|Year : 2021 | Volume
| Issue : 2 | Page : 219-223
COVID-19 vaccination status in Indian patients with cancer: An observational study
Ullas Batra1, Shrinidhi Nathany2, Nitin Bansal2, Mansi Sharma1
1 Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India
2 Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India
|Date of Submission||02-Jun-2021|
|Date of Decision||13-Jun-2021|
|Date of Acceptance||16-Jun-2021|
|Date of Web Publication||30-Jun-2021|
Sector 5 Rohini, Sir Chhotu Ram Marg, New Delhi - 110 085
Source of Support: None, Conflict of Interest: None
Background: Patients with cancer are at an increased risk of severe coronavirus disease-2019 (COVID-19). Hence, safe and efficacious vaccination against COVID-19 may play a crucial role in conferring protection to this group of patients.
Objectives: As there are no dedicated trials testing the safety and efficacy of COVID-19 vaccines in immunocompromised individuals or patients with cancer, we conducted this study to assess the vaccination status of Indian patients with cancer.
Materials and Methods: This single-center observational study was conducted in the Department of Medical Oncology at the Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India, between March and June 2021. Patients with cancer were interviewed telephonically to obtain information related to their vaccination status. The primary endpoint was the proportion of patients with cancer who received a COVID-19 vaccine. The Chi-squared test and McNemar's test were used to determine the associations between the different variables and the vaccination status.
Results: Of the 752 patients included in the study, 219 (29.1%) had received at least one dose of the COVID-19 vaccine. Of these, 34 (15.5%) patients subsequently developed COVID-19. They were treated in domiciliary care and did not require hospitalization. Of the 533 patients (70.9%) who were not vaccinated, 117 (21.9%) tested positive for COVID-19 and 14 (11.9%) succumbed to the disease.
Conclusion: Our study suggests that there is probably a lack of awareness or fear related to vaccination, which should be addressed to avoid COVID-19-related cancer mortality.
Keywords: Covaxin, COVID, Covishield, vaccination
|How to cite this article:|
Batra U, Nathany S, Bansal N, Sharma M. COVID-19 vaccination status in Indian patients with cancer: An observational study. Cancer Res Stat Treat 2021;4:219-23
|How to cite this URL:|
Batra U, Nathany S, Bansal N, Sharma M. COVID-19 vaccination status in Indian patients with cancer: An observational study. Cancer Res Stat Treat [serial online] 2021 [cited 2021 Sep 18];4:219-23. Available from: https://www.crstonline.com/text.asp?2021/4/2/219/320135
| Background|| |
In March 2020, the World Health Organization declared the coronavirus disease-2019 (COVID-19) a pandemic., Since then, efforts are being made to reduce the spread of the disease using non-pharmaceutical measures such as wearing a mask, imposing nationwide lockdowns and travel restrictions, and practicing social distancing. However, now the efforts are focused on developing effective vaccines against COVID-19 and restoring the pre-pandemic normalcy. Close to 28 million COVID-19 cases have been reported in India, with approximately 2.5 lakh deaths due to COVID-19, as per the data repository for the 2019 Novel Coronavirus Visual Dashboard operated by the Johns Hopkins University Center for Systems Science and Engineering.] The vaccination campaign in India was launched using two vaccines, Covaxin and Covishield. Covaxin is an inactivated viral vaccine, whereas Covishield is a replication-deficient chimpanzee adenovirus vector encoding the spike (S) glycoprotein of the severe acute respiratory syndrome coronavirus 2. The campaign was divided into three phases. In the first phase, immunocompromised individuals, those with comorbidities, those aged >60 years, and frontline COVID-19 health-care workers were included. In the second and third phases, the campaign was extended to the population at large including those aged >45 years and >18 years, respectively.
