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 Table of Contents  
ORIGINAL ARTICLES
Year : 2021  |  Volume : 9  |  Issue : 3  |  Page : 107-112

Clinical profile of post-vaccination COVID-19-positive patients


1 Seven Hills Dedicated Covid Hospital, Mumbai, India
2 Department of Community Medicine, HBTMC and Dr RN Cooper Hospital, Mumbai, Maharashtra, India
3 Seven Hills Dedicated Covid Hospital, Mumbai, India; Department of Community Medicine, HBTMC and Dr RN Cooper Hospital, Mumbai, Maharashtra, India

Date of Submission24-Jul-2021
Date of Decision08-Jan-2022
Date of Acceptance28-Oct-2021
Date of Web Publication11-May-2022

Correspondence Address:
Smita S Chavhan
Department of Community Medicine, HBTMC and Dr RN Cooper Hospital Mumbai, U 15, Bhaktivedanta Swami Road, JVPD Scheme, Juhu, Mumbai, Maharashtra 400056
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/dypj.dypj_44_21

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  Abstract 

Background: Government of India launched the National COVID Vaccination Program with two vaccines, BBV152 (Covaxin) and AZD1222-ChAdOx1-S (Covishield). Both these vaccines have shown an efficacy of 78% and 63.1%, respectively, in clinical trials. It is evident that there still will be post-vaccination COVID-19-positive patients. However, there are no data regarding the severity and clinical profile of these vaccines in real world scenario. Hence, through this study, we aimed to assess clinical profile of patients of COVID-19 post-vaccination and evaluate the severity of the disease. Materials and Methods: This hospital-based cross-sectional study was done in a dedicated COVID Hospital with 1800 beds including 350 ICU beds after an Institutional Ethics Committee (IEC) approval. Confirmed COVID-19 RT–PCR-positive patients admitted to the DCH from March 10, 2021 to May 10, 2021 were asked history of vaccination and subjected to a predesigned standardized study proforma. Blood investigations were done at regular intervals. Regular standard of care was given to all patients. All cases post AZD1222 (Covishield) vaccine were categorized into two groups depending on the number of doses received and the data were statistically analyzed. Conclusion: As demonstrated by biochemical and radiological evaluation, two doses of the vaccine significantly reduced the severity of COVID-19 disease compared with a single dose, reducing the need for treatment interventions and also reducing the duration of hospitalization.

Keywords: COVID-19, COVID vaccine, post-vaccination


How to cite this article:
Walinjkar R, Chavhan SS, Adsul B, Dhikale PT, Shinde RH, Gokhale C, Ingale A, Pawar PN. Clinical profile of post-vaccination COVID-19-positive patients. D Y Patil J Health Sci 2021;9:107-12

How to cite this URL:
Walinjkar R, Chavhan SS, Adsul B, Dhikale PT, Shinde RH, Gokhale C, Ingale A, Pawar PN. Clinical profile of post-vaccination COVID-19-positive patients. D Y Patil J Health Sci [serial online] 2021 [cited 2022 May 27];9:107-12. Available from: http://www.dypatiljhs.com/text.asp?2021/9/3/107/345102




  Introduction Top


The COVID-19 vaccination in India was started on January 16, 2021 with two vaccines which included AZD1222-ChAdOx1-S (Covishield), manufactured in India by Serum Institute of India through license from Astrazeneca-Oxford, and BBV152 (Covaxin), indigenous vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).[1] The efficacy of AZD1222 (ChAdOx1-S) after administration of two doses of the vaccines irrespective of interval between the doses has been reported as 63.1%, with possibly higher efficacy on longer intervals. BBV152 has a 78% efficacy against SARS-CoV-2 infection according to interim phase-3 clinical study results.[2]

The Government of India initially targeted high-risk groups of healthcare workers, frontline workers, geriatric population, above 45 years with co-morbidities, and later extended vaccination to all adults as the second wave was severely affecting even the younger population.[1]

As per Ministry of Health and Family Welfare (MoHFW), Government of India, total vaccinations in the country are 24,27,26,693 as on June 10, 2021, 08:00 IST.[3] Vaccinations for COVID-19 are now available to all above 18 years of age in India. However, spread of COVID-19 infection continues unabated. Though the vaccines are shown efficacious in clinical trials, it is necessary to study their real-world effectiveness, and there is lack of adequate data regarding this. In this study, we aimed to assess clinical profile of patients of COVID-19 post-vaccination.


