Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2023 | Month : January | Volume : 17 | Issue : 1 | Page : OC09 - OC12 Full Version

Comparative Study of Outcomes of COVID-19 Infection in Vaccinated and Unvaccinated Patients- A Retrospective Analysis


Published: January 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/56184.17239
Bhaskar Kakarla, Swaroopa Deme, Sugunasree Aakula, Abhilash Naini, Radhika Soanker, Nageswara Rao Modugu, Raju YSN

1. Associate Professor, Department of Pulmonary Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. 2. Associate Professor, Department of Internal Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. 3. Junior Resident, Department of Internal Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. 4. Junior Resident, Department of Internal Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. 5. Additional Professor, Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. 6. Professor and Head, Department of Internal Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. 7. Professor, Department of Internal Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India.

Correspondence Address :
Swaroopa Deme,
Associate Professor, Department of Internal Medicine, Nizams Institute of Medical Sciences, Hyderabad, Telangana, India.
E-mail: swaroopareddymd@gmail.com

Abstract

Introduction: Vaccine development was the highest priority during the Coronavirus disease 2019 (COVID-19) pandemic. An ideal vaccine should decrease the risk of infection and reduce the incidence and severity of the disease. Risk of disease or infection following COVID-19 vaccination needs to be evaluated for its efficacy and effectiveness.

Aim: To compare the severity of the disease, oxygen requirement, and mortality between vaccinated and unvaccinated COVID-19 patients.

Materials and Methods: This retrospective study was done on the data of the patients who were admitted to Nizams Institute of Medical Sciences, Hyderabad, Telangana, India. All the admitted patients with COVID-19 disease, diagnosed by either Reverse Transcriptase Polymerase Chain Reaction (RTPCR) or rapid antigen detection method from April 2021 to October 2021, were included. Parameters recorded were: age, gender, co-morbidities, clinical staging as per institute protocol, vaccination status, oxygen requirement, the requirement of non invasive or invasive ventilation, inflammatory markers like C-Reactive Protein (CRP), ferritin, D dimer, Computed Tomography (CT) severity index, and outcomes.

Results: The mean age of patients was 49.7±14.8 yrs in the unvaccinated group, and 52.75±16.2 yrs in the vaccinated group. Out of 175 patients, 102 (58.28%) were unvaccinated. There were 25 (14.28%) deaths, of which 20 (80%) were unvaccinated and 5 (20%) were vaccinated. Oxygen requirement was more among the unvaccinated 73/96 (76.04%). High flow oxygen/mechanical ventilation requirement was higher in unvaccinated compared to vaccinated, 38 (76%) vs 12 (24%), respectively (p-value <0.005). The mortality rate was higher in unvaccinated patients with co-morbidity, with an odds ratio of 3.32 (1.2-9.3), p-value=0.02. Serum ferritin levels were significantly higher in the unvaccinated group, 858.15±935.5 vs 473.4±663.2 ng/mL, p-value 0.007. CT severity index in the unvaccinated group was 13.82±5.4, and for the vaccinated group, it was 11.58±5.49.

Conclusion: Severe disease, oxygen requirement, and mortality were low in vaccinated patients. Vaccination has also resulted in a statistically significant decrease in mortality in patients with co-morbidities. Serum ferritin levels were also found to be lower in vaccinated patients.

Keywords

Co-morbidities, Coronavirus disease 2019 vaccination, Mortality, Oxygen requirement, Serum ferritin

COVID-19 caused a total of 278 million infections and 5.4 million deaths as of December 26th, 2021 (1). The rapid development of a vaccine became the highest priority because of the faster spread of infection throughout the globe and lead to the development of several types of vaccines using different platforms introduced into the market. Although the ideal vaccine should decrease the infection and disease, as of now vaccine efficacy is measured by its efficacy in decreasing the risk of disease i.e. a successful vaccine should decrease the disease risk by 50% according to the World Health Organisation (WHO)(2). Evidence of decreasing the viral load in the lower respiratory but not upper respiratory tract suggests a possibility of spread of infection despite vaccination and highlights the importance of non pharmacological interventions like using a face mask, social distancing, and hand washing. Antigenic drift, waning antibodies and heterogeneous response to the initial infection decide the durability along with seasonal variations in humidity affecting the spread of the infection necessitating the administration of the vaccine at right time to decide overall vaccine efficacy (3).

Vaccination trials for the prevention of disease started in early 2020. Various platforms have been used for the preparation of vaccines like mRNA, protein subunit-based, vector-based, and inactivated forms have led to the release of good numbers of vaccines into the market. Phase 3 results of mRNA vaccines, both manufactured by Pfizer and Moderna showed good efficacy of 94.1% and 95%, respectively (4). In the real-world experience of healthcare workers, the efficacy of mRNA vaccines was shown to be 90% and 80% after full and partial vaccination (5). India started a vaccination program with Adenovirus vector-based vaccine (ChAd Ox1nCoV-19-Covishield®) for healthcare workers initially in January 2021 followed by an inactivated whole virion vaccine (Covaxin®) subsequently. The incidence of COVID-19 disease or infection following vaccination needs to be tested for its efficacy in the field and also its effectiveness against possible mutant viruses since it can lead to breakthrough infections. In a study done by Keehner J et al., on healthcare workers at the University of California, the positivity rate for breakthrough infections following mRNA vaccines was 0.05% (4). Breakthrough infection after 14 days of the second dose of covishield developed in 13.3% of patients and 16.9% of persons who received any dose of vaccine (6).

