2022-08-21-世界卫生组织-2022_ACSoMP_recommendations_4页_209kb

Summary of the First Joint Meeting of WHO GACVS and ACSOMP (14–16 June 2022)

Core Content

The first joint meeting of the WHO Global Advisory Committee on Vaccine Safety (GACVS) and the WHO Advisory Committee on Safety of Medicinal Products (ACSOMP) was held virtually from 14 to 16 June 2022. This meeting aimed to integrate pharmacovigilance efforts for both medicines and vaccines, and to address key safety concerns related to specific drugs and their use in vulnerable populations, such as pregnant women and children.

Main Objectives and Focus Areas

• Integration of Pharmacovigilance: The establishment of an integrated WHO Pharmacovigilance team in 2020 enabled the joint meeting, focusing on shared safety concerns.
• Valproate Usage in LMICs: A survey was planned to assess valproate usage and risk minimization measures in low- and middle-income countries (LMICs), building on prior work in India.
• Miltefosine and Eye Disorders: A review of reported ocular disorders following miltefosine treatment in India was conducted, with recommendations for further studies and safety monitoring.
• Safety of COVID-19 Therapeutics and Vaccines: Updates on WHO recommendations for therapeutics and the safety monitoring of vaccines during pregnancy were shared.
• WHO Listed Authorities (WLAs): A new framework for evaluating and listing regulatory authorities was introduced, replacing the concept of stringent regulatory authorities (SRAs).

Key Recommendations

1. Valproate Survey Design

• Include interviews alongside surveys to enhance response rates and data depth.
• Stratify data by responder specialty to identify potential biases.
• Collect information on alternative treatments and barriers to their use (e.g., cost, access).
• Follow-up children exposed to valproate in utero to assess long-term effects.
• Use pregnancy or disease-specific registries to monitor outcomes over time.
• Include paediatricians in awareness campaigns to address long-term risks for adolescent and adult patients.

2. Miltefosine Safety Monitoring

• Comment on ToR for the multistakeholder expert group assessing causality and risk minimization.
• Consider all available evidence, including safety data from similar therapeutic products.
• Calculate number needed to harm and number needed to treat for benefit-risk assessments.
• Ensure awareness of recommendations in all countries using miltefosine.
• Share SOPs for pre-treatment ophthalmic examination and ongoing monitoring.
• Conduct a multi-country pharmacovigilance study to improve data collection and awareness.
• Support pharmacogenomic/molecular studies to provide rapid insights.

3. Safety Monitoring for COVID-19 Therapeutics and Vaccines

• Molnupiravir requires active pharmacovigilance, including cohort event monitoring (CEM) studies in LMICs.
• Develop standardized case report forms (CRFs) to capture gestational age and concomitant medications.
• Address data privacy laws across countries to ensure compliance and ethical data sharing.

4. Pregnancy Safety Monitoring Initiatives

• Three ongoing initiatives:
  • Pregnancy Exposure Registries: Mapping and assessment of registries in LMICs.
  • Data Harmonization: Standardizing data elements for maternal and neonatal outcomes.
  • WHO COVID-19 Pregnancy Cohort Study: A longitudinal study tracking 21,000 pregnant women.
• Expert Steering Committee (ESC): Provides scientific guidance on pregnancy safety monitoring.
• Standardized training and CRFs: Ensure consistency in data collection across countries.

5. WHO Listed Authorities (WLAs) Framework

• Replaced the concept of SRAs based on changes to ICH in 2015.
• WLAs are regulatory authorities or systems that meet WHO’s benchmarking and performance evaluation criteria.
• PEF (Performance Evaluation Framework): Includes seven indicators assessed during field trips.
• GBT (Global Benchmarking Tool): Used as a basis for evaluation.
• Pilot phase: Ongoing in 2–4 countries, with updates planned for the PEF manual and WLA guidance by the end of 2022.
• Promote reliance on WLAs to improve regulatory cooperation and access to quality medicines and vaccines.

Conclusions

The joint meeting emphasized the importance of robust pharmacovigilance systems for both medicines and vaccines, particularly in LMICs. It highlighted the need for data harmonization, risk minimization strategies, and ethical data handling. The initiatives on valproate, miltefosine, and pregnancy safety monitoring aim to improve public health outcomes and regulatory capacity. The WLA framework supports global regulatory collaboration and enhances access to safe and effective health products.