2025-05-08-世界卫生组织-2024_November_ACSoMP_recommendations_7页_237kb

Summary of the Fourth Joint Meeting of WHO ACSoMP and GACVS (12-14 November 2024)

Core Content

The fourth joint meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSoMP) and the WHO Global Advisory Committee on Vaccine Safety (GACVS) took place from 12 to 14 November 2024. The meeting addressed key safety issues related to vaccines, medicines, and pharmacovigilance, with a focus on pediatric populations, pregnant women, and specific therapeutic areas.

Main Topics and Recommendations

1. Safety of Arpraziquantel (arPZQ) for Schistosomiasis in Children

• Background: arPZQ, a dispersible tablet formulation, was approved by the EMA in December 2023 and included in WHO's Prequalified Medicines list in May 2024.
• Rollout: The UNDP-led Access and Delivery Partnership (ADP) is supporting the rollout in Ghana, Senegal, and Tanzania, with pilot programs planned for 2025.
• Safety Profile: Merck's data shows a favorable safety profile in children aged 3 months to 6 years, similar to PZQ.
• Challenges: Limited safety data for children under one year of age; active surveillance is needed.
• Recommendations:
  • Engage all relevant stakeholders in developing pharmacovigilance workplans.
  • Avoid parallel systems and use existing ones.
  • Encourage WHO to develop tools like a guidebook for LMICs.
  • Explore the use of Smart Surveillance Strategy for arPZQ.

2. Safety of RSV Monoclonal Antibody, Nivsevimab

• Overview: Nivsevimab is a long-acting monoclonal antibody targeting the RSV F protein, approved in over 40 countries.
• Safety Data: No serious adverse events were reported in clinical trials; no safety concerns with coadministration with vaccines.
• Adverse Events: Common include drug ineffectiveness, RSV bronchiolitis, and medication errors.
• Recommendations:
  • Continue monitoring for frequent and rare adverse events.
  • Investigate safety in coadministration with vaccines in mothers and children.
  • Monitor hypersensitivity reactions in older children.
  • Explore safety in sequence with other vaccines.

3. Safety of Malaria Medicines in Pregnancy

• Recommendation Update: WHO now recommends artemether-lumefantrine (AL) for uncomplicated malaria in the first trimester, replacing quinine and clindamycin due to new safety evidence.
• SAFIRE Trial: A phase IIIb trial is assessing safety and efficacy of AL, PA, and DP in the first trimester across Mali, Burkina Faso, and Kenya.
• G6PD Testing: WHO updated guidelines on G6PD testing for tafenoquine and primaquine to prevent hemolytic anemia.
• Recommendations:
  • Continue monitoring pregnancy outcomes for CAB-LA, LEN, and DPV.
  • Support the Pregnancy Therapeutic Working Group to harmonize data and update guidelines.
  • Expand the toolkit for ARV research in pregnancy and prioritize syphilis-related studies.

4. Update on Valproate Usage in Women of Childbearing Potential

• Issue: Valproate is a known teratogen but still used in pregnant women in LMICs due to lack of safer alternatives.
• WHO Actions: Updated guidelines to discourage use in WOCBP; supported studies on usage patterns and risk factors in SEARO.
• Recommendations:
  • Expand risk minimization efforts to other regions.
  • Include other anti-seizure medicines in the study.
  • Assess reasons for continued use, including cost and availability.
  • Evaluate knowledge of risks among prescribers and users.
  • Incorporate qualitative methods and address ethical concerns.

5. Safety of Tecovirimat for Treatment of Mpx

• Usage: Tecovirimat is used for smallpox, mpox, and cowpox, indicated for adults and children ≥13 kg.
• Safety: EMA reported mild adverse effects, but data on use in pregnancy, breastfeeding, and immunocompromised patients is limited.
• Recommendations:
  • Share new data from the post-authorization safety study (expected final report in 2026).
  • Engage pharmacovigilance stakeholders in future programs.
  • Tailor PV and risk minimization strategies to the region of use, especially for psychiatric side effects.

6. Safety of Fexinidazole for Human African Trypanosomiasis (HAT)

• Overview: Fexinidazole is the first oral treatment for HAT, approved by EMA in 2018 and extended to T. rhodesiense in 2023.
• Safety Concerns: Common side effects include vomiting, psychiatric issues (e.g., depression, anxiety), and others.
• Current Study: A phase 3 post-authorization safety study is ongoing with WHO and Sanofi, showing alignment with clinical trials.
• Recommendations:
  • Share new data from the study with the Committee.
  • Ensure education, training, and surveillance on psychiatric adverse effects.
  • Address data collection challenges in culturally diverse settings.

Key Information

• The meeting emphasized collaboration among stakeholders for effective pharmacovigilance.
• Special attention was given to safety in vulnerable populations such as children and pregnant women.
• The importance of data harmonization and the use of existing systems was highlighted.
• WHO is actively working on updating guidelines and supporting research in LMICs.