Development

We partner with qualified vaccine manufacturers (usually from developing countries) to develop vaccines. The partnership varies depending on the manufacturer but we provide technology transfer, and technical and financial support for process development and scale-up to clinical development to registration and WHO prequalification.

Our partnerships are based on a common goal of making vaccines available for global public health.  At the heart of the product development partnerships is a commitment by the manufacturer to produce vaccines at high-quality standards and to provide them in sufficient quantities to the public sector at an affordable price.

Process Development and Technology Transfer

Qualified manufacturing partners are identified through a selection process. Technology transfer is conditional upon the manufacturer producing vaccines at high-quality standards at a low-cost in a country with a WHO-approved National Regulatory Authority (NRA.

To keep production costs down, IVI works to maximize the yield of vaccine antigens and to optimize purification of antigens.  By keeping manufacturing costs down, we make vaccines more affordable for developing countries and increase the probability of success in technology transfer of the vaccines.  We also conduct quality control assays to ensure the process is controlled and consistent from batch to batch and the final product meets a pre-specified quality standard.

Tech transfer partner Status
VaBiotech, Vietnam Bivalent killed whole-cell oral cholera vaccine
Partnered with VaBiotech on modifying the vaccine and tech-transferred quality control assays and reagents; vaccine currently licensed and used in Vietnam as mORC-VAX.
Shantha Biotechnics, India Bivalent killed whole-cell oral cholera vaccine
Partnered with Shantha on clinical development, licensure in India, and WHO prequalification; Shanchol™ WHO-prequalified in 2011 and currently used in the WHO stockpile.
EuBiologics, South Korea Bivalent killed whole-cell oral cholera vaccine
Currently working with EuBiologics on late-stage clinical development; Euvichol expected to be WHO- prequalified in 2016.
SK Chemicals, South Korea Typhoid conjugate vaccine (Vi -DT)
Currently working with SK Chemicals on clinical development; vaccine expected to be WHO-prequalified by 2020.
PT BioFarma, Indonesia Typhoid conjugate vaccine (Vi-DT)
Currently working with BioFarma on clinical development; vaccine expected to be WHO-prequalified by 2019.
Incepta Vaccine Ltd., Bangladesh Bivalent killed whole-cell oral cholera vaccine
Typhoid conjugate vaccine (Vi- DT)Currently working with Incepta on clinical development and licensure of the two vaccines for the domestic market.

Clinical Development

To assess vaccine safety and efficacy in humans, we work with partners to plan and implement clinical trials (phase I to III, as well as phase IV).  We provide training, technical assistance and financial support, as well as help coordinate and monitor trials to ensure international standards and principles of good clinical practice are met.

Regulatory Review and Approval

We work with manufacturers or sponsors of the new vaccine product in the regulatory approval process by helping them navigate the regulatory pathway and providing support on the various steps involved from preparation of the Investigational New Drug application to inspection of the manufacturing facility.  More specifically, we support manufacturers on getting their vaccine product approved under , which ensures that drugs and vaccines bought by countries and international procurement agencies (e.g., UNICEF) meet acceptable standards of quality, safety and efficacy.

Vaccine Safety

We also work to ensure vaccine safety by helping health authorities collect and analyze information from reports of adverse events that occur after administration of licensed vaccines.  In collaboration with , we developed a software tool for collecting and processing information on adverse events following immunization (AEFI). The Vaccine Adverse Events Information Management System (VAEIMS) was recently pilot-tested in Sri Lanka and evaluated for its ability to transfer AEFI data from health outposts into a central database for processing and conversion of raw data to information for action.