|Year : 2022 | Volume
| Issue : 2 | Page : 109-113
Adverse drug reactions and potential risk factors to Covishield vaccine: A cross-sectional study among dentists of different tertiary care centers
Kopal Sharma1, Kanu Neemawat2, Amit Sharma3
1 Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan, India
2 Department of Pathology, SMS Medical College, Jaipur, Rajasthan, India
3 Department of Oral and Maxillofacial Surgery, Rajasthan Dental College, Jaipur, Rajasthan, India
|Date of Submission||04-Sep-2021|
|Date of Decision||24-Mar-2022|
|Date of Acceptance||29-Mar-2022|
|Date of Web Publication||01-Jul-2022|
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan
Source of Support: None, Conflict of Interest: None
Background: This study aims to study the predictors and the pattern of adverse drug reactions to Covishield vaccine which is being used in the mass vaccination program of the Government of India.
Methods: This cross-sectional questionnaire-based study was conducted among the dentists working as faculty in four different tertiary care centers in Jaipur city. A prevalidated questionnaire was circulated through E-mail/social media groups to all the participants.
Results: A total of 574 participants fulfilled the questionnaire platform; however, six had been excluded from the study due to incompletely filled questionnaires. The remaining 568 were enrolled for the final analysis. About 296 (52.11%) were male and 272 (47.89%) were female. About 52.8% were in the age group of 31–49 years. About 87.32% of the enrolled participants had received both doses of Covishield. Most common postvaccination symptoms were fever (n = 145), local pain at injection site (n = 123), tenderness at injection site (n = 117), and fatigue (n = 91). Female gender, presence of comorbid diseases, and past coronavirus disease-19 infection were statistically significant risk factors for having adverse reactions post vaccination, P = 0.02, 0.043, and 0.0002, respectively.
Conclusions: The data suggest that Covishield is well tolerated in the Indian population. Fever, local pain, tenderness at injection site, and fatigue are few commonly reported side effects. All the side effects were mild to moderate in terms of severity.
Keywords: Adverse drug reactions, Covishield, risk factors
|How to cite this article:|
Sharma K, Neemawat K, Sharma A. Adverse drug reactions and potential risk factors to Covishield vaccine: A cross-sectional study among dentists of different tertiary care centers. J Oral Res Rev 2022;14:109-13
|How to cite this URL:|
Sharma K, Neemawat K, Sharma A. Adverse drug reactions and potential risk factors to Covishield vaccine: A cross-sectional study among dentists of different tertiary care centers. J Oral Res Rev [serial online] 2022 [cited 2022 Aug 15];14:109-13. Available from: https://www.jorr.org/text.asp?2022/14/2/109/349711
| Introduction|| |
The coronavirus disease-19 (COVID-19) pandemic has resulted in substantial morbidities and mortalities owing to its high transmission rate. Starting with a few drugs in the treatment list for this virus, scientists have left no stone unturned to drive various treatment regimens and possible vaccines for this virus. In early January 2021, the Drugs Controller General of India gave green light to two vaccines for emergency use in India. First, the “COVAXIN” was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research. Second, the “Covishield” Oxford-AstraZeneca vaccine was manufactured locally by the Serum Institute of India. Covishield is a nonreplicating chimpanzee adenovirus vaccine vector (ChAdO × 1) requiring a storage temperature of 2°C–8°C. Common adverse drug reactions (ADRs) found in the Phase II trial of Covishield were pain, swelling, redness, and itching at the injection site; stiffness in the upper arm; weakness in the injection arm; pain in the body and head; fever; malaise; weakness; rashes; nausea; and vomiting.
The massive vaccination strategy initiated by the Government of India is adopted for survival and better quality of life in our country with the considerable number of reported cases. There are many myths regarding the side effects of COVID-19 vaccines which could be a frequent reason for vaccination aversion. These concern has raised the need to study the potential risk factors and various adverse effects of this new vaccine Covishield which is being administered to frontline health-care professionals of our institution as a part of the vaccination program of Government of India.
| Methods|| |
Study population and study period
This study was conducted among the faculty dentists working in four different tertiary care centers of Jaipur city (in Rajasthan) in May 2021 during the COVID pandemic.
This was a retrospective, observational study.
(1) All the faculty dentists working in four different tertiary care centers of Jaipur city and who had received Covishield. (2) Those who gave their consent for participation in the study.
(1) Other health-care workers (dental hygienists, nursing staff, and technicians), resident doctors, and intern students. (2) Those receiving vaccines other than Covishield or no vaccine.
A standardized questionnaire platform utilizing Google Forms was utilized to collect information about the participants. The face value for the questionnaire was established by two subject experts, then it was pilot tested on 80 participants to check its validity and reliability. The questionnaire included three major parts, in sequence: demographic data including age, gender, and department; clinical profile including any comorbid conditions, drug history, and COVID-19 infection status before and after vaccination; and vaccine data (number of doses received, side effects in term of duration and severity, and time of onset). The severity of the symptoms was determined using Hartwig scale for classification of the severity of adverse effects.
Participants were asked to fill out the form individually without any support and submit it in a week. The recorded responses were then analyzed initially for their completeness and quality.
