| Abstract|| |
BACKGROUND: Blood transfusion is an integral part of the health-care system. A healthy donor is important for safe blood transfusion. Donors are selected based on the deferral criteria given by the Drugs and Cosmetics Act 1940 and amended thereof. Coronavirus disease 2019 (COVID-19) vaccination became mandatory after the spread of COVID-19 pandemic and was included in the deferral criteria.
OBJECTIVE: The objective was to study and analyze the impact of COVID-19 vaccination on the deferral pattern in blood donors.
MATERIALS AND METHODS: A retrospective study was carried out in the Department of Immunohematology and Blood Transfusion for pre-COVID period from January 2019 to December 2019 for the most common reason of deferral before COVID-19 and for comparison for donor deferral with COVID-19 period. Then, a retrospective study was carried out over a period of 12 months from February 2021 to January 2022. The demographic details of donors such as age, gender, voluntary or replacement donation, and temporary and permanent reasons for deferral were recorded. The data were entered in the MS Excel sheet and descriptive statistics were calculated.
RESULTS: The total numbers of registered donors were 7064. Six thousand two hundred and sixty-four donors were accepted for donation, of which voluntary donations were 4478 (71.48%). The deferred donors were 800 (11.3%). Seven hundred and thirty-eight (92.26%) deferred donors were male; the most common cause of temporary deferral was COVID-19 vaccination 179 (22.37%), followed by low hemoglobin 162 (20.25%). The common causes of permanent deferral were high blood pressure 36 (5.17%) and history of unknown jaundice 10 (1.43%).
CONCLUSION: COVID-19 vaccination had a significant impact on the pattern of donor deferral. However, this was only a temporary situation till the pandemic is over. The loss of potential donors has adversely impacted the transfusion services.
Keywords: Blood center, coronavirus disease 2019, donor deferral, temporary causes
|How to cite this URL:|
Jain H, Singh B, Mittal A. Impact of coronavirus disease 2019 vaccination on donor deferral pattern in a tertiary care hospital of ESIC, New Delhi. Asian J Transfus Sci [Epub ahead of print] [cited 2023 Mar 30]. Available from: https://www.ajts.org/preprintarticle.asp?id=363240
| Introduction|| |
Novel coronavirus disease 2019 (COVID-19) is caused by coronavirus leading to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first case of SARS-CoV-2 was reported from Wuhan, China, in late 2019, and within the next few months, it had spread to 213 countries including India. The incubation period ranges from 1 to 14 days. A period of lockdown was implemented in India from March 25, 2020, to prevent the spread of infection. The vaccination drive for COVID-19 started on January 16, 2021, with vaccine either “Covaxin” or “Covishield.” The first phase of vaccination was done for population of above 18 years. As vaccination was done on a large scale, the Indian Council of Medical Research (ICMR) and the National Blood Transfusion Council recommended a deferral period of 14 days after COVID-19 vaccination with any type of vaccine for blood donation. The Drugs Controller General of India also accepts the recommendation. Therefore, recruitment of voluntary, safe, and healthy blood donors for the provision of quality blood products to needy patients during the COVID-19 pandemic, became a constant challenge for the blood transfusion services, due to the depletion of potential blood donors.
| Materials and Methods|| |
It was a retrospective study, conducted at ESI Postgraduate Institute of Medical Science and Research Centre and Model Hospital , Blood Centre, for a period of 12 months from February 2021 to January 2022. This study was compared with the data of pre-COVID period from January 2019 to December 2019. All blood donors were screened as per the recently amended Blood Centre Rule, Schedule F, Part XII B of the Drugs and Cosmetic Act 1940. All voluntary and replacement, nonremunerated, whole-blood donors recruited at blood center and outdoor camps were included in the study. All blood donors were registered and screened.
