Global vaccine safety network to launch in six countries across three continents

• New US$5.5M initiative will generate critical safety data for new vaccines in low- and middle-income countries
• Partnership with DCVMN and INCLEN supports CEPI’s 100 Days Mission and pandemic readiness
• Data will be openly shared to strengthen global public health responses

29 October, Oslo. A pioneering new vaccine safety surveillance network was unveiled today to coincide with the Developing Countries Vaccine Manufacturers Network (DCVMN) Annual General Meeting, in Bali, Indonesia. The network—called the International Network for Vaccine Safety Surveillance (INNOVATE)—will be launched across nine sites in six countries including Brazil, Ethiopia, India, Indonesia, Kenya and South Africa. CEPI will invest up to US$5.51 million over three years to support the development of this platform, which is being established by the India-based International Clinical Epidemiology Network Trust International (INCLEN) and Geneva-based DCMVN.

The initiative will help researchers understand the rates of naturally occurring clinical events such as Guillain-Barré Syndrome, thrombosis with thrombocytopenia syndrome, and anaphylaxis. Establishing these background rates is essential for detecting early safety signals that might be associated with immunisation and for managing risks when new vaccines are introduced.

Building a global safety net for vaccines

The INNOVATE platform will serve as a ready-to-deploy surveillance network for CEPI-supported vaccine developers, enabling rapid pharmacovigilance activities during outbreaks. It will help vaccine manufacturers and public health authorities respond faster and more effectively during outbreaks. By having surveillance networks already in place, countries can avoid delays in monitoring vaccine safety during emergencies. The platform also supports CEPI’s 100 Days Mission, which aims to develop safe and effective vaccines within 100 days of a future pandemic threat being identified.

The project will also complement CEPI’s wider investments in vaccine safety, including similar efforts to establish background rates of adverse events specific to African populations and research to understand the biological factors that might predict adverse events of special interest potentially related to vaccination. 

The network is designed to be able to work with existing databases in low-income and middle-income countries and to be scalable for potential integration into future global surveillance structures. Data generated by the INNOVATE project will also be used to train CEPI’s Pandemic Preparedness Engine, an AI assistant for vaccine developers, serving as a virtual scientific collaborator capable of helping researchers identify and synthesise vast swathes of information, test hypotheses and advance vaccine development at unprecedented speed.

Equitable access is central to the partnership. CEPI, DCVMN and INCLEN have committed to ensuring that all outputs from the project are accessible to the global community, including regulators, developers and manufacturers around the world.

Dr Richard Hatchett, CEO of CEPI, said: “Establishing this international vaccine safety surveillance network will provide vital context for interpreting vaccine safety signals in clinical trials and public health responses. By generating region-specific data on expected adverse events, we can help regulators and manufacturers make faster, more informed decisions—ultimately accelerating access to safe, effective vaccines during emergencies.”

Mr Rajinder Suri, CEO of DCVMN, said: “The INNOVATE project is a first of its kind and will establish an Active Vaccine Surveillance System (AVSS) for half a million people in six low and middle income countries, representing a wider population of 2 billion people. I’m convinced this will pave the pathways for rapid vaccine approvals more broadly in low and middle-income countries.”

Prof Narendra Kumar Arora, Executive Director of INCLEN, said: “INNOVATE will generate a critical evidence base on the background rates of serious and severe clinical events and signals, in low- and middle-income countries, which may occasionally be associated with vaccination across the age spectrum. The findings shall help regulators, vaccine manufacturers, researchers and policy makers to make well-grounded and quicker decisions on the use of safe and effective vaccines during emergencies and also maintain community trust. The success of this vaccine safety surveillance network is poised to be an exemplar for other low- and middle-income countries”. 

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About CEPI 

CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to accelerate the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

About DCVMN

Developing Countries Vaccine Manufacturers Network International (DCVMN) is a global alliance of over 45 manufacturers from 17 LMICs, collectively supplying more than 60% of the vaccines procured globally and reaching over 170 countries worldwide. Our mission is to strengthen the capacity of vaccine producers in the Global South through policy advocacy, technical training and access to innovation to ensure timely, affordable, and equitable access to vaccines and driving sustainable solutions to meet current and future public health needs.

About INCLEN

INCLEN is a research institution in public health sciences that undertakes multidisciplinary collaborative policy, program and practice relevant research through the network of institutions that are responsive to the national, regional and global priorities.