ACADEMIA Letters Why COVID-19 Human Challenge Trial Protocol is Provocative and Controversial? PROF. DR. ABDUL ROB, Metropolitan University, Sylhet, Bangladesh ABDUL HOQUE ASM IFTEKHAR UDDIN MIAH MD ASADUZZAMAN AHSAN HABIB TAHMID ABDULLAH CHOWDHURY 1.0 INTRODUCTION: Coronavirus infection is notoriously difficult to treat. COVID-19 is truly pandemic affecting as of today 18th of March 2021, over 121 million people world-wide with nearly 2.68 million deaths [1]. All over the world, researchers are looking for a way of treating this novel infection. Various means are explored including drug evaluation, vaccine development and supportive therapy to eliminate the coronavirus. 2.0 IDEAL METHOD: The best protocol is to find an effective vaccine against COVID-19 infection. Various reports indicate a number of COVID-19 vaccine have been developed such as Oxford Uni AstraZeneca, Moderna, Pfizer Biotech, Gamalyeya etc [2]. Some of these vaccine already passed medical ethic committee and started to be used for human vaccination. For example, as of today, UK has vaccinated over 21 million people and Academia Letters, July 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: PROF. DR. ABDUL ROB, abdulrob@metrouni.edu.bd Citation: Rob, P.D.A., Hoque, A., Uddin, A.I., Asaduzzaman, M.M., Habib, A., Chowdhury, T.A. (2021). Why COVID-19 Human Challenge Trial Protocol is Provocative and Controversial? Academia Letters, Article 2087. https://doi.org/10.20935/AL2087. 1 likewise USA has vaccinated over 100 million [3]. This is extremely good news. But, how should a COVID-19 vaccine be evaluated before mass immunisation worldwide? 3.0. CONTROVERSIAL: HUMAN CHALLENGE TRIAL The technique commonly used for new vaccine evaluation is by immunising a large number of individuals and equating their infection frequencies to those from a population of unimmunised participants. This means the vaccine needs to be tested on a large number of volunteers. Also, there may be a long waiting period for the vaccinated person to become infected by the virus naturally to see if the inoculated vaccine is effective. Can we wait a long period in the current COVID-19 pandemic? The short answer to this question is ‘no’, so fortunately there is a faster protocol available which involves vaccinating healthy persons and then intentionally rendering them to the coronavirus virus infection. This is known as ‘human challenge trial’. Is ‘human challenge trial’ ethical? The short answer to this question is no, because it is regarded as provocative and controversial as the volunteers are deliberately put in the path of the virus [4]. However, as everyone is aware that the coronavirus pandemic problem is huge so in our opinion the volunteer need not to be too resistant in decision making provided various safety criteria are met as outlined by World Health Organisation (WHO). The safety criteria are to ensure that the volunteers remain healthy during the trial period. 4.0 EVIDENCE EVALUATION: So, our advice, if anyone is willing to volunteer is to be aware that if something goes wrong they are fully knowledgeable before participating in the experiment. Fortunately, the research group is expected to follow best practice protocol to know if the correct subject with all the quality needed is included in the study. Typically, the volunteer needs to be a healthy subject within a certain age group. Detailed Direction from the WHO clearly articulates guidelines for potential individuals participating in vaccine experiments. This is very important in our opinion for everyone to understand. Academia Letters, July 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: PROF. DR. ABDUL ROB, abdulrob@metrouni.edu.bd Citation: Rob, P.D.A., Hoque, A., Uddin, A.I., Asaduzzaman, M.M., Habib, A., Chowdhury, T.A. (2021). Why COVID-19 Human Challenge Trial Protocol is Provocative and Controversial? Academia Letters, Article 2087. https://doi.org/10.20935/AL2087. 2 5.0 DECISION AND GUIDELINES: As per guidance of the WHO, prior to engaging in the COVID-19 vaccine research the individuals must know the scientific justification, aware of risks assessment, conscious of potential benefit, looked into detailed consultation study and see the full volunteer engagement criteria. If the recommendation is strictly followed then there is a good chance of being a decent volunteer with perhaps minimum reaction and side effect. We expect that the majority of the people reading this article will be volunteering in the ‘human challenge trial’ to assist in discovering of COVID-19 vaccine and will find our opinion very useful. Unfortunately, no one can be sure if nasty reactions can occur during the vaccine experimental stage on the participating volunteers. At the current instant, ‘human challenge trial’ involves introducing selected volunteers in the path of the live virus, rather than expecting unintentional exposure. Our research of all publications indicates that none of the research groups can give any guarantee that the volunteer will be safe from ‘human challenge trial’. 6.0 CONCLUSION: Our recommendation to the future ‘human challenge trial’s ’ volunteer is to follow strictly WHO guidelines. By participating in the vaccine trial , you will assist in the discovery of COVID-19 effective vaccine. References 1. COVID-19 CORONAVIRUS PANDEMIC, Available at: https://www.worldometers. info/coronavirus/?utm_campaign=homeAdUOA?Si , Accessed:18 March 2021). 2. More than 25 million people in the UK have received their first dose of a COVID19 vaccine. Available at: https://www.gov.uk/government/news/more-than-25-millionpeople-in-the-uk-have-received-their-first-dose-of-a-covid-19-vaccine Accessed:18 March 2021). 3. U.S. reaches COVID-19 vaccine milestone of 100 million shots, Available at:https:// www.cbsnews.com/news/covid-vaccine-100-million-shots-united-states/ (Accessed:18 March 2021). Academia Letters, July 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: PROF. DR. ABDUL ROB, abdulrob@metrouni.edu.bd Citation: Rob, P.D.A., Hoque, A., Uddin, A.I., Asaduzzaman, M.M., Habib, A., Chowdhury, T.A. (2021). Why COVID-19 Human Challenge Trial Protocol is Provocative and Controversial? Academia Letters, Article 2087. https://doi.org/10.20935/AL2087. 3 4. Three reasons why Covid-19 challenge trials are so controversial The UK could host the world’s first Covid-19 challenge trial - an idea that leaves some doctors uncomfortable, Available at: https://www.telegraph.co.uk/health-fitness/body/three-reasons-covid-19challenge-trials-controversial/ (Accessed:18 March 2021). Academia Letters, July 2021 ©2021 by the authors — Open Access — Distributed under CC BY 4.0 Corresponding Author: PROF. DR. ABDUL ROB, abdulrob@metrouni.edu.bd Citation: Rob, P.D.A., Hoque, A., Uddin, A.I., Asaduzzaman, M.M., Habib, A., Chowdhury, T.A. (2021). Why COVID-19 Human Challenge Trial Protocol is Provocative and Controversial? Academia Letters, Article 2087. https://doi.org/10.20935/AL2087. 4