2022-02-28-世界卫生组织-WHO_Advisory_Committee_on_Safety_of_Medicinal_Products_COVID-19_Therapeutics_Sub-Committee_3页_48kb

WHO Advisory Committee on Safety of Medicines' COVID-19 Sub-Committee Summary

Background

The committee was established in early 2022 to address the safety monitoring of COVID-19 therapeutic products. It focuses on evaluating emerging evidence from emergency authorizations to detect and manage potential safety issues, ensuring public confidence during the pandemic.

Mission

To review, evaluate, and interpret post-introduction safety data for COVID-19 medicines, providing WHO with advice on overall safety, additional monitoring needs, and public communication strategies.

Objectives

The sub-committee aims to:

1. Advise WHO on the safety profiles of COVID-19 treatments.
2. Recommend post-introduction studies to investigate safety signals and risk minimization activities.
3. Guide the development of safety advisories, alerts, and risk communication materials for WHO and Member States.

Scope of Review

The scope includes:

• Analyzing safety reports (published/unpublished), special population data (e.g., pregnant women, children), and manufacturer communications.
• Reviewing data from ongoing and completed clinical/observational studies.
• Assessing needs for additional studies when safety signals arise.

Expected Outcomes

It produces:

• Draft recommendations on safety, risk management, and communications.
• These inform WHO decisions, including the benefit-risk profile for WHO Prequalification listings and national COVID-19 treatment policies.

Duration and Management

Minimum 6-month duration, led by co-chairs; supported by a scientific rapporteur compiling data summaries; meetings held virtually monthly; oversight by WHO PVG team and secretariat.