New Delhi: The Subject Expert Committee (SEC) on Vaccines, under the Central Drugs Standard Control Organisation (CDSCO), has directed Zydus Lifesciences to revise and resubmit its Phase I clinical trial protocol for the company's inactivated chikungunya vaccine candidate, citing gaps in preclinical and immunogenicity data.

This came after Zydus Lifesciences presented the Phase I/II clinical trial protocol of the study titled "A prospective, randomized, double-blind, placebo-controlled, phase I/II clinical trial to evaluate the safety and immunogenicity of the Chikungunya vaccine candidate of M/s. Zydus Lifesciences Ltd. in healthy participants." Also Read: Bharat Biotech Gets SEC Nod to Begin Phase III Trial of Inactivated Chikungunya Vaccine

The committee noted the following points:

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