Each donor was evaluated by the donor questionnaire. Medical examination was done, hemoglobin (Hb) was estimated by cyanmethemoglobin method using Drabkin's solution, and age, body weight, blood pressure (BP), pulse, and temperature were noted. Cutoff value and range of the above mentioned parameters for donor acceptance included Hb >12.5 g/dl, body weight more than or equal to 45 kg, systolic BP 100–140 mmHg, diastolic BP 60–90 mmHg, and age 18–65 years.
The donor deferral period for COVID vaccination was taken as 14 days as per the ICMR guidelines. However, the National Blood Transfusion Council of India has considered 14 days both for live and nonlive vaccines. However, the American Association of Blood Banks has considered 14 days of donor deferral for live vaccine and nil donor deferral for nonlive vaccine, and the Australian Red Cross Lifeblood has considered a 7-day donor deferral for both to meet the challenge. The questionnaire and health condition were evaluated by the medical officer of blood center who certified the fitness of the donors for blood donation. The deferred donors were categorized into temporary and permanent. Temporary deferred donors were counseled to become future regular blood donors. The data were retrieved from the donor deferral record and details were entered in the MS Excel sheet and descriptive statistics were calculated.
| Results|| |
A total of 7064 potential blood donors were registered during the COVID period for donation during the study period of 12 months from February 2021 to January 2022. Out of 7064 registered donors, 6264 donors were accepted for donation, of which 4478 (71.48%) were voluntary donations and 1786 (28.51%) were replacement donations. A total of 6212 were accepted for donation during the pre-COVID period, of which 3364 (54.15%) were voluntary donors and 2848 (45.84%) were replacements, as shown in [Table 1].
|Table 1: Gender-wise distribution of donors based on type of donation (voluntary/replacement)|
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Out of 7064 registered donors, 6264 (88.67%) donors were accepted for donations and 800 (11.3%) were deferred. Of 6264 accepted blood donors, 6208 (99.10%) were male and 56 (0.89%) were female. Out of 800 deferred donors, 738 (92.25%) were male and 62 (7.75%) were female, as shown in [Table 2].
Majority of donor deferrals were due to temporary reasons 754 (94.25%) and 46 (5.75%) donors were permanently deferred, as shown in [Table 3]. The most common cause of temporary deferral was COVID-19 vaccination 179 (22.4%), followed by low Hb 162 (20.2%), alcohol intake within 24 h 122 (15.3%), and medical reasons 108 (13.5%) including typhoid, history of fever or infection, and skin allergy. Whereas during the pre-COVID period, the most common reason for temporary deferral was low Hb 335 (23.7%), followed by medical reasons 253 (17.9%) and other reasons which include lack of sleep, history of surgery, and phlebotomy failure [Table 3] and [Figure 1].
|Table 3: Distribution of temporary deferral causes in pre-COVID and COVID periods|
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|Figure 1: Pie-chart showing distribution of causes of temporary deferral for COVID peroid|
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The common causes of permanent deferral were high BP and cardiovascular disease 36 (5.17%) and history of unknown jaundice for COVID period and similar results were seen in pre-COVID period, as shown in [Table 4].
The deferred donors were also categorized according to age groups, as shown in [Table 5]. Majority of deferred donors were in the age group of 26–35 years (378/800) 44.50%, followed by the age group of 18–25 years (254/800) 31.75% and 36–45 years (94/800) 11.75%. The age group with maximum number of deferrals for permanent reasons such as high BP and cardiovascular system (CVS) disease was found in 36–45 years (15/36) 41.66% and for unknown jaundice was found in the age group of 26–35 years (5/10) 50%.
| Discussion|| |
Blood transfusion service is a vital part of health-care services. Blood donor deferral is a painful and sad experience for blood donor as well as blood donation center where meticulous screening of blood donor has been done. Moreover, deferring prospective donors often leaves them with negative feeling about themselves and about the blood donation process. Nonetheless, the implementation of strict deferral criteria strongly influences the quality of blood and blood components in blood center. The rate and reasons for deferral differ from region to region and from one center to another. The reported donor deferral rates in blood centers vary from 3.55% to 24% leading to huge losses in terms of available units for transfusion every year.
