Some reflections on vaccine research ethics during COVID-19 pandemic.

As of 15 December 2020, 52 candidate vaccines are under clinical evaluation for novel COVID-19 and one vaccine has received emergency use authorisation.1 2 However, vaccine research ethics is evolving and finding urgent solutions becomes paramount. In this article, we highlight such ethical issues in the vaccine trials especially those being faced by low-middle-income countries (LMIC). 1. Review by institutional ethics committees (IECs) Even after months of pandemic, IECs in LMIC are finding it difficult to balance increasing number of clinical trials with timely review. Political pressure and unusual circumstances are compelling expedited reviews and approvals of seamless phase 1/2 and 2/3 trials. Although these processes provide early access to market, cutting short on vaccine development from 10 to 15 years to 10 to 18 months might compromise safety. Besides, assessment of ethical standards of new trial designs and ways adopted for data capture, recruitment and follow-up during pandemic requires time and vigilance and should not be hurried through. For instance, some sponsors are omitting the clause, ‘the participant should not have participated in any clinical trials within the last 3 or 6 months’, from the exclusion criteria,3 4 that is leading to co-enrolment of participants in multiple trials and acceptance of multiple payments for participation, which violate ethics in research. 2. Research conduct Smart devices are increasingly being used to address subject recruitment and follow-up during lockdowns. …