Regulator nixes Indian Immunologicals plan for 6-in-1 vaccine over China polio strain

Subscribe to enjoy similar stories. New Delhi: India’s drug regulator has signalled zero-tolerance for polio-related risk, turning down a proposal by National Dairy Development Board's (NDDB) subsidiary Indian Immunologicals Ltd (IIL) to start human trials of its ‘six-in-one’ paediatric vaccine over concerns it could undermine the country’s polio-free status, according to two government officials and documents reviewed by Mint.

The Central Drugs Standard Control Organisation’s (CDSCO) decision, linked to the use of the China-sourced poliovirus antigens highlights how public-health security and biosafety considerations matter the most, even as vaccine makers push to introduce next-generation combination shots in a market immunizing tens of millions of children each year. While the hexavalent vaccine is not used under the government’s universal immunization programme as of now, it is available in the private sector, wherein a parent can choose to pay for hexavalent vaccines.

A regulatory clearance for IIL and the following set of approvals would have paved the way for the vaccine’s commercial launch in India. According to government documents, the primary cause for the rejection is the company's use of Chinese firm Sinovac's antigens that have never been used in any approved polio vaccines—oral or injectable—in India.

While 10.01 million doses of this specific Sabin Inactivated Poliovirus Vaccine (sIPV) have been distributed globally; the usage has been restricted to China, Thailand and Pakistan. The decision follows a high-level review by the subject expert committee (SEC) for vaccines, which raised an alarm over the safety and containment of the Chinese polio strain.