New WHO International Reference Reagents established to improve polio vaccine testing and quality control
PATH applauds recent news that the World Health Organization Expert Committee on Biological Standardization (WHO ECBS) has recommended the establishment of new International Reference Reagents for polio vaccine testing using next-generation high-throughput sequencing (NGS) technology. The announcement marks an important milestone toward harmonizing and strengthening polio vaccine quality control as part of global polio eradication efforts.
The new International Reference Reagents will enable vaccine manufacturers and researchers around the world to standardize the use of NGS for testing oral polio vaccines (OPVs) for poliovirus types 1 and 3. The NGS assay is a highly sensitive testing method that allows researchers to quickly map the population of poliovirus genomes to monitor the consistency of vaccine production. It is an alternate non-animal-based method to assess neurovirulence markers of vaccine lots.
The establishment of the NGS technology as applied to live oral polio vaccine manufacturing lots testing is an outcome of a WHO collaborative study led by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in collaboration with PATH and other partners.
“We are very pleased that the WHO ECBS has endorsed these new high-throughput sequencing reference reagents for oral polio vaccines,” says Dr. Javier Martin, Head of the WHO Polio Global Specialized Laboratory at MHRA. “The WHO Collaborating Centre for Reference and Research on Poliomyelitis at MHRA has worked for many years to develop and standardize molecular approaches that strengthen polio vaccine quality control. Coordinated by Dr. Manasi Majumdar, this recent work is an important step toward establishing next-generation high-throughput sequencing as a robust quality-control assay for polio vaccines and supporting the transition to a more precise, reproducible, and sustainable molecular methods for testing neurovirulence markers that are non-animal-based. These reagents will help provide detailed molecular insight into vaccine production and support global confidence in the quality, safety and consistency of polio vaccines.”
“PATH welcomes these new International Reference Reagents endorsed by WHO and is proud to have been a technical assistance partner in developing the NGS technology and bringing partners together,” says Dr. Kutub Mahmood, director of PATH’s polio assay standardization projects. “By improving the ability to test polio vaccines with greater sensitivity via sustainable methods, the availability of reference reagents is an important advancement in the global effort to continually strengthen and harmonize the NGS assay for use in polio vaccine production.”