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SARS-CoV-2 VACCİNATİON STATUS İN SEVERE COVID-19 PATİENTS

Dr.Zehra Beştepe Dursun1, Dr. Hilal Sipahioğlu2, Dr. Musa Göksu1, Dr. Tuğba Bulut3,Dr. Serhat Koyuncu4, Dr. Esma Saatçi5, Dr. İlhami Çelik1

1Health Science University, Kayseri Faculty of Medicine, Department of Infectious Diseases, Kayseri, Turkey.
2Health Science University, Kayseri Faculty of Medicine, Department of Intensive Care Unit, Kayseri, Turkey.
3Infection Control Committee, Kayseri Faculty of Medicine, Health Science University, Kayseri, Turkey.
4Health Science University, Kayseri Faculty of Medicine, Department of Emergency Medicine, Kayseri, Turkey.
5Health Science University, Kayseri Faculty of Medicine, Department of Microbiology, Kayseri, Turkey

*Corresponding author

Dr.Zehra Beştepe Dursun, Health Science University, Kayseri Faculty of Medicine, Department of Infectious Diseases, Kayseri, Turkey.

Abstract

Coronavirus 2019 (COVID-19) is a viral disease with rapidly becoming a pandemic. The disease is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is transmitted more quickly than other viruses and causes a pandemic. Vaccination is the most effective way to control the pandemic. In this study, we analyzed the previous COVID-19 vaccination status of COVID-19 patients admitted to the intensive care unit between July, August, and September 2021. A total of 820 COVID-19 cases were included. 639 (77,9 %) patients had comorbidities. 56 (n=460) percent of the patients had been COVID-19 vaccinated at least once. Four hundred twenty-two patients (51,5 %) were vaccinated with Coronovac, and 55 were vaccinated with Pfizer-BioNTech. Unfortunately, 544 (66,3 %) of the patients died. There was a significant difference in COVID-19 vaccination history, comorbidities, and age years between the surviving and dead groups.

The number vaccinated with Sinovac and Pfizer-BioNTech was higher in the dead group. The duration of the last dose of Sinovac was higher in dead patients than in survived patients. In the Sinovac group, two and three doses of vaccinated patients were elderly. The mortality rate of two doses of vaccinated patients was higher than the others. In the Pfizer- BioNTech group, the duration time of the last dose of vaccination was higher, and the mortality rate was lower in the two-dose vaccinated patients. According to the binary logistics regression analyses, age, comorbidity, and vaccination status were associated with mortality. The severe COVID-19 patients, age, and comorbidities were independent risk factors affecting mortality.

Introduction

Coronavirus disease 2019 (COVID-19) began on March 13, 2022, rapidly becoming a pandemic with over 455 million confirmed cases, and over 6 million deaths have been reported to WHO; at that time, more than 10 billion vaccine doses have been administered worldwide (1). SARS-CoV-2 is transmitted more quickly than other viruses. The isolation and physical measures have successfully limited the spread of the disease. However, these methods are not enough to prevent the disease. In this case, the need for vaccines is increasing. Vaccination is the most effective way to control the pandemic (2, 3). This need for a vaccine emerging with the spread of the COVID-19 pandemic has required rapid action in vaccine studies and resulted in the development of vaccines in an unprecedentedly short timeframe (1). After the COVID-19 pandemic, vaccines were developed in a few types: mRNA, vector, and inactivated. BNT162b2 mRNA (Pfizer-BioNTech) and whole inactivated virus (CoronaVac) vaccines have been recommended according to the clinical trials (4, 5). Turkey is one of the most influenced countries by the pandemic period. The vaccination schedule began with CoronaVac in January 2021 in Turkey (6). A multicenter study of vaccination of hospitalized COVID-19 patients in Turkey reported that unvaccinated patients accounted for the largest group of patients in August 2021 (7). The pandemic is a large-scale outbreak of infectious disease that we learn as our knowledge increases and prevention of the disease. Therefore, data on the real-world effects of COVID-19 vaccines are needed (5). Therefore, this study aimed to investigate the vaccination status of hospitalized COVID-19 patients in the ICU and examine the relation to severe diseases of COVID-19.

