COVID-19 vaccination in the Indian blood donors: Adjudging the impact on the deferral period.

The only efficacious way to provide people with herd immunity against the novel corona virus [nCoV] is to administer an appropriate vaccine and help check the current pandemic. With the genetic sequence data of the nCoV already available since January 10, 2020, leading pharmaceutical companies, world over, in turn, have started working on the clinical trials to produce vaccines against this nCoV. In fact, many vaccines under the Phase III trial have claimed to demonstrate their efficacy to be as high as 95% against the nCoV. In January, the central drugs standard control organization, India had granted the emergency-use authorization [EUA] to two vaccines namely, Covishield (live vaccine, Oxford-AstraZeneca, United Kingdom being manufactured by the Serum Institute of India, Pune) and Covaxin (inactivated vaccine, Bharat Biotech, India). Although, most of the countries offer no deferral period for the donors who have been administered an inactivated vaccine against this nCoV. However, the national blood transfusion council of India has recently recommended a donor deferral period of 28 days from the last dose of vaccination. This could essentially lead to a massive loss of eligible blood donors and jeopardize the already disrupted blood supply management due to the COVID-19 outbreak. The authors, herein, propose a thorough redefining of this deferral period post-vaccination amongst the Indian blood donors.

Sir,

In December 2019, a novel coronavirus [nCoV] was reported from Wuhan, China [1]. This nCoV is known to cause coronavirus disease 2019 [COVID-19], which has been renamed as Severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]. Further, the only effective way to provide people with immunity against SARS-CoV-2 is to discover and produce an appropriate vaccine for developing herd immunity to end the current pandemic of COVID-19. With the genetic sequence data of the nCoV already available since January 10, 2020, leading pharmaceutical companies, the world over, in turn, have started working on the clinical trials to produce vaccines against this nCoV. In fact, many vaccines under the Phase III trial have claimed to demonstrate their efficacy to be as high as 95% against the nCoV. In January, the central drugs standard control organization, India had granted the emergency-use authorization [EUA] to two vaccines namely, Covishield (live vaccine, Oxford-AstraZeneca, United Kingdom being manufactured by the Serum Institute of India, Pune) and Covaxin (inactivated vaccine, Bharat Biotech, India). The major difference between these two vaccines is that the Covishield is a live vaccine while Covaxin is an inactivated vaccine. The ultimate aim of blood transfusion services [BTS] is to provide blood that is safe for transfusion. In fact, the pre-donation donor screening is the first and the most important step to ensure the safety of the blood supply. Indeed, screening before donation is the first and most important step in ensuring the safety of the blood supply. This involves the use of a donor questionnaire and a mini-physical examination to ensure both donors as well as the recipient's safety. Blood from a recently vaccinated donor with a live vaccine may contain an infective agent, which can theoretically be transmitted through blood transfusion especially in immunocompromised recipients. Therefore, the World health organisation (WHO) recommends a donor deferral of 28 days after live vaccination [2]. However, killed vaccines do not pose any risk to the recipient of blood and therefore the donor can be accepted for donation without any deferral period. In India, as per amendment in the Drugs and Cosmetics Act, 2020, a temporary deferral of 14 days is recommended for donors with a history of non-live vaccination and 28 days for donors with a history of live vaccination [3]. The national blood transfusion council of India (NBTC) has recently recommended a donor deferral period of 28 days after vaccination against COVID-19 [4]. Depending upon the type of vaccine administered against COVID-19, different countries have adopted different deferral periods [5], [6], [7], [8], [9], [10] as enlisted in Table 1 . Most of the countries offer no deferral period for the donors who have been administered an inactivated vaccine against COVID-19. However, as per the current protocol in India, both Covishield and Covaxin have a 2-dose regimen, in which the doses are administered 4 weeks apart. Therefore, anyone undergoing vaccination against COVID-19 is essentially deferred for 28 days after the last dose. Now, based on priorities for the high-risk groups of infection and transmission, such as elderliness, healthcare workers, taskforce distribution phase plans, including the government commitment, we have an upcoming mass vaccination program to roll out in India. Hence, the deferral period of 28 days from the last dose could essentially result in a massive reduction in the number of eligible blood donors. This will further compromise the blood supply management, which has already been disrupted due to the COVID-19 pandemic itself [11].

Table 1

Donor deferral period after COVID-19 vaccination practiced in different countries.

Name of the country	Donor deferral after live COVID-19 vaccine	Donor deferral after inactivated COVID-19 vaccine
USA [5]	14 days	Nil
UK [6]	28 days	7 days
Canada [7]	Nil	Nil
European Union [8]	28 days	Nil
Australia [9]	7 days	7 days
Singapore [10]	28 days	3 days
India [4]	28 days	28 days

Additionally, the primary route of transmission of COVID-19 is the respiratory route [12], [13]. No case of transfusion-transmitted COVID-19 case has been reported thus far. In fact, in a reported case, a recipient was transfused platelet concentrate obtained from a confirmed case of COVID-19 donor and still, the recipient remained negative for the COVID-19 disease [14]. Therefore, in line with current scientific data, the risk of transfusion transmission of COVID-19 is only theoretical. Consequently, the 28-day deferral period adopted by NBTC in India is not only unjustified but also unacceptable. Therefore, we propose a thorough review and modifications of the same, bearing in mind, the discussion with the experts in order to frame an effective strategy, both for now as well as a measure of pandemic preparedness for future use [15]. Another area that warrants immediate attention is the effectiveness of these two vaccines against emerging new variants of nCoV such as, 501Y.V2 (South Africa) and B.1.1.7 (United Kingdom).

Research involving human participants and/or animals

Human participants.

Informed consent

As per our department policy an informed consent is obtained from all the donors prior to their whole blood donation in accordance to our standard operating protocol.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Funding

No funding was received for this study.

Authors’ contributions

Naveen Bansal contributed to the literature search, data compilation, manuscript preparation, editing and review, while Manish Raturi contributed to the conceptual design, literature search, manuscript preparation, editing, review as well as being the guarantor who takes the complete responsibility for the integrity of the work done as a whole right from it's inception to the published article.

Disclosure of interest

The authors declare that they have no competing interest.