2022-09-12-世界卫生组织-Prioritization_of_candidate_vaccines_for_international_support_for_further_evaluation_including_Phase_IIb_3_randomized_clinical_trials_6页_290kb

Solidarity Trial: COVID-19 Vaccine Prioritization Overview

Context

• Emergence of SARS-CoV-2 in December 2019 and rapid global spread declared a PHEIC and Pandemic by WHO.
• Pressure for effective vaccines increases.
• Over 160 candidate vaccines in development, more than 21 in clinical trials.
• We Need a standardized, transparent process to prioritize vaccines for limited resources.

Objectives

• Establish an independent expert working group.
• Review all COVID and other pathogen candidate vaccines against pre-defined attributes and criteria.
• Score and recommend prioritization for international support and Phase IIb/III trials.
• Conduct monthly continuous reviews of emerging evidence.
• Advise WHO, promoting consistent and predictable evaluation to encourage investment.

Process

1. Data Request: Invite developers to provide info using pre-defined format.
2. Evidence Review: Experts individually review data, score using a scoring guide to ensure consistency.
3. Decision Making: Consensus reached by quorum (at least 2/3 participating). Summaries announced, not detailed info. Monthly updates mandated.

Composition

• Fixed Members:
  • Chair: Myron M. Levine, MD (CVM & Global Health, Univ. of Maryland).
  • Rapporteur: Elizabeth Miller, OBE, PhD (ID Epidemiology, London School of Hygiene & Tropical Medicine).
  • World Health experts: Dr. Rebecca E. Chandler (Uppsala Monitoring Centre), Dr. Sudhanshu Vrati (Regulatory dB), Dr. Junzhi Wang (NIFDC), Dr. Sue-Nie Park (Korea Univ.), Dr. Sergio de Andrade Nishioka (Fiocruz), Dr. Subhash Kapre (InventVax), Prof Dani Cohen (TLV School of Public Health), Dr Collins Tabu (Kenya EPI).
• Former Member: Prof Gavin Churchyard.
• Observers: Prof César Muñoz-Fontela, Dr Simon Funnell.

Scope

• Covers various expertise: expertise in COVID vaccines, animal models, clinical evaluation, regulation, manufacturing (GMP), epidemiology, vaccinology, service delivery, ethics, social anthropology, vaccine safety.