Ethical Issues and Regulatory Challenges ABOUT THE LEAD AUTHOR Professor Narinder Kumar Mehra, FNA, FNASc, FTWAS, is the former Dean ABOUT THE BOOK (Res) and National Chair of the prestigious All-India Institute of Medical Sciences HOST IMMUN Professor Narinder Mehra is the Honorary Emeritus scientist (AIIMS) New Delhi and currently holds the Honorary position as Emeritus scientist of the Indian Council of Medical Research. He is an internationally acclaimed expert The COVID-19 pandemic has emerged as a serious of ICMR, and former Dean and National Chair of the All-India in the area of Transplant Immunology and Clinical Immunogenetics and is credited human and health crisis affecting over 115 million lives Institute of Medical Sciences, New Delhi. He is an internationally with establishing the speciality for the first time in India. He is a Fellow of several acclaimed expert in the area of Transplant Immunology science academies including the Indian National Science Academy (FNA), National globally with adverse impact on the world economy, and Clinical Immunogenetics, for which his singular efforts Academy of Sciences India (FNASc), Member Honoris Causa of the Hungarian food security, nutrition and life in general. The culminated in establishing this specialty for the first time in Academy of Sciences and ‘Fellow’ of The World Academy of Sciences (FTWAS). disease caused by the novel human beta coronavirus, A recipient of the S.S. Bhatnagar award (1992000), he has over 100 awards to his India, thus facilitating solid organ and hematopoietic stem cell credit and was also honoured with the ‘French Chevalier National Order of Merit’. SARS-CoV-2 has attracted so much attention of the transplants in the country. He has published over 480 research papers in leading international journals. governments and people globally that no other disease His research focus has been on defining biomarkers of disease Dr. Sanjay Madhav Mehendale, MD, MPH, FAMS, served in National Institute I has done in recent times. It is a stark reminder of susceptibility in infectious and autoimmune diseases, influence of Virology (1986-92), National AIDS Research Institute (1992-2010), National TY AND VACC HOST IMMUNITY the ongoing challenge of emerging and re-emerging of HLA matching and alloantibodies on transplant injury, stem Institute of Epidemiology (2010-2016 as Director), National Institute for Research in infectious pathogens and the need for maintaining cell biology and regenerative medicine among others. He played Tuberculosis (2017-18 as Director-in-Charge) before becoming Additional Director- General of the Indian Council of Medical Research. Currently, he is the Director AND constant surveillance through dedicated research efforts an important role in preparing National guidelines for stem cell (Res) at P.D. Hinduja Hospital and Medical Research Centre in Mumbai. He has to understand the basic biology of new organisms and research in India. more than 200 publications to his credit. His areas of research interest include epidemiology of infectious diseases, public health and health systems research, human susceptibilities to them. The observed novel Professor Mehra has been the President of the Indian Immunology clinical trials and socio-behavioural research. He led the first Phase I trials of HIV mutations in the virus suggests that it is still evolving Society, councilor for the International Union of Immunological vaccines in India. VACCINES and may not yet been fully adapted to the human host. Societies, co-chair of the IUIS Gender equality committee and founder Secretary-General of the Federation of Immunological Nevertheless, the recent turn of events provide a new Societies of Asia-Oceania. He is a Fellow of the Indian National hope of ending the global pandemic by achieving I Science Academy, National Academy of Sciences, National NES FOR community immunity through both natural infection as Academy of Medical Sciences, Member Honoris Causa of the well as vaccines. People must continue to observe virus Hungarian Academy of Sciences and ‘Fellow’ of The World Dr. Gaurav Sharma is Assistant Professor in the Department of Translational appropriate behaviour in their day-to-day lives and help and Regenerative Medicine at the Post-Graduate Institute of Medical Education Academy of Sciences (FTWAS). He served as chief Editor of break the cycles of new infection and disease. ‘Frontiers in Immunology’ special issue on ‘Clinical relevance and Research, Chandigarh. His expertise includes histocompatibility and of antibodies in solid organ transplantation’. immunogenetic analysis in relation to solid organ and hematopoietic stem cell transplantation, investigating biomarkers for infectious and autoimmune diseases, This white paper is a tribute to the unprecedented Professor Mehra has nearly 100 awards and academic honors to and research in regenerative medicine. zeal and enthusiasm of the scientific community and of his credit. Some of the