Open Access Original

Article DOI: 10.7759/cureus.45638

Vaccination Can Prevent Severe Pulmonary

Disease in COVID-19 Positive Patients: A Case-
Review began 08/25/2023
Control Study
Review ended 09/14/2023
Published 09/20/2023 Sreesupria Ravichandran 1 , Keerthika Vijayakumar 2 , Vishwajit G. V. 2 , Siva P. M. 3

© Copyright 2023
Ravichandran et al. This is an open access 1. Community Medicine, Government ESIC Medical College, Coimbatore, IND 2. Community Medicine, Coimbatore
article distributed under the terms of the Medical College, Coimbatore, IND 3. Community Medicine, Government Medical College, Tiruppur, IND
Creative Commons Attribution License CC-
BY 4.0., which permits unrestricted use,
Corresponding author: Siva P. M., [email protected]
distribution, and reproduction in any
medium, provided the original author and
source are credited.

Abstract
Background: The COVID-19 pandemic was a global health emergency, which brought lives to a standstill. To
combat this deadly virus, two vaccines were deployed widely: COVISHIELD (ChAdOx1 nCoV-19) and
COVAXIN (BBV152). These were approved based on the immunological response they elicit in standardized
conditions; however, the real-life scenario after deployment was completely different. Only in such
situations can the true effectiveness of vaccines be assessed. The primary objective was to assess
the effectiveness (VE) of COVAXIN/COVISHIELD in preventing severe pulmonary disease in RT-PCR-
positive COVID-19 patients greater than 18 years of age.

Materials and methods: A case-control study was conducted among 260 subjects aged above 18 years,
positive for COVID-19 through RT-PCR. 130 cases and 130 controls were enrolled. Radiological findings
were obtained and subjects with >50% lung involvement were considered as cases. Subjects were interviewed
about their vaccination status. Odds ratio was calculated, and the adjusted odds ratio was estimated for
vaccine effectiveness, using the formula (1-adjusted ODDS ratio)*100.

Results: The vaccine effectiveness for a single dose of vaccine was 55.2% (95% C.I. 11.0%-77.5%) and with
two doses was 98.0% (95% C.I. 85.0%-99.7%). Hence two doses are highly effective than a single dose of
vaccine in reducing lung involvement.

Conclusion: Two doses of vaccine are more effective than a single dose vaccine in reducing lung
involvement. Since sporadic cases of COVID-19 still persist, it is important to emphasize the role of
vaccination in preventing severe COVID-19 infections, particularly in the elderly and those with
comorbidities.

Categories: Infectious Disease, Public Health, Epidemiology/Public Health

Keywords: vaccine effectiveness, pulmonary involvement, covaxin, covishield, covid-19

Introduction
The COVID-19 pandemic was a global health emergency, which had brought our lives to a standstill. As of
July 2023, COVID-19 has affected over 768 million people around the globe, with nearly seven million deaths
[1]. In India, over 44 million people have been affected, with over 531,903 deaths [2].

Widespread vaccination drives were launched in many countries to combat this deadly virus. The
vaccination drive in India had a promising start on January 16, 2021, with a gradual fall thereafter. The
reason for this fall could have been multifactorial- probably due to negligence about the vaccine, being
afraid to get the vaccine, lack of information and awareness about the safety of the vaccine, and lack of
production and supply of the suitable vaccine candidate suitable to local needs, vaccine hesitancy.
Complacency, distrust, lack of communication, and fear of side effects had aggravated this problem [3].

In India, there were predominantly two vaccines widely deployed in the vaccination drive: COVISHIELD
(ChAdOx1 nCoV- 19) vaccine is a recombinant, replication-deficient adenoviral vector ChAdOx1, containing
the SARS-CoV-2 spike glycoprotein antigen, developed by the Serum Institute of India Pvt. Ltd.,
manufactured under technology transfer from Oxford/Astrazeneca, and India's indigenous BBV152, a whole-
virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770), manufactured by Bharat Biotech, developed
in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV),
commonly called COVAXIN [4,5]. These vaccines were approved based on the immunological response they
elicit, as evaluated from clinical trials, where the testing conditions were standardized, in a specific
population thus providing key points that were required for vaccine licensure. However, the real-world
scenario after vaccine deployment was entirely different, and only in such conditions, can the true
protective effect of vaccines be assessed.

