Advancing vaccines justice through international regulatory pathways

Area of Science:

• Global Health Policy
• Vaccine Regulation
• International Law

Background:

• Equitable global access to vaccines is crucial for public health but hindered by resource-intensive regulatory processes.
• Timely regulatory approval is a key determinant of vaccine justice, yet often faces significant delays, especially in low- and middle-income countries (LMICs).
• Existing international pharmaceutical regulatory policies often overlook the needs of historically marginalized LMICs.

Purpose of the Study:

• To critically examine vaccine regulatory policies through the lens of 'Third World Approaches to International Law' (TWIL).
• To challenge dominant narratives in international pharmaceutical regulation by centering the perspectives of LMICs.
• To illustrate how modern regulatory reliance trends align with 'third world approaches' to vaccine justice.

Main Methods:

• A critical analysis of current international regulatory reliance trends, including South-South reliance and reliance on European Medicines Agency (EMA) opinions for global health products.
• Application of a 'Third World Approaches to International Law' (TWIL) framework to evaluate vaccine regulatory policies.
• Examination of how these trends impact vaccine justice and access for historically marginalized LMICs.

Main Results:

• Modern trends in regulatory reliance, specifically South-South cooperation and EMA reliance for global health, are increasingly adopting 'third world approaches' to vaccine justice.
• These reliance mechanisms demonstrate a potential to embrace principles that challenge dominant international regulatory norms.
• Strengthening international regulatory pathways can help overcome approval bottlenecks for vaccines already deemed safe and effective.

Conclusions:

• Regulatory reliance, particularly South-South and EMA-based models for global health, offers a promising pathway to accelerate vaccine approval and enhance global vaccine justice.
• These approaches can help alleviate regulatory bottlenecks, streamlining registration processes and improving access to essential vaccines, especially during health emergencies.
• Capacity building through international regulatory cooperation is vital for achieving equitable global vaccine access.