significant ones include S.S. Bhatnagar CO A WHITE PAPER the medical professionals working together with the Award of the Council of Scientific and Industrial Research, single most objective of defeating the deathly pandemic. Ranbaxy Science Foundation Award, O.P. Bhasin Science VI Professor Narendra Kumar Arora, MD is the Executive Director of The INCLEN It is a comprehensive treatise with focus on host Foundation Award, Chief of the Army Staff Award and Dr B.R. D Trust International, a ‘not for profit’ organization fostering research and training immunity, vaccines and ethical aspects of COVID-19. Ambedkar award of ICMR for excellence in Medical Research. -19 – to address global health challenges. He is the former Professor of Pediatrics, All The book has 8 chapters, written in easy-to-understand In 2003, the French President, conferred on him the title of India Institute of Medical Sciences, New Delhi, Chair of the National COVID-19 format. ‘Chevalier of the National Order of Merit’. He also received Working Group (NTAGI), CO-Chair of the Independent Allocation Group of COVID- Prof. Narinder K Mehra, FNA the highest International Award from the Iranian Research 19 Vaccine (WHO). He is extensively involved in policy-making, program planning, implementation and evaluation. He has published extensively in the area of public The year 2021 brings in new challenges for the Organization for Science and Technology. He was a member of A health. health authorities of vaccinating the huge population, the international jury for the Else Kroner Fresenius International W bringing hope and confidence that life will return to Award in Immunology and CIHR-IRF joint research projects. HI normal sooner than later. India becomes the greatest Professor Mehra and his group have published more than 480 TE PA success story in the fight against the pandemic and original research papers in leading international journals. His book ‘The HLA System in Medicine and Biology’ received high emerges as one of the only five nations globally to AL SCIEN ON C TI E P A A produce indigenously manufactured vaccines against international acclaim. He has trained 40 Ph.Ds. and more than N C A N D ER is a researcher based in Bhopal with expertise in global health, A E Dr. Anant Bhan I 50 MD/MS postgraduates in the area of clinical Immunogenetics M INDIAN NATIONAL SCIENCE ACADEMY the coronavirus. D Y Y N N I and Transplant Immunology bioethics and health policy. He is an immediate past president of the international I association of bioethics and is an adjunct faculty with the Kasturba Medical college, Bahadur Shah Zafar Marg Manipal. New Delhi-110002 AL SCIEN ON C TI E A A N C A N D A E I M D Y Y N N I I 137 à ~ ; e kf s.; e qoZj HkxZ% lfor à ~ ; e kf s.; e qoZj HkxZ% lfor HOST IMMUNITY AND VACCINES COVID-19 A WHITE PAPER Narinder K. Mehra Sanjay M. Mehendale Gaurav Sharma Narendra K. Arora Anant Bhan AL SCIEN ON C TI E A A N C A N D A E I M D Y Y N N I I INDIAN NATIONAL SCIENCE ACADEMY Bahadur Shah Zafar Marg, New Delhi-110002 à ~ ; e kf s.; e qoZj HkxZ% lfor Citation: Host Immunity and Vaccines for COVID-19 – A White Paper, Indian National Science Academy, New Delhi. pp i-xx and 1-136 © INDIAN NATIONAL SCIENCE ACADEMY E-mail : [email protected], [email protected] Fax : +91-11-23231095, 23235648 EPABX : +91-11-23221931-23221950 (20 lines) Website : www.insaindia.res.in; www.insa.nic.in (for INSA Journals online) INSA Fellows App: Downloadable from Google Play store AUthORS’ AffiliatiOns: Narinder K. Mehra: Hon. Emeritus Scientist of Indian Council of Medical Research and Former Dean and National Chair, All India Institute of Medical Sciences, New Delhi (narin. [email protected]) Sanjay M. Mehendale: Director-Research, PD Hinduja Hospital and Medical Research Centre, Mumbai ([email protected]) Gaurav Sharma: Assistant Professor, Department of Translational and Regenerative Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh (sharma.gaurav@pgimer. edu.in) Narendra K. Arora: Executive Director, International Clinical Epidemiology Network (INCLEN), New Delhi ([email protected]) Anant Bhan: Researcher, Global Health, Bioethics and Health Policy, Bhopal, Madhya Pradesh ([email protected]) Vice-President (Publications/Informatics) Dr. Amit Ghosh, FNA Production Dr. Sudhanshu Aggarwal Published by Dr. Amit Ghosh, Vice-President (Publications/Informatics) on behalf of Indian National Science Academy, Bahadur Shah Zafar Marg, New Delhi 110002 and printed at Angkor Publishers (P) Ltd., B-66, Sector 6, NOIDA-201301; Tel: 0120-4112238 (O); 9910161199, 9871456571 (M) MkW- fouksn dqekj ikWy Hkkjr ljdkj lnL; uhfr vk;ksx] laln ekxZ Dr. Vinod K. Paul ubZ fnYyh&110 001 Government of India MEMBER lR;eso t;rs NATIONAL INSTITUTION FOR TRANSFORMING INDIA NITI Aayog, Parliament Street New Delhi-110 001 Tele.: 23096809/23096820; Fax: 23096810 E-mail: [email protected] FOREWORD Viruses are older than the mankind and are more numerous than all other forms of life put together.