In a study by Alexander Underwood, it was found that sustained neutralising IgG response up to 6 months following mild COVID-19 infection and IgA levels dropped (7).

The safety and side-effects of vaccines have been a major concern among the normal population because of various conspiracy theories and misinformation. It was found that the most reliable information was available from health workers and the ministry of health and COVID-19 vaccine acceptance rate was in parallel with a flu vaccination (8). The second dose gives a robust response to the vaccine and the effect declined with time reaching to first dose-response or postcovalescent phase of infection at six months.

Antibody response was found to be negatively associated with age and positively associated with the total score of vaccination side-effects. Memory T cell response to spike protein was seen in 87% of individuals who received the vaccine (9). BNT162b is associated with an increased risk of myocarditis, lymphadenopathy, appendicitis, and zoster infection in a study on the Israeli population (10). This study was aimed to compare the severity of disease, need for oxygen requirement, and mortality in vaccinated and unvaccinated patients.

Material and Methods

This retrospective study was done on the data of the COVID-19 patients who were admitted to Nizams Institute of Medical Sciences, in Hyderabad, Telangana, India from April 2021 to October 2021. Institutional Ethical Committee approval was taken for this study (EC/NIMS/2968/2022).

Inclusion criteria: All the admitted patients with COVID-19 disease, diagnosed by either RTPCR or rapid antigen detection method were included in the study.

Exclusion criteria: Patients who left against medical advice were excluded from the study.

Sample size calculation: The sample size was estimated to be 189 considering the odds ratio to be 0.51, based on a similar study done in the UK. The expected prevalence of severe COVID-19 infection in unvaccinated is 10.7%, and the ratio of vaccinated to unvaccinated as 0.5, with an anticipated relative precision as 70% and confidence interval of 95% (11).

Study Procedure

The data was collected from case records. Clinical staging was based on institutional protocols:

• Mild disease-fever, upper respiratory symptoms, myalgias, headache, anosmia, ageusia, vomiting, diarrhoea,
• Moderate disease -pneumonia with no signs of severe disease, chest X-ray infiltrates involving less than 50% of lung fields, respiratory rate: 24-29/min, SpO2 90-94% on room air, and
• Severe disease-pneumonia with signs of severe disease, chest X-ray infiltrates involving more than 50% of lung fields, RR ≥30/min, SpO2 <90%, multiorgan dysfunction, cytokine storm, and shock (12).

Age, gender, co-morbidities, clinical staging as per institute protocol, oxygen requirement, the requirement of non invasive or invasive ventilation, inflammatory markers like CRP, ferritin, D-dimer, CT severity index, and outcomes: alive or dead. A total of 175 subjects were enrolled in the study.

Statistical Analysis

Statistical analysis was done using Statistical Package for the Social Science (SPSS) software version 17.0 software. Continuous variables were presented as mean and Standard Deviation (SD). The odds ratio was used to calculate the risk of mortality between unvaccinated and vaccinated. Categorical variables were expressed as frequencies and percentages. Nominal categorical data between the groups were compared using the Chi-squared test after the construction of the 2×2 table. For all statistical tests, a p-value less than 0.05 was taken to indicate a significant difference.

Results

In this study, data of 175 patients with COVID-19 infections were included. The data was divided into two groups based on the history of COVID-19 vaccination-unvaccinated and vaccinated; 102 patients were unvaccinated and 73 patients were vaccinated.Among the 73 vaccinated patients, 33 (45.2%) received only one dose of vaccination while the rest 40 (54.8%) completed two doses. The clinical and biochemical characteristics of these patients in each of these groups are shown (Table/Fig 1).

The mean age of the unvaccinated group was 49.7±14.8 yrs, whereas, it was 52.75±16.2 yrs in the vaccinated group. Males constituted 67.42% of the total study group whereas females were 32% of the total; 30.14% of the vaccinated and 33.3% of unvaccinated were females. CT chest was done in 97 patients. CT severity index in the unvaccinated group was 13.82±5.4, whereas for the vaccinated group 11.58±5.49 (p-value of 0.08).

A significantly higher number of unvaccinated patients (52.9%) had a severe disease while 15.68% of the vaccinated had a severe disease. The presence of co-morbidity has led to a statistically significant increase in the mortality of unvaccinated patients (Table/Fig 2). Oxygen requirement (both low flow and high flow/mechanical ventilation) was higher in the unvaccinated group. Overall 80% of the deaths occurred in unvaccinated patients (Table/Fig 3). Unvaccinated patients constituted 3/4th of severe COVID-19 disease.Clinical outcomes between the unvaccinated and vaccinated groups were analysed using the odds ratio. The odds of death, need for oxygen therapy and odds of developing severe COVID-19 infection were found to be significantly higher in the unvaccinated group when compared to the vaccinated group.

