Report of consultation is available HERE
The WHO R&D Blueprint organized a consultation to discuss emerging evidence towards the establishment of correlates of protection for COVID-19 vaccines.
Vaccine developers and researchers presented new data and current research plans. The consultation included deliberations on specific components of the immune response that may be correlated with clinical protection and trial and statistical methods to generate and analyse available evidence.
There is a need for robust data that would help to swiftly evaluate updated versions of available vaccines against the emerging strains and new vaccines against current and emerging variants. Immunobridging could contribute to the evaluation of modified vaccines, to accelerate bridging efficacy to additional populations and against variants of concern, and to better understand the duration of protection.
Invited experts included:
- Leading researchers on COVID vaccine studies
- Statisticians and clinical trial experts
- Vaccine developers
- Regulatory experts
Agenda is available HERE
Presentations
Session 1: EMERGING EVIDENCE
- RCTs reporting clinical endpoints for variants
- Observational studies reporting clinical endpoints for delta variant
- Efficacy and effectiveness against variants
- Overview of Human Challenge Studies
- Evidence on breakthrough infection and immunity (1) - Immune Correlates Analysis of the mRNA-1273 Vaccine Efficacy Trial
- Evidence on breakthrough infection and immunity (2) - Correlates of Protection
- Evidence on breakthrough infection and immunity (3) - Sputnik V (Gam-COVID-Vac)
- Assays for SARS-CoV-2: Calibration of the Duke and Monogram Pseudovirus
- Overview of studies reporting on immunological end points
- Understanding T cell immunity to COVID-19 and relationships to vaccine correlates and mechanisms of protection
Updates from vaccine developers:
- Flinders University
- Geno-Immune Medical Institute
- Medigen
- Nanogenpharma
- Cellid
- Janssen
- Providence Therapeutics
- Vaccine and Infectious Disease Organization (VIDO)
- City of Hope Medical Center
Session
2: CURRENT PROPOSALS FOR REVIEW AND SYNTHESIS OF THE EVIDENCE
- Analysis and Synthesis (1) - Predicting vaccine protection from SARS-CoV-2 variants
- Analysis and Synthesis (2) -Defining a CoP
- Analysis and Synthesis (3) - Initiatives to Analyze and Synthesize Available Data
- Augmenting information about CoP (1) - Reliably Establishing ‘Correlates of Protection’─ What Evidence is Needed?
- Augmenting information about CoP (2) - Potential of large-scale, simple randomized trials for augmenting information about correlates of protection and reliably establishing correlates of protection
- Does emerging data allow increased reliance on vaccine immune responses for regulatory decision-making?
- Conclusions and next steps