Guidance on safety data collection for COVID-19 vaccine safety

A novel coronavirus (CoV), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), emerged in late 2019 in Wuhan, China and has since spread as a global pandemic. Safe and effective vaccines are urgently needed to reduce the significant morbidity and mortality of Coronavirus Disease 2019 (COVID-19) and ease the major economic impact. There has been an unprecedented rapid response by vaccine developers with >140 vaccine candidates in preclinical development and >20 having reached clinical trials. However, a major challenge during rapid development is to avoid safety issues both by thoughtful vaccine design and by thorough safety evaluation in a timely manner. This SO2 D2.4 deliverable was meant to summarize recommendations for vaccine safety data collection, CRF, presentation and analysis for clinical trials of CEPI funded vaccine candidates targeting COVID-19.

SPEAC has responded to this challenge by summarizing recommendations by the Brighton Collaboration and SPEAC project for vaccine safety data collection, CRF, presentation and analysis for clinical trials of CEPI funded vaccine candidates targeting COVID-19 with sample CRF presented in Appendix 1. In response to a request by CEPI to provide comments to the 19April version of the WHO Solidarity Protocol, SPEAC outlined the safety evaluations that should be included for trials of COVID-19 vaccine candidates with input from some Meta-DSMB members. As an example, we provided a memory aid for collection of solicited local and systemic reactions following immunization included as Appendix 2. A guide for presentation and analysis of these solicited local and systemic reaction data is included as Appendix 3 using the Brighton Collaboration case definitions as a reference where available. We also reviewed the information about enhanced disease following immunization with prior coronavirus vaccine candidates for SARS and MERS, establishing an initial literature search to gather the available information on this topic and then with the support of CEPI (Appendix 4), and organized a virtual 2-day consensus meeting on March 12 and 13, 2020 to review the preclinical data with a panel of experts. This meeting led to consensus recommendations for developers with the input of regulators attending the meeting that has been published and is included as Appendix 5.