Member State Representatives,
Partners and colleagues,
Good morning.
Let me begin by thanking the Government of India for hosting this workshop and for its continued leadership as one of the world’s most important contributors to vaccine manufacturing and global immunization.
I would also like to thank CEPI for co-hosting this meeting, for its leadership in advancing the 100 Days Mission, and congratulate the partnership on the launch of its CEPI 3.0 strategy, which continues to drive global ambition in pandemic preparedness.
Our region is home to one of the largest concentrations of vaccine manufacturing capacity in the world, supplying a substantial share of vaccines used in routine immunization globally.
But the region is no longer only manufacturing vaccines.
Across South-East Asia, research capacity, clinical trial networks, and regulatory systems are strengthening.
In other words, our region is not simply a beneficiary of global vaccine equity — we are a key contributor to it.
And because of that, the choices we make about preparedness will shape the global response to the next pandemic.
This brings me to three points I would like to leave with you today.
My first point is this:
Manufacturing strength must be matched by regulatory readiness.
The COVID-19 pandemic showed what is possible when science, financing, manufacturing, and regulation align.
But it also showed that manufacturing scale alone does not guarantee timely access.
Regulatory agility, cross-border coordination, and trusted evidence pathways are equally essential.
This becomes even more important when we think about CEPI’s 100 Days Mission — the goal of developing a safe and effective vaccine within 100 days of identifying a pandemic threat.
Emerging pathogens are unpredictable. Outbreaks may be sporadic or decline before Phase III trials can be completed. In some situations, randomized trials may be ethically or logistically impossible.
If regulatory pathways depend solely on large efficacy trials, we risk losing valuable time.
That is why regulatory innovation is central to this discussion.
We must align around alternative evidence pathways that remain scientifically robust and internationally credible, including immunobridging, validated correlates of protection, well-characterized animal models, platform-based authorizations, adaptive trial designs, and the use of real-world evidence.
But these approaches will only work if regulators agree on them in advance.
Alignment on surrogate endpoints, evidence thresholds, and post-authorization data requirements must happen before the next emergency.
My second point is this:
Speed in a pandemic depends on coordination across the entire vaccine ecosystem.
Pandemic response is not just about science or manufacturing.
Speed depends on the entire ecosystem working together — from discovery and research, to clinical trials, manufacturing, regulatory authorization, procurement, and deployment.
Our region already has many of these capabilities.
We have expanding platform technology hubs, including mRNA and viral vectors.
We have established clinical trial capacity from Phase I to Phase III.
We have strong manufacturing bases and growing diversification into new technologies.
But integration across borders remains limited.
To move faster during the next emergency, we must strengthen regional operational coordination.
This includes harmonized clinical trial networks with pre-approved master protocols, surge-ready manufacturing models, shared logistics platforms, and interoperable regulatory systems.
My third point is this:
Regional regulatory reliance can dramatically accelerate access.
Reliance mechanisms allow authorities to leverage trusted regulatory assessments, reduce duplication, and accelerate decision-making — without compromising rigor.
Importantly, the foundations for this collaboration already exist in our region, including through the South-East Asia Regulatory Network, SEARN.
The next step is to institutionalize this collaboration through routine joint reviews, shared inspections, common technical dossiers, and alignment on evidence standards.
And this work must happen before the next crisis.
Preparedness cannot be episodic. It must be sustained between emergencies.
Manufacturing sustainability requires predictable demand, regional market shaping, diversified product portfolios, and long-term technology transfer partnerships.
Regulatory excellence requires continued investment in regulatory science, digital transformation, and maturity strengthening.
And research preparedness requires standing clinical trial networks and continuous pathogen surveillance.
As WHO, we stand ready to support Member States and partners.
We will continue strengthening regulatory systems through benchmarking, capacity-building, and support for reliance frameworks.
We will continue to convene regulators, manufacturers, and clinical trial networks across the region.
And we will continue to provide normative guidance on emergency use pathways, immunobridging strategies, and vaccine platform evaluation.
We will also work closely with partners including CEPI, Gavi, UNICEF, ADB, and the World Bank to ensure that investments across research, manufacturing, and regulatory systems reinforce one another.
South-East Asia has the population scale, manufacturing strength, scientific talent, and growing regulatory capability to become a global leader in pandemic vaccine response.
Our opportunity now is to transform capacity into coordinated capability.
If we succeed, when the next pathogen emerges, vaccines will be:
developed rapidly,
authorized efficiently,
manufactured sustainably,
and deployed equitably.
And that is ultimately what pandemic preparedness means:
not only the ability to develop vaccines quickly —
but the ability to ensure that every country can access them when they are needed most.
Let us use this workshop to move forward together — toward alignment, implementation, and action.
Thank you.