Material-Method

Patients and study design

This study was retrospective and conducted in a tertiary referral hospital with a total capacity of 1617 beds in the Central Anatolia region. Adult patients were included in the study who were diagnosed with COVID-19 and hospitalized in the ICU between July, August, and September 2021.

The patient's age, sex, need for mechanical ventilation, mortality, and vaccination status were recorded from the electronic hospital and the government vaccine tracking system.

COVID-19 was diagnosed using the positive real-time polymerase chain reaction (PCR) (Bioeksen, Turkey) tests for SARS-CoV-2.

ICU Hospitalization criteria

The severe or critical COVID-19 cases were diagnosed according to the NIH disease severity categories. Severe cases were classified that have clinical signs of pneumonia (fever, cough, dyspnea, and fast breathing) plus respiratory rate >30 breaths/minute or SpO2<90% on room air. Also, critical cases were diagnosed that have acute respiratory distress syndrome (ARDS), septic shock, and multiple organ dysfunction (8). All the severe or critical illness cases were followed in the ICU. In addition, the patients recorded who were vaccinated with Sinovac (inactivated virus) or BioNTech (mRNA) within 14 days before hospitalization.

The patients were classified into their vaccination status: 0: Unvaccinated, 1: One dose of Sinovac, 2: Two doses of Sinovac, 3: Three doses of Sinovac, 4: One dose of BioNTech, 5: Two doses of BioNTech.

Statistical analysis

Statistical analysis was performed using IBM SPSS for Windows, Version 22.0. (IBM Corp. Armonk, NY: USA. 2013). The Shapiro-Wilk test was used for the normality analysis of the parametric data. Numerical variables were specified as mean ± SD and median (min, max). Comparisons between data groups with a normal distribution were performed using Student's t-test. The comparisons between data groups that did not show a normal distribution were performed using the Mann-Whitney U test. A value of p ≤ 0.05 was considered statistically significant.

Ethics: The authors confirm that the Ethics Committee for Non-Invasive Clinical Research at the xxxx City Hospital (2021-12/560) gave ethics approval for the study.

Result

A total of 820 COVID-19-confirmed cases who were admitted to the ICU were analyzed. All the patients were severe COVID-19 cases. Demographic information on the study population is provided in Table 1. The mean age was 68,1±16,7, and 50 percent of the patients were male. Six hundred thirty-nine (77,9 %) patients had comorbidity. The most common comorbidities were hypertension (33,9 %), diabetes mellitus (26 %), and chronic obstructive pulmonary disease (16,3%), respectively. In addition, 56 (n=460) percent of the patients were COVID-19 vaccinated at least once. Four hundred twenty-two of the patients (51,5 %) were vaccinated with Coronovac (one dose 5 %, two doses 40 %, three doses 6,7%), 55 of the patients (7) were vaccinated with Pfizer-BioNTech (one dose 5 %), two doses 1 %, three doses no one). The time between the last dose of Sinovac and hospitalization was 137,7±53,5, and Pfizer-BioNTech was 50,14±36,1. 18 (2,2%) of the patients were vaccinated with both agents. Five hundred forty-four patients (66,3 %) died.

The comparisons of demographic findings of survived and dead patients are listed in Table 1. No significant difference between groups was observed in gender. However, the mean age of dead patients (72±14,7 years) was higher than survived patients (60,3±17,8 years) (p<0,001).

The dead patients had higher numbers of comorbidity (especially chronic renal failure and malignity) than survived patients (81,4 % vs. 71%, p< 0,001). There was a statistically significant difference in vaccination history between the survived and dead groups (40,9 % vs. 64,3 %, p < 0.001). The history of two doses with Sinovac and one dose with Pfizer- BioNTech vaccinated was higher in the dead group (36% vs. 58,6 %, p<0,001).

The time between the last dose of Sinovac and hospitalization was higher in dead patients than in survived patients (125,7±53,7 vs. 141±53, p=0,012). However, the time between the last dose of Pfizer- BioNTech and hospitalization and mortality were similar between the dead and survived patients.

