|Year : 2021 | Volume
| Issue : 3 | Page : 162-164
How safe is Covishield (ChAdOx1nCoV-19) Vaccine? Experience from a Tertiary Care Hospital in South India
Leeberk Raja Inbaraj, Carolin Elizabeth George, Nirupama Navamani Franklyn
Division of Community Health and Family Medicine, Bangalore Baptist Hospital, Bengaluru, Karnataka, India
|Date of Submission||03-May-2021|
|Date of Decision||11-May-2021|
|Date of Acceptance||14-May-2021|
|Date of Web Publication||05-Jul-2021|
Dr. Carolin Elizabeth George
Department of Family Medicine and Community Health, Bangalore Baptist Hospital, Bengaluru - 560 024, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Coronavirus disease vaccine has been recently rolled out for health care workers in India. We aimed to determine the incidence of adverse events following immunization (AEFI) among healthcare workers (HCWs) after their first dose of the ChAdOx1nCoV-19 vaccine. Methodology: We recruited 218 HCWs for this cross-sectional study. We circulated a google form on the hospital and asked them to self-report their vaccination experience. Results: Two-thirds (69.7%, 95% confidence interval [CI]: 63.1–75.7) had minor AEFI, and none had severe AEFI. Body ache (46.8%, 95% CI: 40–53.6) was the most common symptom followed by headache (30.3%, 95% CI: 24.2–36.8). Most of them (39.4%, 95% CI: 32.9–46.2) experienced symptoms within 4–24 h after taking the vaccine. Majority (78.9%) were anxious before the vaccination. The younger age group and female gender were significantly associated with AEFI. Conclusion: HCWs experienced minor, self-limiting AEFI with the first dose of ChAdOx1nCoV-19. The hospital reported no serious AEFI following the vaccination.
Keywords: ChAdOx1nCoV-19, COVID-19 vaccine, covishield, healthcare workers, safety profile
|How to cite this article:|
Inbaraj LR, George CE, Franklyn NN. How safe is Covishield (ChAdOx1nCoV-19) Vaccine? Experience from a Tertiary Care Hospital in South India. Curr Med Issues 2021;19:162-4
|How to cite this URL:|
Inbaraj LR, George CE, Franklyn NN. How safe is Covishield (ChAdOx1nCoV-19) Vaccine? Experience from a Tertiary Care Hospital in South India. Curr Med Issues [serial online] 2021 [cited 2022 Aug 10];19:162-4. Available from: https://www.cmijournal.org/text.asp?2021/19/3/162/320659
| Introduction|| |
Ever since the coronavirus disease (COVID-19) pandemic, India has recorded more than 10.5 million cases and 150000 deaths. India began its vaccine roll out against COVID-19 on16 January 2021 to healthcare workers (HCWs), almost a year after the index case was detected in the sub-continent. The country has approved two vaccines so far. Covaxin, a whole-Virion Inactivated VeroCell vaccine developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Covishield (ChAdOx1nCoV-19), recombinant vaccine manufactured by serum institute of India in partnership with Oxford-AstraZeneca. The Government of India (GOI) has procured 11 and 5.5 million doses of Covisheild and ChAdOx1nCoV-19, respectively for the initial rollout.
Although the country has experienced the pandemic's fury, many rumors were associated with the vaccine, even among the health care workers (HCWs). Hence vaccine was welcomed with the paradox of urgency and hesitancy. Though vaccine trials and data are available, people, including HCWs, need more real-life data from their contexts to get over the vaccine hesitancy. We aimed to determine the incidence of adverse events following immunization (AEFI) among HCWs after their first dose of the ChAdOx1nCoV-19 vaccine.
| Methodology|| |
We conducted a cross-sectional study among HCWs of Bangalore Baptist Hospital (BBH), 350-bed tertiary care teaching hospital with close to 1500 staff located in South India. The hospital had treated more than 2000 COVID-19 inpatients in the past ten months. Out of 1376 staff members registered for the vaccine, only 758 (55.08%) took the vaccine.
Assuming 50% of the vaccinated HCWs develop minor AEFI, a minimum sample size of 97 was calculated with a relative precision of 20%. We circulated a google form with informed consent on the hospital WhatsApp platform and asked them to self-report their vaccination experience after their consent. The questionnaire contained demographic information, their anxiety level before taking the vaccine, and questions on AEFI. Data were analyzed in the Statistical Package for Social Sciences for Windows (SPSS Inc. Released 20017, version 23.0. Armonk, New York, USA). Sociodemographic factors, history of COVID-19 infection, comorbid conditions, level of anxiety were dichotomized and tested for significance using the Chi-square test. This study was approved by the Institutional Review Board of BBH on January 21, 2021.
| Results|| |
Out of 758 vaccinated HCWs, 218 (28.6%), have responded to the survey [Table 1]. The mean age of the participants was 36 years (standard deviation-9.5). Diabetes (19 (8.7% (19/218) 95% confidence interval [CI]: 5.3–13.2), and hypertension (8.2% (18/218), 95% CI: 3.5–10.5) were the most common comorbidities.