How to cite this article

Ravichandran S, Vijayakumar K, G. V. V, et al. (September 20, 2023) Vaccination Can Prevent Severe Pulmonary Disease in COVID-19 Positive
Patients: A Case-Control Study. Cureus 15(9): e45638. DOI 10.7759/cureus.45638
 Although significant developments have been made in terms of treatment and prevention of COVID-19,
vulnerable members of the population such as the elderly and high-risk individuals are still susceptible [6].
Transmission of the virus may be blocked by vaccination of younger age groups, but overall mortality can be
reduced only if vaccination confers direct protective effects in vulnerable groups [7]. Ruch et al. studied the
use of CT-imaging as a predictor of severe disease (early death/ICU admission) in COVID-19 patients and
patients with lung involvement >50% were more likely to develop early severe disease, making lung
involvement of disease an important prognostic factor [8].

Case-control studies are generally used to assess the effectiveness of vaccines after their implementation in
public health programs by using endpoints of diseases like lung involvement [9]. Hence, post-vaccination
evaluations are important means of providing information about prevention of disease endpoints like lung
involvement and mortality. The main objective of our study is to estimate the vaccine effectiveness (VE) of
BBV152 (COVAXIN)/ChAdOx1 nCoV-19 Vaccine (COVISHIELD) in reducing the severity of pulmonary
involvement in patients with COVID-19 infection.

Materials And Methods

This is a hospital-based, single-center, retrospective case-control study conducted at a tertiary care center
in Tamil Nadu with the data obtained from August 2022 to January 2023. The study population included
hospitalized COVID-19 cases, confirmed by RT-PCR, above 18 years of age, with CT scans taken in the
Radiology Department.

The cases were “people aged above 18 years who are RT-PCR positive for COVID-19 virus with severe
pulmonary involvement (Lung involvement greater than 50%).” The controls were “people aged above 18
years who are RT-PCR positive for COVID-19 virus with mild pulmonary involvement (Lung involvement less
than or equal to 50%, including nil Lung involvement).”

Inclusion criteria
Patients who were willing to participate in the study, who had been tested RT-PCR positive for COVID-19
infection with CT-chest taken.

Exclusion criteria
Pre-existing lung diseases, including previous COVID-19 infection, patients with inconclusive CT findings,
and critically ill patients who were not able to provide details. Considering the vaccination status in cases as
40% and controls as 60%, with a 95% confidence interval and 80% power, the sample size was estimated as
100 cases and 100 controls. The case-control ratio was taken as 1:1. Total of 130 cases and 130 controls were
enrolled, and all were included in the analysis.

Procedure
After getting clearance from the Institutional Ethical Committee (EC Reg No. ECR/892/Inst/TN/2016; Ref no:
0579/2021) and approval from the Department of Radiology, the RT-PCR-positive COVID-19 cases were
enrolled. Data were collected by consecutive sampling. Study subjects were chosen from the list of COVID-
19-positive patients provided by the Radiology Department. Consent was obtained from each participant. CT
scan report of each participant was collected from the radiology department, and they were classified as
cases (>50% lung involvement) and controls (<=50% lung involvement). Individual subjects were contacted
to collect details regarding their demographics, vaccination status, and comorbidities (Diabetes,
Hypertension, Coronary Artery Disease, Chronic kidney disease, and Chronic liver disease). The data
collected were kept confidential.

Statistical analysis
Data were collected and entered in MS Excel, and analysis was done using the SPSS 21.0 version (IBM Corp.,
Armonk, NY). A chi-square test was done to find out the association between categorical variables. The
crude ODDS ratio was calculated using univariate crosstabulation, and the adjusted ODDS ratio was
calculated using Multiple logistic regression after adjusting with covariates (Age > 50 years, comorbidity,
occupation status, and vaccine doses) and then VE was estimated from adjusted ODDS ratio, using the
formula (1-adjusted ODDS ratio)*100. A p-value of less than 0.05 was considered significant. A p-value of
less than 0.20 was included in the logistic regression analysis, performed using the “Enter Method.” Recall
bias may have been present, but the data collected was cross-checked with the vaccine certificate of each
individual to ensure reliability.

