient indicates disease severity, with OPD cases having a less severe form of the disease.23 Hence, this study’s finding is similar to others where vaccination was seen to reduce hospitalisation rates, explained based on the elicited immune response after vaccination.22,24,25 In this same vein, being vaccinated decreased the odds of dependency on hospital care (HDU/ICU) when an indi- vidual was down with the disease because the severity in such patients was lower compared to patients who had not been vaccinated. However, in countries with much higher coverage, there were larger numbers of vaccinated patients with higher disease severity because the base population at risk of being infected largely included al- ready vaccinated people.26 This study manifests that vac- cination decreased the odds of lengthy admission days among patients who had been admitted. This could be due to the relatively faster resolution of pa- tients’ symptoms and reduced need for specialised care and organ support, as a similar Norway study showed.27 However, in another study, there was no significant dif- ference between the length of hospital stay among vac- cinated and unvaccinated patients, which was said to have been influenced by the fact that the patients being studied were geriatric and had common underlying con- ditions.28 In addition, this study further demonstrates that being vaccinated decreased the odds of death among pa- tients on admission, suggesting reduced disease severity and its associated indicators among vaccinated patients. Our study reports reduced odds of reporting ageusia, dyspnoea, palpitations, insomnia, anosmia and chest pain among vaccinated patients compared to those who had not been vaccinated. Among these symptoms are palpita- tions, insomnia and dyspnoea, which are indicators of higher severity of the disease.29 However, there was no significant difference in the reporting of fever, cough, dizziness, fatigue, headache symptoms, and myalgia, which are much milder symptoms present in both vac- cinated and unvaccinated patients.29 Though using data from a single facility in this study could be a limitation for generalising our findings, this centre is currently the only infectious disease centre in the country and receives referrals from other treatment centres. Therefore, the findings in this study are seem- ingly essential in telling the Ghanaian story. CONCLUSION Less than half of both the in-patient and OPD patients were vaccinated. Mild infections, fewer days of hospital- isation, outpatient treatment and higher chances of sur- vival were associated with being vaccinated against SARS-CoV-2. Also, there were reduced odds of report- ing ageusia, dyspnoea, palpitations, insomnia, anosmia and chest pain among vaccinated patients compared to those who had not been vaccinated. These findings sup- port the claim that vaccination against COVID-19 re- duces disease severity and the risk of dying. Therefore, prudent measures should be implemented to encourage the general public to take up SARS-CoV-2 vaccines. ACKNOWLEDGEMENT The authors wish to express their profound gratitude to the management of the Ghana Infectious Disease Centre, Ga East, Accra, for allowing access to the data that was used in this study. http://www.ghanamedj.org/ Original Article www.ghanamedj.org Volume 57 Number 4 December 2023 Copyright © The Author(s). This is an Open Access article under the CC BY license. 298 REFERENCES 1. World Health Organisation. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int/. Published 2022. Accessed May 22, 2022. 2. Ghana Health Service. 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