Criteria for judging the immune markers of COVID-19 disease vaccines.

As severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) sweeping the world, effective and affordable vaccines are in urgent need. A reliable system for the assessment of SARS-CoV-2 vaccines would boost the development of vaccines and reduce the research cost. We constructed a logistic regression model and analyzed the relationship between antibody (Ab) level and efficacy of different vaccine types. The relationship between assessment dates and Ab levels was depicted by plotting the mean of Ab levels evolved over time and a fitted cubic polynomial model. Anti-spike immunoglobulin G (IgG) could best estimate the vaccine efficacy (VE) (adjusted = 0.731) and neutralizing Ab to live SARS-CoV-2 also explained a fine relationship (adjusted = 0.577). Neutralizing Abs to live SARS-CoV-2 in inactivated virus vaccines reached a peak during days 40-60, and their receptor-binding domain (RBD)-IgG peaked during days 40-50. For messenger RNA (mRNA) and viral vector vaccines, their neutralizing Ab to live SARS-CoV-2 peaked later than day 40, and for RBD-IgG during days 30-50. For mRNA and viral vector vaccines, their peak time of Abs was later than that in inactivated virus vaccines. RBD-IgG peaked earlier than Ab to live SARS-CoV-2. Anti-spike IgG and Ab to live SARS-CoV-2 may be good immune markers for VE assessment.