Results
As seen in Table 1, most of the subjects were in the age group of above 50 years (cases - 67.7% vs controls -
60.0%), male gender (cases - 50.8% vs controls - 51.5%), and urban background (cases - 70.8% vs controls -
70.8%). Most of the patients were unemployed (cases - 50.0% vs controls - 49.2%) since the predominant age
group was above 50 years. Comorbidities were present in 65.4% of cases and 56.9% of controls. Regarding

2023 Ravichandran et al. Cureus 15(9): e45638. DOI 10.7759/cureus.45638 2 of 7

 the hospital admission status, 83.8% of cases and 86.2% of controls were admitted in wards with oxygen
support. Only 16.2% vs 13.8% were admitted in intensive care units. There was no significant difference
noted between any of the above-mentioned factors with cases and controls.

Cases Controls Chi-square test

Variables
N % N % ODDS ratio (95% C.I.) P-value

>50 years 88 67.7% 78 60.0%

Age group 1.397 (0.840 – 2.322) 0.197
< =50 years 42 32.3% 52 40.0%

Male 66 50.8% 67 51.5%

Gender 0.970 (0.596 – 1.577) 0.901
Female 64 49.2% 63 48.5%

Semiprofessional 2 1.5% 9 6.9%

Skilled 26 20.0% 34 26.2%

Occupation Semiskilled 13 10.0% 9 6.9% NA 0.064

Unskilled 24 18.5% 14 10.8%

Unemployed 65 50.0% 64 49.2%

Rural 38 29.2% 38 29.2%

Residence 1.000 (0.586 – 1.707) 1.000
Urban 92 70.8% 92 70.8%

Present 85 65.4% 74 56.9%

Comorbidity 1.429 (0.866 – 2.359) 0.162
Absent 45 34.6% 56 43.1%

ICU 21 16.2% 18 13.8%

Place of admission 1.199 (0.606 – 2.372) 0.602
Ward 109 83.8% 112 86.2%

TABLE 1: Distribution of study subjects according to their socio-demographic profile among

cases and controls
NA - Not Applicable

Out of the total 130 cases only 19 (14.6%) received the COVID-19 vaccine and out of 130 controls 59 (45.4%)
received the COVID-19 vaccine, as seen in Table 2. The crude odds ratio was 0.206 (95% C.I. 0.113%-0.374%,
p<0.001). Regarding the type of vaccine, out of 19 vaccinated cases, all of them took the Covishield vaccine
and in 59 vaccinated controls 53 received Covishield and six received Covaxin.

2023 Ravichandran et al. Cureus 15(9): e45638. DOI 10.7759/cureus.45638 3 of 7

 Cases Controls Chi-square test
Vaccination status
N % N % ODDS ratio (95% C.I.) P-value

Vaccinated 19 14.6 59 45.4

Not vaccinated 111 85.4 71 54.6 0.206 (0.113 – 0.374) <0.001

Total 130 100.0 130 100.0

Covishield 19 14.6 53 40.8 0.229 (0.125 – 0.419) <0.001

Covaxin 0 0.0 6 4.6 NA 0.003

Not Vaccinated 111 85.4 71 54.6 Ref -

Total 130 100.0 130 100.0 - -

TABLE 2: Association between vaccination status and lung involvement

NA - Not Applicable, Ref - Reference

Regarding the number of doses of vaccine received, out of 19 vaccinated cases 18 had only a single dose and
only one patient received two doses of vaccine. Out of 59 vaccinated controls 28 received a single dose and
31 received two doses. The crude ODDS ratio for a single dose compared to unvaccinated was 0.41 (95% C.I.
0.21 - 0.80, p=0.008), and for two doses 0.02 (95% C.I. 0.003%-0.155%, p<0.001), which is shown in Table 3.

Cases Controls Chi-square test

Number of doses
N % N % ODDS ratio (95% C.I.) P-value

Two doses 1 0.8 31 23.8 0.021 (0.003 – 0.155) <0.001

One dose 18 13.8 28 21.5 0.411 (0.212 – 0.798) 0.008

Not Vaccinated 111 85.4 71 54.6 Ref -

Total 130 100.0 130 100.0 - -

TABLE 3: Association between number of doses and lung involvement

Ref - Reference

To estimate the VE, covariates with a p-value<0.20 for crude OR were selected for multiple logistic regression
to get the adjusted odds ratio. The covariates included in the logistic regression analysis were age group,
occupation, and comorbid status, and along with that vaccination status was included. After doing
regression analysis the adjusted ODDS ratio was estimated as 0.214 (95% C.I. 0.116%-0.396%, p<0.001), as
seen in Table 4. The VE ((1-adjusted ODDS ratio)*100) was estimated to be 78.6% (95% C.I. 60.4%-88.4%),
which shows that vaccination has a protective effect over severe lung involvement.

