|Year : 2021 | Volume
| Issue : 2 | Page : 60-64
Adverse event following immunization and relation with blood group following COVID19 Vaccination among Indian community: A cross-sectional study
Niraj Pandit, Nilesh Patel
Department of Community Medicine, SBKS and MIRC, Sumandeep Vidypeeth, Vadodara, Gujarat, India
|Date of Submission||18-Oct-2021|
|Date of Decision||16-Dec-2021|
|Date of Acceptance||22-Dec-2021|
|Date of Web Publication||15-Mar-2022|
Dr. Niraj Pandit
Department of Community Medicine, SBKS and MIRC, Sumandeep Vidyapeeth Deemed to be University, Piparia, Vadodara, Gujarat
Source of Support: None, Conflict of Interest: None
Introduction: In middle of the 3rd wave, COVID19 is now gradually making agent host environment balance at the world level. COVID19 vaccine is also available for the prevention of diseases. The two vaccines which are available in India till July 2021, they are COVISHIELD and Covaxin. There are various news heard about the relation of the ABO blood group and COVID19 disease. However, no study has tried to the relation of various blood groups and adverse events following immunization (AEFI). Methods: This was a community-based cross-sectional study. It was conducted online mode with the use of Google Forms. Study participants were Indian citizens and who took either Covishield or Covaxin as COVID19 vaccination. The pretested form was used, which consisted of various information regarding blood group of individual, vaccine, type of vaccine, doses of vaccine, side effects postvaccination, what is/are side effects and other information like do you have disease COVID19. Results: A total of 893 participated in the study, but out of them, 731 participants took vaccine either one or two doses. Most of the participants, 597 (87%), were from urban areas. The postCOVID19 vaccine AEFI prevalence was 69.7%. The association between ABO and Rh blood group and AEFI was not statistically significant. However, Covaxin has lesser side effects compared to COVISHIELD. Even a small group of COVID19 disease also had no association with ABO or Rh blood group. Conclusion: The side effects following the COVID19 vaccine are quite common. Majority were mild AEFI. There is no statistical association with blood group and postCOVID19 AEFI.
Keywords: ABO blood group, adverse events following immunization, covaxin, covishield
|How to cite this article:|
Pandit N, Patel N. Adverse event following immunization and relation with blood group following COVID19 Vaccination among Indian community: A cross-sectional study. J Integr Health Sci 2021;9:60-4
|How to cite this URL:|
Pandit N, Patel N. Adverse event following immunization and relation with blood group following COVID19 Vaccination among Indian community: A cross-sectional study. J Integr Health Sci [serial online] 2021 [cited 2022 May 24];9:60-4. Available from: https://www.jihs.in/text.asp?2021/9/2/60/339656
| Introduction|| |
In middle of the 3rd wave, COVID19 is now gradually making agent host environment balance at the world level. Now, the vaccine is also available for the prevention of diseases. Still, the fight between tiny microbes and the human species is going on. The year 2021, is the year which gave the good news to fight against COVID19 with the vaccine. There are 13 vaccines approved by various countries till date. Of which, two vaccines are approved and given to the Indian population. The vaccine drive was started in India on January 16, 2021, and it is the biggest vaccination drive of the world.
The two vaccines which are given in India, are COVISHIELD (ChAdOx1 CoV-19 VACCINE), which is AstraZeneca's vaccine manufactured by Serum Institute of India, and Covaxin, which is manufactured by Bharat Biotech Limited. COVISHIELD vaccine product information has reported more than 50% one or two side effects among trial participants. On the other side, there are only Phase 1 and Phase 2 trial data are available for Covaxin. As per that report, there are no serious adverse reaction and more information are awaited.
There are various news heard about the relation of the ABO blood group and Covid19 disease. The large cohort study conducted in Canada reported that blood group O and Rh-negative group of people are slightly protected from disease and severe COVID19 disease. Similarly, one more report from Nebraska Medicine said that people with blood group A have a higher risk of getting COVID19 than other blood group types. However, there was no study reported on the vaccine following side effects, adverse events following immunization (AEFI), and blood group in context to COVID19.
Looking at this background information, we thought to study the relation between blood group and Covid19 AEFI. The objectives of the study were to study the relation between blood group and adverse event following immunization of COVID19 vaccine, to study the prevalence of AEFI postCOVID19 vaccination, and to understand the relation between blood group and COVID19 infection Indian scenario.
| Methods|| |
This was a community-based cross-sectional online study. It was conducted online mode with the use of Google Forms.