  Materials and Methods Top


Study setting

The study was done in a DCH with 1800 beds including 350 ICU beds.

Study design and population

This was a hospital-based cross-sectional study. Permission of Institutional Ethics Committee (IEC) was taken.

Patients admitted to the DCH from March 10, 2021 to May 10, 2021 were asked history of vaccination and subjected to a predesigned standardized study proforma. This included sociodemographic data, comorbidities, vaccination details, duration of stay, history of current COVID-19 symptoms, HRCT severity score, treatment received, outcome, etc. Blood investigations were done at regular intervals. It was possible to do IgG quantitative levels by electrochemiluminescence immunoassay using the Elecsys Anti-SARS-CoV-2 S kits from Cobas for 12 individuals who were post two doses of the vaccine. All the above details were obtained by trained individuals. All the cases had a nasal or throat swab reverse transcriptase–polymerase chain reaction (RT–PCR)-positive report on admission or were tested positive by RT–PCR post admission. A total of 113 cases were reported during the study duration out of which 2 cases were international travelers who had taken BBIBP-CorV (Sinopharm COVID-19 vaccine). There were 4 cases post administration of BBV152 and the rest 107 cases had taken AZD1222 vaccine. As the number of cases post BBV152 and BBIBP-CorV were very less, they were not taken for the purpose of statistical analysis in this study. All cases post AZD1222 vaccine were categorized into two groups depending on the number of doses received, namely, group A (n = 87) who had taken single dose of vaccine and group B (n = 20) who had taken both the doses of the vaccine.

Breakthrough infections were defined as per the standard definition as RT–PCR-positive report in a respiratory specimen collected from a person ≥14 days after receipt of two doses of the vaccine and were a part of group 2.[4] Regular standard of care was given to all patients as per the hospital protocol which was on par with the Updated Detailed Clinical Management Protocol for COVID-19 developed by MoHFW, Government of India.[5]

Statistical analysis

Data entry was done by using Google Forms and Microsoft Excel version 2010 and statistical analysis was done using IBM SPSS Statistics for Windows, version 16. Chi-square test, Fisher’s exact test, were T-test were used to compare between the two groups. The level of significance was fixed at 0.05.


  Results Top


The individuals who had completed both the doses of the vaccine had significantly lesser severity of COVID-19 disease in terms of HRCT score, inflammatory markers, requirement of steroid and remdesivir, and also shorter duration of hospital stay when compared with those who had taken single dose of the vaccine.

Out of the total 107 cases, 87 had received single dose of the vaccine, 20 cases had received both doses of which 6 were tested positive within 14 days of vaccination and 14 cases of these were breakthrough cases (as shown in [Figure 1] and [Table 1]).
Figure 1: Distribution of cases as per number of doses of AZD1222 received

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Table 1: Comparison of inflammatory markers in the two groups

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The baseline characteristics of the study population are summarized in [Table 2]. In individuals who had taken both doses of the vaccine, the duration (mean±SD) between the two doses was 32.3±5.81 days. The age in years (mean ± SD) in Group A and Group B was 57.87±17 and 47.65±15.97, respectively, and the difference was statistically significant (P = 0.016). IgG antibody levels for the 12 individuals mean ± SD were 4628.30 ± 6069.71 (U/mL).
Table 2: Demographic details and co-morbidities of the cases in the two groups

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Out of all the cases, only one individual was previously affected with COVID-19 and was found to have no CT changes on admission and was discharged after a hospital stay of 5 days during which he had no symptoms.