It is well known that patients with cancer are at an increased risk of severe COVID-19, as evidenced by a retrospective study on 73 million patients in the United States, in which the adjusted odds ratio for COVID-19 and cancer was reported to be 7. The severity of COVID-19 in patients with cancer may be attributed to their immunocompromised state due to cancer-directed therapies; moreover, in patients with hematolymphoid malignancies, the activation of the immune system may result in cytokine imbalance. Hence, safe and efficacious vaccination in this group of patients may be crucial for the prevention of severe COVID-19. However, the exclusion of the immunocompromised individuals and patients with cancer from the preliminary vaccine trials makes it challenging to assess the safety and efficacy of COVID-19 vaccines in this unique population. Hence, data from other groups of individuals were extrapolated to this group to estimate the efficacy and safety of the vaccines in patients with cancer, before the recommendations were laid down.
Therefore, this study was aimed at assessing the COVID-19 vaccination status of Indian patients with cancer.
| Methods|| |
General study details
This single-center, cross-sectional observational study was conducted in the Department of Medical Oncology of the Rajiv Gandhi Cancer Institute and Research Centre, a tertiary care center in Delhi, India, between March and June 2021. The study was reviewed by the Institutional Ethics Committee of the institute (Res/SCM/46/2021/86), and the requirement to obtain written informed consent from patients was waived. The study was conducted in accordance with the ethical guidelines outlined in the Declaration of Helsinki. The study was not a clinical trial, and hence was not registered in any public clinical trial registry. There was no funding for the study.
All patients diagnosed with a malignancy and visiting a specialty oncology outpatient facility over a period of 4 months were included in the study, regardless of their age, sex, type of cancer, stage of cancer, and type of cancer-directed treatment received (surgery, radiation, chemotherapy, targeted therapy, etc.). All patients included were diagnosed cases of solid organ malignancies on treatment. There were no patients of hematologic malignancies in this study as none attended the clinic during the recruitment period.
The primary endpoint of the study was the proportion of patients with cancer who had received a COVID-19 vaccine. The secondary endpoint was to assess the status of COVID-19 vaccination in the patients based on their age and sex and to evaluate the proportion of patients who had been affected by COVID-19.
Data related to the basic demographic features of the patients, including the age, sex, and cancer diagnosis were retrieved from the electronic medical record archives of the institute. The status of COVID-19 vaccination was sought from the patients either by enquiring with them in person or through a telephonic follow-up. In addition, the type of vaccine and dosing dates were recorded, along with the patients' COVID-19 infection status and well-being status.
No formal sample size calculation was calculated for this study. All statistical analyses were performed using the Statistical Package for the Social Sciences version 25 ((IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.), Geneva). Graphs and plots were generated using Microsoft Excel and GraphPad Prism v7. Descriptive statistics were used to assess the vaccination status. The patients were categorized according to their age, based on the class intervals used in the Indian Government's vaccine roll-out campaign; the class intervals were not statistically determined. The Chi-squared test and McNemar's test were used to determine the associations between the study variables and the vaccination status, wherever suitable. A P < 0.05 was considered statistically significant.
| Results|| |
A total of 752 patients with cancer were interviewed telephonically. The questions asked during the interview are listed in [Table 1]. The median age of the patients was 56 years (range: 15–87 years), and the male-to-female ratio was 1.02: (males: 380 [50.5%], females: 372 [49.5%]).
Of the total 752 patients, 219 (29.1%) had received at least one dose of a COVID-19 vaccine, and 57 (7.6%) patients had received both the doses of the vaccine. A total of 173 (78.9%) patients had received Covishield, and 46 (21.1%) had received Covaxin. The COVID-19 vaccination status of the patients with cancer according to their age and sex is depicted in [Figure 1] and [Figure 2]. The number of patients vaccinated against COVID-19 from January to June 2021 is depicted in [Figure 3].
|Figure 1: Coronavirus disease-2019 vaccination status of patients with cancer according to the age group|
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|Figure 2: Coronavirus disease-2019 vaccination status of patients with cancer according to sex|
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|Figure 3: Number of patients vaccinated against coronavirus disease-2019 from January to June 2021|
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The number of patients vaccinated in the age group of 18–44 years was 22 (10%), in the age group of 45–59 years was 91 (41.6%), and in the age group of ≥60 years was 106 (48.4%) (P < 0.0001). There was no statistically significant difference in the vaccination status of the male and female patients.