Almost two-thirds (69.7% (152/218), 95% CI: 63.1–75.7) had minor AEFI, and none had severe AEFI. When HCWs were asked to rate the severity of AEFI, more than half of them (51.8% (113/218), 95% CI: 44.9–58.6) perceived it as mild, while (3.2% (7/218), 95% CI: 1.3–6.5) rated it as severe. Body ache (46.8% (102/218), 95% CI: 40–53.6) was the most common symptom followed by headache (30.3% (66/218), 95% CI: 24.2–36.8) and fever (22% (48/218), 95% CI: 16.7–28.1) [Table 2]. Many (39.9%, 95% CI: 33.3–46.7) took medications for their symptoms, and one required admission for observation. Most of them (39.4% (87/218) 95% CI: 32.9–46.2) experienced symptoms within 4–24 h after taking the vaccine while 49 (22.3% 95% CI: 17.1–28.6) experienced it after a day.
|Table 2: Self-reported adverse event following immunization by the study population|
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The majority of the respondents (78.9% (172/218), 95% CI: 72.8–84.1) were anxious before the vaccination. Anxiety before the vaccination was reported as mild by (50.9 (111/218) 95% CI: 44–57.7) and as severe by 8.7% (19/218) (95% CI: 5.3–13.2). More than two-thirds (61.5% (134/218), 95% CI: 54.6–67.9) felt happy to have received the vaccine, and 88.1% (192/218) (95% CI: 83–92) said they would be taking the next dose of vaccine.
Level of anxiety, type of occupation, comorbid conditions, history of COVID infection in the past was not significantly associated with AEFI. The younger age group (23.9% vs. 6.6%) and female gender (20.9% vs. 6.5%) were significantly associated with AEFI compared to their counterparts (P < 0.05).
| Discussion|| |
We found that ChAdOx1nCoV-19 has a good safety profile. Our findings concur with phase 2–3 safety trial data of ChAdOx1nCoV-19 where 88% of the participants between the age of 18 and 55 years experienced at least one local symptom and recent evidence also suggests that it is safe, tolerated, and immunogenic, while reactogenicity was reduced with paracetamol., After rolling out 45 lakh doses, the GOI reported an overall AEFI of 0.18%, of which 0.0007% required hospitalizations. Similar experience has also been observed in Nepal that none developed severe side effects after the first dose. Most of these were “injection-related side effects” and immunization anxiety-related reaction similar to our study. Nineteen vaccinated HCW's have died in the country so far, but none have been attributed to the vaccine.
The high prevalence of anxiety (78.9%) is not surprising owing to various reasons. Fast-tracked vaccine development, limited knowledge about long-term effects, controversies on Covaxin's approval without phase-3 trial, and social media could have mounted the anxiety. Many still believe that vaccines are still a “hit or miss strategy” than an adequately evaluated prevention measure. Even in a hospital, where the risk of infection is high, the percentage of vaccine takers was only 55.08%. Anxiety can be one of the main reasons for vaccination hesitancy in our center and in the country. However, we cannot comment on this, as our sample had only HCWs who took the vaccine.
In our study, the younger age group and female gender were associated with minor AEFIs. High reactogenicity of ChAdOx1nCoV-19 in the younger age group was documented. However, we did not find any supporting evidence for high reactogenicity among women, and this may be due to the higher proportion of women in our sample. Although anxiety is thought to be associated with AEFI, we could not find this association in our study. There is also a possibility that most people with severe anxiety would have refrained from vaccination.
To the best of our knowledge, this is the first study from the country exploring the incidence of AEFI among HCW. The study has an adequate sample size and a reasonable response rate. The study used a WhatsApp platform; hence, we would have missed those who did not have smartphones.
| Conclusion|| |
HCWs experienced minor, self-limiting AEFI with the first dose of ChAdOx1nCoV-19. The hospital reported no serious AEFI following the vaccination. ChAdOx1nCoV-19 has a good safety profile, and we believe our findings will encourage people to come forward and receive this public health tool to break the chain of transmission.
We extend our thanks to staff of BBH in taking part in this study. We would like to extend our gratitude to Ms. Sherin Manichen for her assistance in analysis.
Research quality and ethics statement
All authors of this manuscript declare that this scientific study is in compliance with standard reporting guidelines set forth by the EQUATOR Network. The authors ratify that this study required Institutional Review Board approval of Bangalore Baptist Hospital, and hence prior approval was obtained 21.01.2021. We also declare that we did not plagiarize the contents of this manuscript and have performed a Plagiarism Check.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]