Enhancing Vaccine Regulation for Pandemic Preparedness

Building regional regulatory capabilities in Asia and the Pacific requires strong oversight and sustained commitment to strengthening vaccine regulatory systems.

Introduction

Globally, vaccine manufacturing is highly geographically concentrated. Beyond major vaccine producers such as the People’s Republic of China, India, Japan, and Indonesia, vaccine manufacturing is mainly clustered outside of Asia and the Pacific. With Asia and the Pacific home to over 60% of the world’s population, vaccine production is severely inadequate to meet the needs of the region.

Before the COVID-19 pandemic, the regulatory lag time for vaccines in Asia and the Pacific—the time between the first global approval date and its approval in other countries—was as long as 52 months.

Although regulatory responses such as the emergency use listing of the World Health Organization (WHO) and rolling reviews have significantly facilitated access to vaccines worldwide during the COVID-19 pandemic, it remains uncertain if this is sustainable.

Post-pandemic discussions surrounding the regionalization of vaccine production in Asia and the Pacific are gaining traction. However, its successful implementation requires strong regulatory oversight of vaccines produced and sustained commitment to strengthening regulatory systems.

This article is the first installment of the "vaccine manufacturing and regulatory systems strengthening" series.