2023 Ravichandran et al. Cureus 15(9): e45638. DOI 10.7759/cureus.45638 4 of 7

 95% C.I.for EXP(B)
Variables B S.E. Sig. Exp(B)
Lower Upper

Age >50 years 0.297 0.298 0.319 1.346 0.750 2.416

Presence of any comorbidity 0.109 0.282 0.700 1.115 0.642 1.935

Occupation - Unemployed - - 0.179 - - -

Semiprofessional -1.169 0.848 0.168 0.311 0.059 1.637

Skilled -0.132 0.349 0.706 0.877 0.443 1.737

Semiskilled 0.283 0.510 0.579 1.327 0.489 3.603

Unskilled 0.716 0.414 0.084 2.046 0.908 4.609

Vaccinated -1.542 o.314 <0.001 0.214 0.116 0.396

Constant 0.122 0.364 0.738 1.130 - -

TABLE 4: Multiple logistic regression to estimate the effectiveness of vaccination

B - Beta Coefficient, S.E - Standard Error, Sig - Significance, Exp(B) - Adjusted odds ratio, C.I. - Confidence Interval

While doing regression analysis with vaccination dosage the adjusted ODDS ratio for a single dose was 0.448
(95% C.I. 0.225%-0.890%, p=0.022), and for two doses was 0.020 (95% C.I. 0.003%-0.150%, p<0.001), as seen
in Table 5. So, the effectiveness of a single dose of vaccine was 55.2% (95% C.I. 11.0%-77.5%), and with two
doses was 98.0% (95% C.I. 85.0%-99.7%).

95% C.I.for EXP(B)

Variables B S.E. Sig. Exp(B)
Lower Upper

Age >50 years 0.313 0.311 0.315 1.367 0.743 2.515

Presence of any comorbidity 0.196 0.287 0.493 1.217 0.694 2.134

Unemployed - - 0.148 - - -

Semiprofessional -1.243 0.843 0.140 0.289 0.055 1.505

Skilled -0.097 0.359 0.786 0.907 0.449 1.833

Semiskilled 0.285 0.515 0.580 1.330 0.485 3.648

Unskilled 0.803 0.443 0.070 2.232 0.937 5.317

Vaccine Doses – Not Vaccinated - - 0.000 - - -

Single dose -0.803 0.351 0.022 0.448 0.225 0.890

Two doses -3.927 1.036 <0.001 0.020 0.003 0.150

Constant 0.039 0.372 0.915 1.040 - -

TABLE 5: Multiple logistic regression to estimate the effectiveness of number of doses of vaccine
B - Beta Coefficient, S.E - Standard Error, Sig - Significance, Exp(B) - Adjusted odds ratio, C.I. - Confidence Interval

Discussion
Vulnerable populations have been the worst affected by the COVID-19 pandemic, which includes people
living in poverty, the elderly, people with disabilities, and racial and ethnic minorities [10]. Despite WHO
declaring the end of the pandemic, members of these groups continue to suffer from the risk of COVID-19-
related mortality and morbidity. As stressed by the WHO, it is important to transition to the long-term

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 management of the COVID-19 infection, where vaccinations will continue to play a vital role [11].

Li et al. have found that there was no significant association between age distribution and the group that
had more severe CT changes (p = 0.074) [12]. Similarly, in our study, we found no significant difference in
the age distribution of cases and controls (67.7% of cases and 60% of the controls were greater than 50 years
old). This further supports the notion that age may not be a determining factor in the observed changes.

In the same study [12], male gender was significantly associated with the group that had higher lung
consolidation on CT (p=0.019). But our study showed no significant difference in gender
(p=0.901). Comorbidities were present in 65.4% of cases and 56.9% of controls, with hypertension and
diabetes being the most common, and the severity of disease is higher among this group of patients. This is
similar to a study by Sharma et al. [13], where comorbidities were present in 28.6% of people, with
hypertension and diabetes being the most common and these individuals presented with increased disease
incidence and severity.

In our study, 14.6% of cases (severe lung involvement) and 45.4% (mild lung involvement) of controls had
received at least a single dose. The crude odds ratio of 0.206 indicates the protective effect of vaccination
against severe lung involvement among controls. A previous study by Lee et al. has explored in detail the
imaging and clinical features of COVID-19 breakthrough infections, which also showed that vaccinated
patients had a lower risk of COVID-19 pneumonia and intensive care unit admission [14].