In our study, total donations were 6264, out of which voluntary donations were 4478 (71.48%) and replacement donations were 1786 (28.51%). Similar findings were seen in the study conducted by Agnihotri N et al, Jethani et al and Kulkarni N et al showing voluntary donors as 70.7%, 83.64% and 79% respectively and replacement donors were 29.3% ,16.36% and 21% respectively.
In this study, the deferral rate was 11.32%, which is in line with the donor deferral rate reported by Agnihotri (11.6%), Shrivastava et al. (11.5%), Ahmad et al. (12.6%), Routray et al. (12.74%), and Das (9.69%). In contrast, the quite low donor deferral rate has been reported by Unnikrishnan et al. (5.20%), Jethani et al. (2.56%), Kapse et al. (3.56%), and Kujur et al. (3.77%). A much higher deferral rate was seen in a study conducted by Alha et al. (18%), Taneja et al. (17.1%), and Al Shaer et al. (19.4%). The difference in the deferral rate seen in various studies across India could be because of geographical and socioeconomic differences.
In the present study, the majority of donors were male 99.32% and females contributed only 1.67%, which showed that the overall percentage of donations was majorly by males. Similar results were shown by Kujur et al. and Krishna et al.
We found the deferral percentage for males to be 11.88%, and for females, it was 52.54%. Similar results were seen in other studies conducted by Arun et al., Agrawal et al., and Chauhan et al. The possible explanation high percentage of female deferral is due to the high prevalence of iron deficiency in females in developing countries.
The total temporary deferrals in the present study were 754/800 (94.25%) and the most common cause was found to be COVID-19 vaccination (22.37%), followed by low Hb (20.25%). The highest deferral due to COVID-19 vaccination was because of the COVID-19 pandemic and therefore can be considered a temporary situation. The second most common cause for deferral was low Hb. In a similar study done by Routray et al. in Bhubaneshwar showed the most common cause of deferral during the COVID period as low HB, followed by COVID vaccination. When we compared our findings of Covid and Pre-Covid periods in the same centre , found low Haemoglobin as one of the major cause of temporary deferrals as shown in different studies. Other studies conducted by Sundar et al. and Bahadur et al. found temporary deferrals to be 84% and 91%, respectively, with anemia as the most common cause of deferral, followed by bodyweight <45 kg. Similar studies done by Kujur et al., Taneja et al., and Das also reported low Hb to be the most common cause for temporary deferral. In our study, alcohol consumption was the third most common cause of temporary deferral. Das S et al. found alcohol consumption (15.97%) to be the second most common cause of temporary deferral, followed by anemia (54.58%), as shown in [Table 6]. Permanent deferral in our study was 5.75% with high BP, and CVS diseases and history of unknown jaundice were found to be the most common reasons. Similar finding were seen in study conducted by Sunder P et al with Hypertension and history of jaundice as most common cause (9%) and Agnihotri N et al with High blood pressure(11.1%) as most common cause for permanent deferral.
|Table 6: Comparison of the most common causes of temporary deferral in various Indian studies|
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The maximum deferred donors were in the age of 26-35 years followed by 18-25years. Similar observation was made by Agnihotri and Routray et al. Other studies conducted by Agrawal et al., Shrivastava et al., Kandasamy et al., Ahmad et al., and Krishna et al. showed similar results. However, Arun et al. showed maximum deferral in the 46–55-year (337) age group.
This study was conducted during the COVID-19 pandemic. COVID-19 vaccination was made essential during the pandemic. A large number of donors came within 14 days of COVID vaccination which shows a changed pattern of deferral donors making vaccination the most common cause for temporary deferral. However, this variation effect is a temporary one, till COVID-19 pandemic is over. The most common cause of deferral is low heamoglobin.
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Department of Immunohematology and Blood Transfusion, ESIC Model Hospital, New Delhi - 110 015
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]