  Discussion Top


In the current study, 13.1% were breakthrough infections. Vaccines have effectiveness in decreasing risk of getting COVID-19 infections by only 70–90% and also shield from severe infections.[6] Therefore, there is a chance that few of the individuals may get COVID-19 infection even post-vaccination. Moreover, due to a variety of factors such as the dynamics of disease exposure, diminished antibody response in subgroups such as the elderly and immune-compromised, and the emergence of newer mutant strains with greater infectivity and virulence, the vaccine efficacy in the real world may differ from that reported in clinical trials. According to the ICMR, between 0.02% and 0.04% infections have occurred after partial or complete vaccination with either Covaxin or AZD1222, respectively [Table 3][Table 4][Table 5][Table 6].[2]
Table 3: Distribution of cases as per time elapsed post-vaccination till RT–PCR positive

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Table 4: Incidence and duration of symptoms of COVID-19 in vaccinated patients

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Table 5: Treatment and outcome in the two groups

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Table 6: Comparison of adverse effects post-immunization (AEFI) after each dose

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A study in Delhi, India showed a total of 37 (11.3%) breakthrough infections out of 325 total healthcare workers enrolled in the study.[2] Another similar study in a cohort of healthcare workers in a tertiary care hospital, out of 113 individuals who were vaccinated, 19 persons (16.9%) were found to be COVID-19-positive post-vaccination.[6]

In the current study, it was observed that majority of the post-vaccination cases had received AZD1222 vaccine. This can be attributed to the fact that of the total vaccinations in Mumbai, only approximately 6.9% have received BBV152, whereas other 93.1% have received AZD1222.[7]

It is known that an individual not having prior COVID infection (sero-negative for COVID-19 antibodies) develops antibody response only 14 days or later post-vaccination.[8] Thus the individuals affected during the first 14 days after first dose were either in incubation period when vaccinated or were infected before the antibodies to the vaccine could develop. This is probably the reason why majority of the cases were tested positive within the first 2 weeks of the first dose in this study. Also, we observed significant difference in the age between the two groups as vaccination was started earlier for frontline workers and then later for those above 60 years.[1]

Individuals who were tested for the antibody levels were post 2 weeks after the second dose. Despite having a positive IgG antibody titer with a mean±SD of 4628.30 ± 6069.71 (U/ml), these cases were found to be tested positive. Further evaluation would be required to evaluate whether these individuals were affected by a strain which was resistant to the antibodies produced by the vaccine or a higher antibody titer is required for protection from infection.

There was no statistically significant difference in the incidence or duration of symptoms of COVID-19 between the two groups. This is probably due to the fact that the “Updated Detailed Clinical Management Protocol for COVID-19” developed by MoHFW, Government of India suggests that the asymptomatic cases and those classified as mild do not need hospitalization and are advised home quarantine.[5] There may have been a larger number of individuals who were tested positive by RT–PCR post-vaccination, but they were either asymptomatic or having only mild symptoms and were home quarantined leading to over estimation of the severity of symptoms of the breakthrough infections as expected in a wider general population.

The inflammatory markers, including interleukin-6 (IL6), D-dimer, ferritin, LDH, and high-sensitivity C-reactive protein (hs-CRP) levels, were found to be indicative of severe COVID-19 in previous reports.[9],[10],[11] In this study, it was observed that the inflammatory markers, namely, IL6 on admission (P = 0.003), IL6 peak value (P = 0.002), hs-CRP on admission (P < 0.001), hs-CRP peak value (P < 0.001), Sr. ferritin on admission (P = 0.014), Sr. ferritin peak value (P = 0.001), Sr. LDH on admission (P = 0.050), and D-dimer peak value (P = 0.004), were lower in group B when compared with those in group A. Thus, it can be deducted that the incidence of cytokine storm and also the severity of the disease based on inflammatory markers were significantly less in the group with individuals post two doses of the vaccine.

In this study, out of the two groups, those who had received one dose of the vaccine were given significantly more treatment with steroids (P = 0.01), anticoagulation (P = 0.001), and remdesivir (P = 0.006) when compared with the group who had received two doses of the vaccine. Favipiravir was given more commonly in group B (10%) than in group A (6.1%); however, this difference was not statistically significant. This was probably due to the fact that remdesivir was preferred in severe disease over favipiravir by the physicians in this DCH.