In the Sinovac group, the mean age of patients was 72,5 ± 13; all vaccinated with two and three doses vaccinated were elderly from the one dose (74,9 ± 12,1). The mortality of two doses of vaccinated patients was higher than the others. The patients with two and three-dose vaccinations had more comorbidity than one-dose vaccinated patients. The time between the last dose of Sinovac and hospitalization was higher in two-dose vaccinated patients (150±42 vs. 112±65, p<0,001).

In the Pfizer- BioNTech group, the patients' mean age and number of comorbidity was similar (63,6±16,1). However, the time between the last dose of Sinovac and hospitalization was higher in two vaccinated patients (150 ± 42 vs. 112 ± 65, p<0,001), although the mortality of these two vaccinated patients was lower than one vaccinated.

Table 1: Demographic characteristics, co-morbidities, and vaccine status.

 Table 2: Demographics of the patients with Sinovac vaccinated.

Table 3: Demographics of the patients, vaccinated with of Pfizer- BioNTech.

Table 4: Univariate binary logistics regression analysis of mortality.

DISCUSSION

This study was conducted to determine the status of the COVID-19 vaccine among severe COVID-19 patients in the ICU. In addition, demographic findings, comorbidity, and survey were reviewed for vaccinated and non-vaccinated in the ICU. Turkey became one of the countries most affected by the pandemic and experienced global waves.During the early pandemic period, social restrictions controlled the first peaks. In Turkey, inactivated vaccines (Sinovac) began in the third wave in January 2021.The second dose of Sinovac was used one month after the first dose. As a result, during the third peak, Turkey's number of vaccinated people was limited (9). In our study, the percent of 56 of the patients had at least one dose of the COVID-19 vaccine. The result was similar to the study in our country. During the study period, the country's vaccination status was nearly 41-61,8 % (10). The Pfizer- BioNTech vaccine was added as an option in mid-April 2021. After then, the third dose of Sinovac was offered, especially to healthcare workers and people>50 years. Most people chose Pfizer- BioNTech after two doses of Sinovac. By January 9, 2023, nearly 5 billion people had received at least one dose and a total dose of COVID vaccines (1). In this study, 51 percent of the patients were vaccinated with Sinovac, 7 percent with Pfizer- BioNTech, and 2,2 percent with two. The duration between the last dose of Sinovac and hospitalization was more than four months. The rate of vaccination status was higher in the dead patients. In addition, dead patients were older than surviving patients. The high mortality rates may be due to old age and the longer interval between the last dose of vaccine and hospitalization. Cook et al. reported the same results as our study: vaccination reduced admission to the intensive care unit by 51 % in patients aged 60-70, whereas 21 % in patients aged 70-80 (11). According to the phase two study of Wu et al., seroconversion and geometric mean titer (GMT) of neutralizing antibodies to live SARS-CoV-2 were found to be considerably lower in patients aged 70 years and older than in patients of other ages (12). In our study, the average age of patients who received Sinovac was over 70, which may have caused the vaccine's efficacy to be low. Wong et al. showed that the duration between the first and second doses of the Sinovac vaccine did not reduce mortality and hospitalization (13). In our study, the mortality rate in the group vaccinated with three doses of Sinovac was lower (46%) than in the group vaccinated with two doses of Sinovac. The reason for this may be the long interval between the last dose of vaccine and hospitalization in the two-dose vaccinated groups. In Turkey, a study reported the same results as ours; the mortality rate was 82.9% in those vaccinated with two doses of Sinovac and 47.1% in those vaccinated with three doses. This result shows that the last vaccination and hospitalization duration was an average of six months for those who received two doses of Sinovac (14). In this study, the patient's age was high for all the ICU patients, and they had more comorbidity. As a result, the mortality rate was 66 %, although the average age of patients and comorbidity were independent risk factors. Another hospital study reported the same mortality rates and risk factors (15). In our study, the patients vaccinated with Pfizer-BioNTech had low mortality rates. In this group, the patients were younger than the Sinovac group. In addition, the last vaccination time and hospitalization duration were shorter than the other groups. Therefore, the mortality rate in the vaccinated with Pfizer-BioNTech may be due to the young people and the time of the vaccination.

Conclusion

As a result, we showed that the vaccine did not reduce mortality in COVID-19 patients hospitalized in the intensive care unit. In addition, the older patients with more comorbidity were independent risk factors affecting mortality.

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