Immunological surrogate endpoints of COVID-2019 vaccines: the evidence we have versus the evidence we need

Signal Transduct Target Ther. 2021 Feb 2;6(1):48. doi: 10.1038/s41392-021-00481-y.


In response to the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, over 200 vaccine candidates against coronavirus disease 2019 (COVID-2019) are under development and currently moving forward at an unparalleled speed. The availability of surrogate endpoints would help to avoid large-scale filed efficacy trials and facilitate the approval of vaccine candidates, which is crucial to control COVID-19 pandemic. Several phase 3 efficacy trials of COVID-19 vaccine candidates are under way, which provide opportunities for the determination of COVID-19 correlates of protection. In this paper, we review current knowledge for existence of COVID-19 correlates of protection, methods for assessment of immune correlates of protection and issues related to COVID-19 correlates of protection.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Biomarkers
  • COVID-19 Vaccines* / immunology
  • COVID-19 Vaccines* / therapeutic use
  • COVID-19* / immunology
  • COVID-19* / prevention & control
  • Clinical Trials, Phase III as Topic
  • Humans
  • Pandemics / prevention & control*
  • SARS-CoV-2 / immunology*


  • Biomarkers
  • COVID-19 Vaccines