Individuals who had received two doses had significantly lower CT severity score grade when compared with the other group (P = 0.003). This is relatable to the low inflammatory markers and hence lesser lung involvement and in turn better outcome.[12]

The number of individuals requiring oxygen supplementation in group 2 was also lesser; however, this difference was not statistically significant. Moreover, there was no ICU requirement or death in the group who had received both the doses of the vaccine.

Further studies are currently ongoing on this subject, and more data are becoming available as a larger population is being vaccinated.


  Conclusion Top


Two doses of the vaccine significantly reduced the severity of COVID-19 disease as observed on the basis of biochemical and radiological investigations when compared with that after a single dose. There was also a significant reduction in the requirement of treatment interventions and also reduction in the duration of hospital stay after two doses of the vaccine.


  Limitations Top


The study, being a hospital-based study, does not include individuals who are home quarantined.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
About the Vaccine, COVID-19 Vaccine FAQs [Internet] [cited June 10, 2021]. Available from: https://www.mohfw.gov.in/covid_vaccination/vaccination/faqs.html. [Last accessed on 2022 Jan 1].  Back to cited text no. 1
    
2.
Sharma P, Mishra S, Basu S, Tanwar N, Kumar R Breakthrough infection with SARS-CoV-2 and its predictors among healthcare workers in a medical college and hospital complex in Delhi, India. medRxiv2021;2021.06.07.21258447.  Back to cited text no. 2
    
3.
MoHFW | Home [Internet]. Ministry of Health and Family Welfare, Government of India [cited June 10, 2021]. Available from: https://www.mohfw.gov.in/. [Last accessed on 2022 Jan 1].  Back to cited text no. 3
    
4.
COVID-19 Vaccine Breakthrough Infections Reported to CDC—United States, January 1–April 30, 2021 | MMWR [Internet] [cited June 28, 2021]. Available from: https://www.cdc.gov/mmwr/volumes/70/wr/mm7021e3.htm. [Last accessed on 2022 Jan 1].  Back to cited text no. 4
    
5.
Updated Detailed Clinical Management Protocol for COVID19 Adults Dated 24-05-2021.pdf [Internet] [cited June 28, 2021]. Available from: https://www.mohfw.gov.in/pdf/UpdatedDetailedClinicalManagementProtocolforCOVID19 adultsdated24052021.pdf. [Last accessed on 2022 Jan 1].  Back to cited text no. 5
    
6.
Tyagi K, Ghosh A, Nair D, Dutta K, Singh Bhandari P, Ahmed Ansari I, et al. Breakthrough COVID19 infections after vaccinations in healthcare and other workers in a chronic care medical facility in New Delhi, India. Diabetes Metab Syndr 2021;15:1007-8.  Back to cited text no. 6
    
7.
CoWIN Dashboard [Internet] [cited June 28, 2021]. Available from: https://dashboard.cowin.gov.in/. [Last accessed on 2022 Jan 1].  Back to cited text no. 7
    
8.
Ujjainia R, Tyagi A, Sardana V, Naushin S, Bhatheja N, Kumar K, et al. Effect monitoring and insights from vaccination program of healthcare workforce from a tertiary level hospital in India against SARS-CoV-2. medRxiv 2021;2021.02.28.21252621.  Back to cited text no. 8
    
9.
Wang G, Wu C, Zhang Q, Wu F, Yu B, Lv J, et al. C-reactive protein level may predict the risk of COVID-19 aggravation. Open Forum Infect Dis2020;7. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197542/. [Last accessed on 2022 Jan 1].  Back to cited text no. 9
    
10.
Henry BM, de Oliveira MHS, Benoit S, Plebani M, Lippi G Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chem Lab Med 2020;58:1021-8.  Back to cited text no. 10
    
11.
Szarpak L, Ruetzler K, Safiejko K, Hampel M, Pruc M, Kanczuga-Koda L, et al. Lactate dehydrogenase level as a COVID-19 severity marker. Am J Emerg Med 2021;45:638-9.  Back to cited text no. 11
    
12.
Francone M, Iafrate F, Masci GM, Coco S, Cilia F, Manganaro L, et al. Chest CT score in COVID-19 patients: Correlation with disease severity and short-term prognosis. Eur Radiol 2020;30:6808-17.  Back to cited text no. 12
    


    Figures

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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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