Guan et al. said that interstitial abnormalities seen on CT on admission were significantly correlated with
the patients' endpoints, such as discharge, intensive care unit admission, and mechanical ventilation [15].
These findings were supported by Ruch et al., who found that >50% of lung involvement was associated with
early severe disease (ICU admission/death). Hence, by vaccination, the survival outcome of COVID-19
patients can be improved, by preventing ICU admission and death [8].

The overall VE in our study was estimated at 78.6%. The effectiveness of a single dose of vaccine was 55.2%
and with two doses was 98.0%. This is in concordance with the meta-analysis by Zhang et al., which showed
that multiple vaccinations in the elderly proved to be more effective. This also supported the use of booster
doses to improve immunity [16].

With the emergence of different variants of the virus, such as the delta and omicron variants, there is a high
possibility of a drop in vaccine efficacy. Paul et al. conducted a case-control study in Scotland, where the
efficacy of the ChAdOx1 vaccine against severe Delta variant COVID-19 waned substantially in 20 weeks
from the second dose. The emergence of the Delta variant caused a temporary increase in relative risk in
patients who had only received a single dose, while the relative risk remained unchanged for those who had
received two doses [17]. Andrews et al. showed that double-dose vaccination with ChAdOx1 nCoV-
19 conferred no protection against the Omicron variant 20 weeks post-vaccination [18]. A study conducted
in AIIMS, Bhuvaneshwar, found COVAXIN (BBV152) to have low efficacy against preventing breakthrough
infections [19]. While the above studies have analyzed the vaccine's ability to prevent infections, they have
not looked into its ability to prevent severe lung involvement as a specific endpoint. But a study by ICMR
shows that BBV152 has 69% efficacy in preventing severe infections. By using severe pulmonary
involvement (lung involvement > 50%) as an outcome measure, we have kept ascertainment bias to the
minimum. The efficacy of the vaccine against hospitalization may be underestimated if its efficacy against
test-positive infection is lower than the efficacy against the disease [8]. Hence, in our case-control study, we
have only evaluated the efficacy of the vaccine against severe pulmonary involvement among hospitalized
patients.

A limitation of our study is that we have considered both Covishield and Covaxin under the same umbrella of
vaccination and have not made a distinction in their efficacy. Moreover, we did not perform genomic
sequencing of the virus to accurately determine the infective strain. When the study was being conducted,
both the Omicron and Delta variant were predominant in Tamil Nadu. A study by Wong et al. stated that the
maximum severity of chest radiographic changes peaked at around six to 11 days from symptom onset. As
the CT in our hospital was taken immediately on admission, this time frame of six to 11 days from symptom
onset might not have coincided [20].

Conclusions
The overall efficacy of vaccination against COVID-19 is 78.6%, using the severity of lung involvement as the
primary outcome. Preventing severe lung involvement can significantly reduce morbidity and mortality by
decreasing the need for oxygen supplementation, ICU admission, and the risk of early death. Two doses of
vaccination significantly improve efficacy compared to one, and hence, all people, especially vulnerable
groups like the elderly should be urged to complete their double dose of vaccination. However, more research
has to be done on waning immunity after two doses of vaccination, thus examining the importance of
booster doses.

In conclusion, our study highlights the impact of the COVID-19 pandemic on vulnerable populations,

2023 Ravichandran et al. Cureus 15(9): e45638. DOI 10.7759/cureus.45638 6 of 7

 emphasizing the critical role of vaccinations in its long-term management. It is imperative that we remain
vigilant and adaptable in our strategies, as new variants of COVID-19, including recently identified ones like
EG.5 (Eris), continue to emerge. By drawing lessons from the past years, we can protect ourselves against
these evolving threats.

Additional Information
Disclosures
Human subjects: Consent was obtained or waived by all participants in this study. Institutional Human
Ethics Committee, Coimbatore Medical College, Coimbatore issued approval 0579/2021. Animal subjects:
All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest:
In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services
info: All authors have declared that no financial support was received from any organization for the
submitted work. Financial relationships: All authors have declared that they have no financial
relationships at present or within the previous three years with any organizations that might have an
interest in the submitted work. Other relationships: All authors have declared that there are no other
relationships or activities that could appear to have influenced the submitted work.

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