Records of all the individual participants were coded and kept confidential. IBM Statistical Package for the Social Sciences for Windows version 17.0 software (IBM Corp., Armonk, NY, USA) was used for statistical analysis. Descriptive statistics such as frequency and percentage were used for demographic data. Fisher's exact and Chi-square tests were used to find the associated risk factors for developing adverse effects following vaccination. For all the analyses, odds ratio was 1 and P < 0.05 was considered statistically significant.
| Results|| |
A total of 574 participants fulfilled the questionnaire platform; however, six had been excluded from the study due to incompletely filled questionnaires. The remaining 568 were enrolled for the final analysis. About 296 (52.11%) were male and 272 (47.89%) were female. The age of most of them (52.81%) was in a range of 31–49 years. About 87.32% of the enrolled participants had received both the doses of AstraZeneca-Oxford vaccine (Covishield), while 12.67% had received only a single dose. About 52.82% of them had no history of COVID-19 virus infection till date, while 29.75% of the participants were infected with COVID-19 virus before the first dose and 13.03% after the first dose of vaccination.
Regarding medical anamnesis, 198 (34.58%) participants had at least one comorbid disease. Among them, 93 (46.9%) had hypertension, 42 (21.2%) had diabetes, 4 (2%) had thyrotoxicosis, 11 (5.5%) had asthma, and the remaining ill participants had different noncommunicable diseases such as hyperlipidemia, arthritis, and cancer. A total of 448 (78.87%) of 568 one had obvious adverse effects, ranging from mild to moderate in terms of severity, while 120 (21.13%) were asymptomatic; in addition, demographic characteristics are shown in [Table 1].
Prevalence of general adverse effects
The most common postvaccination symptoms were fever (n = 145), local pain at injection site (n = 123), tenderness at injection site (n = 117), and fatigue (n = 91) and the less likely appeared symptoms were rashes (n = 2), hypoglycemia (n = 1), and Bell's palsy (15 days after receiving the second dose) (n = 1); more symptoms are shown in [Figure 1]. The frequencies of each symptom are demonstrated in [Figure 1].
Associated risk factors of having postvaccination adverse effects
Participants <50 years of age were more prone to have adverse effects after vaccination; P < 0.0001. In females, there was a 1.5 times higher likelihood of having adverse effects as compared with males, as depicted in [Table 2]. The presence of comorbid diseases and past COVID-19 infection were statistically signiﬁcant risk factors for having adverse reactions post vaccination (P = 0.043 and 0.0002, respectively) [Table 2].
|Table 2: Univariate analysis of associated risk factors after Covishield vaccine|
Click here to view
| Discussion|| |
Recently, the Covishield vaccine has been introduced for emergency use authorization in India to control the pandemic; however, similar to other vaccines, it is not without adverse effects. In our study, of 568 participants, 402 (70.7%) were symptomatic and 166 (29.2%) were asymptomatic. Few most common symptoms noted in our study were fever (36.01%), local pain at injection site (30.6%), tenderness at injection site (29.1%), and fatigue (22.6%). Similar results were also mirrored in the previous studies from the Czech Republic and Iran., Another study in Wuhan also reported fever, fatigue, headache, and muscle pain by 46%, 44%, 39%, and 17%, respectively, as few frequent adverse effects in vaccinated individuals.
Only two participants (0.3%) suffered from postvaccination allergic reactions. This rate was <1.7% reported in other studies. This hypersensitivity is believed to be due to polysorbate 80 excipient added in the Covishield vaccine to improve its physical properties such as solubility, absorption, stability, or even to stimulate stronger immune responses. Several associated risk factors for developing adverse effects following COVID-19 vaccines were recognized in our study, such as ages <50 years. This ﬁnding is in concordance with the randomized controlled trials on the safety and efﬁcacy of the Covishield vaccine undertaken in Brazil, South Africa, and the UK which also documented lesser side effects in older adults postvaccination.
In our study, female gender was a significant risk factor for postvaccination adverse effects. This report was parallel to other previous studies., This finding can be explained as younger individuals and females have stronger immune responses as compared to elderly and male counterparts, respectively, they are expected to develop more adverse effects of greater intensity.
Another signiﬁcant risk factor for adverse reactions in our study was found to be previous SARS-CoV-2 infection among the vaccinated people (P = 0.0002). In correspondence, a UK-based study by Menni et al. reported similar findings. At present, there is no clear justification for this correlation. Participants with comorbidities such as hypertension, diabetes, hyperlipidemia, and others were also another recognized risk factor for postvaccine adverse effects (P = 0.043). The exact reason for this is yet to be determined by further prospective studies with a larger sample size.
Regarding the severity of symptoms, most symptoms were mild (73.63%) and moderate (26.37%), and no severe side effects were noted. This ﬁnding is similar to a study conducted in Wuhan which stated most symptoms as mild to moderate in severity.
About 80.4% of the participants did not report their adverse effects, while 21% were not knowing where and how to report their ADRs. This finding highlights the need for training of our health-care workers on reporting of adverse effects following immunization. This will further strengthen active surveillance simultaneously with the mass vaccination program of the Government of India. One of the limitations of this study is that the difference in the adverse events following different doses was not studied in detail, as the present study intended to focus on the predictors that influence the adverse effects irrespective of the dosing of the vaccination. However, this study effectively highlights the possible predictors of the adverse events following Covishield vaccination.
| Conclusions|| |
Keeping with recorded literature, fever, local pain and tenderness at the injection site, and fatigue were the most recorded side effects. Covishield-related adverse reactions occurred in 71% of the vaccine recipients; however, all the symptoms were mild to moderate with regard to severity and were tolerated well. Hence, the data suggest that the Covishield vaccine is safe. Further studies are warranted to study its long-term adverse effects.
The present study was conducted after approval from the institutional ethics committee (Reference number: 685 MC/EC/2021). Participants submitted their informed consent before participation.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]