Of the 219 patients who received the vaccine, 34 (15.6%) subsequently contracted COVID-19 infection. Out of these 34 patients, only 4 (11.8%) had received both the doses of the vaccine at the time of data evaluation in the study. None of these 34 patients reported a severe illness and recovered in domiciliary care. The median time to contracting COVID-19 was 42 days after receiving both the doses and 38 days after receiving a single dose. However, the number of patients in our study who received both the doses of the vaccine was small, and hence, these results should be interpreted with caution. Among the rest of the 533 patients (70.9%) who did not receive the COVID-19 vaccine, 117 (21.9%) contracted COVID-19 infection (P < 0.002), and 14 (11.9%) of these patients died due to COVID-19-related complications. A summary of our findings is depicted in [Table 2].
|Table 2: A summary of findings in the vaccinated and nonvaccinated groups|
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| Discussion|| |
Our study describes the current vaccination status of the Indian patients with cancer. Less than a third of the patients visiting an oncology specialty outpatient department had received at least one dose of the COVID-19 vaccine. In addition, we found no statistically significant difference in the vaccination status of the male and female patients. We also found that older patients were more likely to have been vaccinated, which is concordant with the Government of India's vaccine age-wise roll-out strategy. Of note, however, immunocompromised persons irrespective of age were included in the first leg of the campaign.
To the best our knowledge, no reports related to the vaccination status of patients with cancer have been published so far. Moreover, none of the vaccine trials included patients with cancer.,,Thus, there are no evidence-based data supporting the safety and efficacy of COVID-19 vaccination in this population. As the evidence has been extrapolated to patients with cancer, it needs more elucidation. The trial for Covishield (ChAdOx1 nCov-19 vaccine) included 11,636 participants (excluding individuals affected by cancer) in the primary analysis and showed that the overall vaccine efficacy was 70.4%. Participants in the control arm of the trial (n = 4455) received the meningococcal Group A, C, W, and Y conjugate vaccine or saline; of these, 10 (0.2%) participants tested positive for COVID-19 and were hospitalized, with 2 (20% of the 10 cases which were hospitalized with COVID-19) showing severe forms of COVID-19. Participants in the test arm received the ChAdOx1 nCov-19 vaccine, and no cases of COVID-19 were reported in this arm. This is similar to what we observed in our study.
In our study, of those who did not receive the vaccine, 117 (21.9%) contracted COVID-19-positive disease, of which 17 (11.9%) succumbed to the infection/COVID-19-related complications. This percentage is higher than that reported in the above-mentioned trial, which may be attributed to real-world nature of this study versus a controlled trial; additionally, patients with cancer were excluded from the study, and it is well-known that COVID-19 related mortality is higher in patients with cancer. The median time to contracting COVID-19 was 42 days after receiving both the doses and 38 (15.6%) days after receiving a single dose in our study. Among those who received the vaccine, 34 contracted COVID-19-positive disease and all were managed in domiciliary care with no COVID-related mortalities, indicating that all had mild disease. Of these only 4 patients had received both the doses of the vaccine. In the pivotal Covishield trial, however, none of the patients contracted COVID-19 disease.
Our study had some limitations. The patients in our study were categorized according to their age, based on the class intervals used in the Indian Government's vaccine roll-out campaign. However, individuals with comorbidities irrespective of their age were included in the first phase of the vaccination campaign. Despite this, the number of patients who have received the COVID-19 vaccine in our study was glaringly low. In addition, our study is limited by its descriptive design and limited statistical analyses.
Nevertheless, our study is impactful for the oncology fraternity of the Indian subcontinent and can urge them to persuade and convince their patients with cancer to get vaccinated against COVID-19. Future evaluation of response to vaccination in terms of the cancer-directed therapies administered, type of malignancy, and antibody responses may enhance our understanding about the safety and efficacy of the COVID-19 vaccination in patients with cancer. It will also help us lay down national guidelines for vaccine administration in this vulnerable group of patients.
| Conclusion|| |
In conclusion, our study highlights the need to create more awareness about COVID-19 vaccination to improve its uptake in patients with cancer and avoid COVID-19-related cancer mortality.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]