2024-10-15-世界卫生组织-WHO_Target_Product_Profiles_for_mpox_Vaccines_4页_446kb

报告摘要

Document Purpose

This version 1 of the WHO Target Product Profiles (TPP) for mpox vaccines outlines current priorities for vaccine development based on available data. It is intended for WHO research priorities, product development, and aims to guide stakeholders in creating vaccines. Key requirements include adherence to WHO guidelines for emergency use listing (EUL) and prequalification. If a vaccine's profile exceeds critical characteristics in one or more categories, it may outweigh deficiencies elsewhere.

Background

The WHO declared the mpox situation, including ongoing outbreaks in the Democratic Republic of the Congo and other regions, a Public Health Emergency of International Concern (PHEIC) and International Health Regulations. Globally, there have been 99,176 confirmed cases and 208 deaths. The virus involves multiple clades, with Clade II MPXV circulating in West Africa and Clade I in specific regions like the DRC. Currently, some vaccines are approved in certain countries, but global supply is limited, particularly for low- and middle-income countries.

Key Requirements for Mpox Vaccines

The TPP defines preferred and minimum acceptable characteristics for mpox vaccines:

Indication: Prevention of mpox disease and reduction of severe cases or transmission, with minor contraindications limited to hypersensitivity or specific conditions.
Target Population: All ages (adults, children, infants); data must support use in special groups like pregnant or immunocompromised individuals.
Safety and Reactogenicity: Minimal reactogenicity and no serious adverse events; point estimates of efficacy >90% for unknown virus immunity in naive populations.
Effectiveness: Efficacy against relevant monkeypox clades; support from animal studies, immune response data, and preferably randomized clinical trials.
Dose Regimen: Single dose or up to two primary doses; boosters permissible; protection durability at least ≥3 years preferred, or ≥6 months minimum.
Deployability: No need for specialized equipment; shelf life ≥2 years at ambient temperature; ability to be administered with antivirals; compatibility with other vaccines.
Registration: Requires WHO prequalification or EUL, ensuring adequate supply and registration for public health emergencies, with affordability and accessibility for developing countries.