India Rejects Chinese Polio Strain in 6-in-1 Vaccine

“Unlike the Salk IPV, which is derived from a wild virus, the Sabin version uses an attenuated form of the virus that is then inactivated, making it much safer from a containment perspective. Furthermore, these are not 'Chinese strains' in a proprietary sense. These strains are distributed and routed through the WHO and the Netherlands Institute. In fact, the Sabin IPV manufactured by Sinovac is already a WHO pre-qualified vaccine.”

“Ultimately, bringing more players into this space is essential for cost-competitiveness. Our programme is designed to support both the private market with single-dose vials and the government’s Universal Immunization Programme with multi-dose formats, should they choose to transition to hexavalent protocols.”

“The proposal to use the Sabin strain, the same strain used in the oral polio vaccine (OPV), presents a unique challenge. If there is an accidental lab leak during trials and the virus revives, it would become hard to preserve India's polio-free status. Conducting such trials is simply not possible without robust, WHO-certified facilities to manage the storage and handling of the materials.”

“What happened post-marketing? That data is only from Pakistan and China; that is not enough; so, we cannot risk that. India is not currently facing a shortage that would justify taking such a risk. We have enough supply of the traditional IPV now. That was an issue a few years back, but now supply is not an issue.”

“The SEC outcome signals India’s regulator is aligning with WHO’s Global Action Plan, making poliovirus facility certification non-negotiable. Manufacturers must demonstrate robust alignment with containment frameworks, proactively engage with National Authorities for Containment, and share broad international safety data to satisfy evolving global expectations on vaccine quality and biosafety.”

“Poliovirus Containment Certification is a non-negotiable strategic biosecurity imperative. Safeguarding India’s hard-won polio-free status requires absolute assurance that no poliovirus can escape manufacturing facilities. This certification, per WHO’s GAP-III, provides that assurance through stringent oversight, reinforcing confidence in our vaccine ecosystem.”

“Any additional strain of polio in the six-in-one vaccines must be compliant with all guidelines and regulations. The strain must have clinical real-world data validation of phased trials, which document the threshold of vaccine effectiveness. If the Chinese data is missing, then it’s best not to use that vaccine. The worst thing is to bring in a neurotropic unverifiable strain on Indian shores.”