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Vaccines, convalescent plasma, and monoclonal antibodies for covid-19

BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m2722 (Published 09 July 2020) Cite this as: BMJ 2020;370:m2722

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India’s COVID-19 vaccine attempts: A ray of hope and need for caution

Dear Editor,
The ongoing pandemic of Coronavirus disease-2019 (COVID-19) has threatened millions of lives globally. An effective vaccine against COVID-19 is need of the hour. India has been a hub for vaccine productions and Indian pharmaceutical companies have contributed immensely to the vaccine related projects running all over the world. Indian companies have also been pioneers in starting working on COVID-19 vaccine and finishing preclinical trials1. Recently, two indigenous COVID-19 vaccines, Covaxin by Bharat Biotech and ZyCoV-D by Zydus, Cadila, have got regulatory approval to enter Phase I/II human clinical trials1. COVID-19 cases are surging fast in India, hence the commencement of the clinical trials for the vaccine has raised great hope and brought a sense of relief in the common people. However, as any proposed viral vaccine may have important safety risks for the clinical trial participants, and subsequent users, related issues have now come to the fore.
It has been a global understanding among medical institutions and research organizations that sticking to the guidelines set by World Health Organization (WHO) for human clinical trials for any vaccine is a must2, and any haste in that may be risky. Also, keeping to the standard ethical principles in selecting clinical trial participants, following up for the adverse effects, taking due care of their safety, and eligible scrutiny of the trial results are the mandatory concerns which cannot be overlooked. It is also necessary that the health centres chosen for the vaccine trial should have prior experience in running clinical trials2.
Surprisingly, Indian Council of Medical Research (ICMR), the top medical research regulatory body of the country, has asked participating health centres for setting a target completing all three phase clinical trials for Covaxin until 15th August, 20203,4. Covaxin has been developed in partnership with ICMR’s National Institute of Virology (NIV). The hastened approach by the regulatory body has astonished medical experts, biological scientists, and scientific organizations of the country 4 . However, later, the regulatory body has clarified on the issue and said that it was only an attempt to fast track the process, and any deadline has not been fixed. The organization has also assured that the quality of the vaccine and participant’s safety will not be compromised5. We hope that, hereafter the standard operative procedures will be followed and participants’ safety will remain a priority for the COVID-19 vaccine clinical trials in the country.

References
1. India approves second Covid-19 vaccine for clinical trials [Internet]. [cited 2020 Jul 6];Available from: https://www.clinicaltrialsarena.com/news/india-trials-second-covid19-vac...
2. WHO Expert Committee on Biological Standardization Sixty-seventh report /Guidelines on clinical evaluation of vaccines: regulatory expectations. https://www.who.int/biologicals/expert_committee/WHO_TRS_1004_web_Annex_...
3. Bharat Biotech ICMR [Internet]. [cited 2020 Jul 6];Available from: https://www.scribd.com/document/467859231/Bharat-Biotech-ICMR#download&f...
4. India’s Foremost Science Academy Calls ICMR’s August 15 Vaccine Deadline “Unfeasible” [Internet]. [cited 2020 Jul 6];Available from: https://thewire.in/science/indian-academy-of-sciences-covid-19-vaccine-i...
5. ICMR press release, July 4, 2020. [cited 2020 Jul 6];Available from: https://www.icmr.gov.in/pdf/press_realease_files/ICMR_Press_Release_0407...

Competing interests: No competing interests

15 July 2020
Ashutosh Kumar
Assistant Professor
Ravi K. Narayan, All India Institute of Medical Sciences (AIIMS), Patna, India; Kamla Kant, All India Institute of Medical Sciences (AIIMS), Bathinda, India; Cheena Kapoor, A freelance health science reporter based at New Delhi, India
All India Institute of Medical Sciences (AIIMS), Patna, India
Patna, Bihar, India