Study participants were Indian citizens and who took either Covishield or Covaxin as COVID19 vaccination.
The study sample is based on the assumption that 50% will get AEFI and 50% will not get AEFI, as there are no data till date. With this 50% proportion and 5% error, the sample size will be 385. The sample section method was nonrandom and through the various social media and sharing on e-mail. There was open invitation to all to participate in the study via various modes like social media, e-mail, personal contact, etc., Total 893 participated in the study, but of them 731 took vaccine either one or two doses. In this study group, there was one question about do you have COVID19 disease. One hundred and forty-three participants had a history of COVID19 disease.
Study participation inclusion criteria
All Indian participants were eligible. Participants who took either COVISHIELD or Covaxin are eligible to join in the study. Participants who knew to use of Google Forms are included.
Participants who do not want to give consent will be excluded from the study.
After the institutional Ethics Committee's permission, the study was started with online pilot pretested form. The data collection form was developed on the Google Forms. The pretested form was consist of various information regarding blood group of individual, vaccine, type of vaccine, doses of vaccine, AEFI postvaccination, what is/are side effects and other information like do you have disease COVID19, when, required to admit and other sociodemographic information were collected. The first part of the form was the consent form, once agree the other parts could be filled. This form link was shared through social media and e-mails. The circulation was continued till the required data were collected. The validation of the study form was done through only one response could be collected from one device. The mobile number and mail ids were also collected and 10% of participants were contacted for validation of data.
The participants were given the consent on the first page, if they agree on consent, then only the next data collection form was filled. Participant's information was kept confidential. The data collection was done between April 2021 and June 2021. Thus, collected information was compiled and analyzed in EpiInfo software. The data were presented and analyzed with Chi-square test.
| Results|| |
Total 893 participated in the study, but out of them, 731 participants took vaccine either one or two doses. In this study group, there was one question about did you had COVID19 disease previously. About 143 participants had a history of COVID19 disease, this information was used to assess the relationship between blood group and COVID19 disease.
[Table 1] shows the sociodemographic profile of the study participants who took the vaccine. Out of 731 participants who had taken 1 or 2 dose vaccine, 354 (51%) were male and 332 (49%) were female. Most of the participants, 597 (87%), were from urban areas.
The postCOVID19 vaccine AEFI prevalence was 69.7%. All AEFI reported were mild to moderate. No serious AEFI was reported by the study participants.
In AB group participants, out of total 426 participants who received one or both doses of COVISHIELD, 296 (69.5%) participants had the experience of one or more AEFI due to vaccination, while out of total 29 participants who received one or both doses of Covaxin, 17 (58.6%) had the experience of one or more side effects due to vaccination. This difference was found statistically not significant as P > 0.05 [Table 2].
|Table 2: Relation between COVID-19 vaccines related side effects and various blood groups (n=731)|
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In O group participants, out of a total of 260 participants who received one or both doses of COVISHIELD, 190 (73.08%) participants had the experience of one or more AEFI due to vaccination, while out of a total of 16 participants who received one or both doses of Covaxin, 7 (43.75%) had the experience of one or more side effects due to vaccination. This difference was found statistically not significant as P > 0.05 [Table 2].
Similarly, Rh +ve and Rh −ve group participants had also experienced AEFI due to both vaccines. These differences were also found statistically not significant as P > 0.05 [Table 2].
Out of a total of 686 participants who have received COVISHIELD, 486 (70.85%) participants have experienced one of more AEFI, while out of a total of 45 participants who have received Covaxin, 24 (53.33%) have experienced one or more AEFI. This difference was found statistically significant as P < 0.05 [Table 3]. This concludes COVAXIN has less AEFI compared to Covishield.
The Chi-square statistic is 6.14. P value is 0.013216. Significant at P < 0.05.
AEFI like body ache, fever, fatigue, and headache were most commonly observed among those who were taken one or both doses of COVID19 vaccine. Only 25 (3.4%) of participants were required to consult the doctor for the side effects means moderate to serious side effects [Table 4].
|Table 4: Distribution of type of side effects (n=731, multiple answers are acceptable)|
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In the current study, few participants were found to have a history of COVID19 infection. Their data were analyzed to understand the relation between COVID19 disease and ABO blood grouping. AB group participants, out of a total of 566 participants, 97 (16.55%) participants had been infected by COVID19, while out of a total of 327 participants of the O group, 47 (14.06) participants had infected by COVID19. This association was statistically not significant as P > 0.05 [Table 5].
|Table 5: Relation between disease coronavirus disease-2019 and ABO blood group|
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In Rh +ve group participants, out of a total of 834 participants, 132 (15.82%) participants had been infected by COVID 19 while out of a total of 59 participants of Rh −ve group, 11 (18.65%) participants had infected by COVID 19. No statistically significant difference was observed as P > 0.05 [Table 5].
| Discussion|| |
The current study was to find out various relations with blood group and AEFI following the COVID19 vaccine. There was no association found in the current study with the ABO blood group or Rh blood group. Thus, the study concludes that the AEFI is present irrespective to the blood group. There was no such study conducted or it was not found on literature search.