The serum CRP was done semi-quantitatively. In the unvaccinated group, of the 90 patients in whom CRP was done, 67% of patients had CRP >24 mg/mL while in the vaccinated group, of the 60 patients in whom CRP was done, 43% of patients had CRP >24 mg/mL.

The serum levels of ferritin and D-Dimer were done in symptomatic cases and were compared between vaccinated and unvaccinated groups using the unpaired T-test. Serum ferritin levels were significantly higher in the unvaccinated group, indicating a higher inflammatory response.

Discussion

The main aim of the study was to compare the severity of the disease, oxygen requirement, and mortality between vaccinated and unvaccinated patients. This study revealed an increase in severe COVID-19, oxygen requirement, and increased mortality in the unvaccinated group. Also, it was observed that there was an increase in serum ferritin levels in the unvaccinated population. Unvaccinated patients with co-morbidities have shown an increase in mortality. The severity of the disease was higher in unvaccinated patients. These findings correlated with a study done by Tenforde MW et al., in which vaccination was associated with a decrease in disease progression and mechanical ventilation or death (13).

The need for oxygen requirement, either high flow or mechanical ventilation was higher in unvaccinated patients. In an Israeli study by Rinott E et al., there was a decrease in the number of vaccinated patients requiring mechanical ventilation comparable to this study (14).

Mortality was found to be significantly higher in the unvaccinated group. This correlated with the study by Alsaffar WA et al., in which a significant reduction in mortality and the complicated course was observed (15).

Co-morbidities observed in this study were: diabetes mellitus, hypertension, cardiac disease, Chronic Kidney Disease (CKD), and chronic pulmonary disease (other than COVID). Diabetes was the most common (52.5%) co-morbidity followed by hypertension (46.6%) which was similar to a study done by Varma M et al. To understand the effect of co-morbidity on poorer outcomes in unvaccinated, compared to the vaccinated group, the odds of overall mortality rate in patients with co-morbidity were assessed (16). There was a statistically significant increase in mortality with OR 3.55 (p-value=0.03) in unvaccinated patients when compared to vaccinated patients. Similar findings were observed in studies by Lechien JR et al., (17), and Bianca de Almeida-Pititto (18). In the former study, pre-existing chronic lung disease, cardiovascular disease, chronic kidney disease, diabetes mellitus, hypertension, obesity (BMI >30) and immunosuppression, sickle cell disease, cancer, age, sex, and pregnancy have been found to predispose to higher intubation rates and death/severity in unvaccinated individuals.

Ali H et al., showed a strong antibody response to COVID-19 vaccination in diabetics although the titres were low when compared to non diabetics. The presence of hypertension did not show any variation in the immune response to COVID-19 vaccination (19). In a study by Sanders JF et al., immune response to COVID-19 vaccination in CKD and dialysis patients was comparable to those without chronic kidney disease (20). Hence, all patients with co-morbidities are advised to receive the vaccination.

Biochemical parameters studied include serum ferritin, CRP, and D dimer. Serum ferritin levels were significantly higher in the unvaccinated population indicating a higher inflammatory response. So far no article 11could be found that compared ferritin levels between vaccinated and unvaccinated COVID-19 patients to the best of our knowledge.

The CT chest was done in 97 patients. CT severity index in the unvaccinated group was higher (13.82±5.4) than in the vaccinated group (11.58±5.49) although statistically not significant (p-value=0.08). In a study by Lee JE et al., proportion of patients without CT pneumonia was significantly higher in a vaccinated group but CT severity scores were not compared between the vaccinated and unvaccinated in their study (21).

Limitation(s)

This is a retrospective analysis done from a single institute.Prospective studies from multiple centres and a higher number of patients are required to substantiate the above findings.

Conclusion

This study has shown that COVID-19 vaccination has a significant impact on decreasing the severity of the disease, the need for high flow oxygen or mechanical ventilation, and mortality, especially in patients with co-morbidities. Unvaccinated patients constituted 3/4th of severe COVID-19 disease. The odds of mortality in unvaccinated patients with co-morbidity were observed to be 3.55 (1.1-11.4; p=0.03). Most of the deaths (80%) in this study occurred in unvaccinated patients. Serum ferritin levels were significantly lower in vaccinated individuals. Head-to-head comparison between similar vaccines (i.e between mRNA vaccines ) and efficacy against different variants of COVID-19 is needed.

References

1.
http://COVID19.who.int/accessed on 26/12/2021. 2021
2.
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DOI and Others

DOI: 10.7860/JCDR/2023/56184.17239

Date of Submission: Mar 08, 2022
Date of Peer Review: May 11, 2022
Date of Acceptance: Sep 20, 2022
Date of Publishing: Jan 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? NA
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Mar 22, 2022
• Manual Googling: Sep 13, 2022
• iThenticate Software: Sep 19, 2022 (4%)

ETYMOLOGY: Author Origin

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