The Immunogenicity and Safety of the CHADOX1 nCoV-19 Vaccine

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Table of Contents

Introduction
Discussion
Conclusion
References

Introduction

The study used for this evaluation is a randomized, double-blind, placebo-controlled experiment designed to evaluate the immunogenicity and safety of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2 in South Africans with and without HIV. Findings showed that ChAdOx1 nCoV-19 was well accepted and that it was safe and immunogenic in HIV-positive individuals, with SARS-CoV-2 baseline-seropositive subjects demonstrating increased immunogenicity (Madhi et al., 2021). From Angell’s and Brody’s perspectives, the purpose of this answer is to determine if this study is morally acceptable.

Discussion

According to Angell (2010), randomized clinical trials are only morally acceptable when researchers are in a condition of equipoise or when there is no reasonable basis for concluding that one seems to be superior to the other. Given the number of vaccinations that have received medical society approval, from Angell’s standpoint, this placebo-controlled experiment can be ethically defensible. Angell (2010) concludes that “subjects in the control group of the study must receive the best-known treatment”(p. 293). Angell (2010) as well states that the Declaration of Helsinki mandates that control participants get the “best” ongoing medication, not the localized one. In response to this concern, the AstraZeneca vaccination used in this study has been authorized for use in more than 180 nations and is therefore applicable not only to the South African context (Li et al., 2022).

According to Brody (2010), unless specific requirements about future availability in the relevant nation are satisfied, placebo trials are exploitative. Brody (2010) asserts that using placebo control groups is morally acceptable as long as no participants were denied “any treatment that should otherwise be available to him or her” (p. 297). Since SARS-CoV-2 vaccinations are being distributed internationally to prevent COVID-19, the further availability of the prescribed medication is guaranteed within the boundaries of the trial (Madhi et al., 2021).

Conclusion

To conclude, the study was particularly significant because little is known about the safety and immunogenicity of COVID-19 vaccinations in this group, which makes up more than 80% of the world’s HIV-positive population (Madhi et al., 2021). Therefore, Brody would find this trial justifiable in terms of significance and access to the treatment and would not find the study exploitative by any means.

References

Angell, M. (2010). The ethics of clinical research in the third world. In Bioethics: Principles, Issues, and Cases (pp. 293–296). Oxford University Press.

Brody, B. (2010). Ethical issues in clinical trials in developing countries. In Bioethics: Principles, Issues, and Cases (pp. 297–301). Oxford University Press.

Li, G., Cappuccini, F., Marchevsky, N. G., Aley, P. K., Aley, R., Anslow, R., Bibi, S., Cathie, K., Clutterbuck, E., Faust, S. N., Feng, S., Heath, P. T., Kerridge, S., Lelliott, A., Mujadidi, Y., Ng, K. F., Rhead, S., Roberts, H., Robinson, H.,… & Bristol Clinical Research Nurse Team. (2022). Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6–17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial. The Lancet, 399(10342), 2212–2225.

Madhi, S. A., Koen, A. L., Izu, A., Fairlie, L., Cutland, C. L., Baillie, V., Padayachee, S. D., Dheda, K., Barnabas, S. L., Bhorat, Q. E., Briner, C., Aley, P. K., Bhikha, S., Hermanus, T., Horne, E., Jose, A., Kgagudi, P., Lambe, T., Masenya, M.,… & Kwatra, G. (2021). Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomised, double-blind, placebo-controlled, phase 1B/2A trial. The Lancet HIV, 8(9), e568–e580.

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The Immunogenicity and Safety of the CHADOX1 nCoV-19 Vaccine

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