The current study reported the prevalence of AEFI among the Indian population was almost 70% overall, with Covishield prevalence of AEFI was 70.85% and with Covaxin, it was 53.33%. Thus, Covaxin has less AEFI compared to Covishield. This proportion of AEFIs is quite high than reported by the manufactures, for Covaxin common side effects reported 12% and for Covishield, common side effects reported 10%. These very high reported AEFI among study participants may be due to very high IEC on vaccine side effects during the initial launch of vaccine drive. Furthermore, similarly, very high AEFI were reported by other studies. A study conducted at Busan, Korea by Jeon et al. reported almost 98% of the study participants had one or more AEFI with COVISHIELD (ChAdOx 1 nCov-19) vaccine. One more study from South Korea Bae et al. reported prevalence of AEFI 93% among COVISHIELD (ChAdOx 1) group and 80% among m-RNA based BNT162b2 vaccine. This difference was statistically significant P < 0.001. Similarly, in the current study also it was observed that COVISHIELD receivers had reported quite high AEFI compared to Covaxin participants. The study was conducted from South India Hospital by Kamal et al. reported 57% of participants developed nonserious AEFI postCOVISHIELD vaccine.
Thus, it is clear that vaccine AEFI is quite common with COVID19 vaccine and quite high in prevalence. However, these were mind to moderate AEFI. In a Korean study by Jeon et al. reported only 13 cases who required to consult doctors for AEFI. In the current study, these numbers were 25 (3.4%).
The study conducted among health care workers of the Czech Republic who received Pfizer BioNTech vaccine received by Riad et al. reported injection site pain as the most common side effect (89.8%), followed by fatigue (62.2%), headache (45.6%) and chills (43%). Osama Abu-Hammad et al. from Jordanian health-care worker study reported that the most common side effects were injection site pain (74%) followed by fatigue (52%), myalgia (44%), headache (42%), and fever (35%). The study from Korea by Jeon et al. reported fatigue (92.9%), malaise (83.8%) were most common AEFI whereas only 27.6% reported fever with Covishield. Study from South Korea Bae et al. reported pain at the injection site as most common (81.2%) AEFI with COVISHIELD and next were muscle pain (79.9%), fatigue (76.5%), and headache (69.5%). Whereas in the current study most common side effect was body ache (44.6%) followed by fever (43.8%), fatigue (36.8%), whereas injection site pain was not much observed (2.4%) [Table 4].
The study which was conducted by Hoiland et al. shows that COVID-19 patients with blood group A or AB are at increased risk for requiring mechanical ventilation versus those with blood group O or B and appear to exhibit a greater disease severity than patients with blood group O or B. Similar findings of Preliminary reports suggest a link between ABO blood groups and susceptibility to severe acute respiratory syndrome coronavirus 2 infection,, Majority of the published literature was trying to find out the association between COVID 19 severity and ABO blood grouping. Here, in the present study, it was observed that there is no statistically significant difference found even in COVID19 disease occurrence and blood group. Thus, it is clear that the disease is uniformly seen in all blood groups.
The current study has quite many limitations like the study was conducted online and participants has to disclose conditions voluntarily, so they might be subjective; second participants were more scattered all over the country and may not have complete representation; the third study did not collect information about comorbidity; forth the serious AEFI were not disclosed any participants and the fifth possibility of bias due to unobserved variables cannot be excluded.
| Conclusion|| |
The study concluded that the AEFI following COVID19 vaccine was quite common. However, majority are mild AEFI. The AEFI of COVID19 vaccine had no relation with ABO or RH blood group system. The side effects are equally distributed in all type of blood group. Similarly, in small number, it was observed that disease COVID19 has also no protection to particular blood group typing.
Ethical approval statement
Study was approved by Sumandeep Vidyapeeth Institutional Ethics Committee.
We are thankful to Dr. Hanee Patel, MBBS graduate from SBKS MIRC, SVDU who helped us for data collection. We are very much thankful to all participants who joined this survey and give their correct information to reach this level of knowledge.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]