Regulatory Roadblock for Zydus: CDSCO Panel Halts MMRV Vaccine Trial, Seeks Adult Data
New Delhi: Zydus Lifesciences Limited's plan to conduct a Phase II/III clinical trial of its Measles, Mumps, Rubella and Varicella (MMRV) vaccine has hit a roadblock, with the Subject Expert Committee (SEC) on Vaccines under the Central Drugs Standard Control Organisation (CDSCO) directing the company to first submit a Phase I protocol in healthy adults for the new formulation before moving forward.
According to the minutes of the SEC meeting held on July 25, 2025, the firm presented a Phase II/III protocol titled:
“A prospective, randomized, parallel, single-blind, two arm, active-controlled, multicentre, phase II/III clinical trial to evaluate the immunogenicity and safety of Measles, Mumps, Rubella and Varicella vaccine of M/s. Zydus Lifesciences Ltd. compared with Measles, Mumps, Rubella and Varicella vaccine of M/s. GlaxoSmithKline Biologicals in healthy children aged 15–18 months.”
The committee noted that “Phase I clinical trial permission was granted in 2015 and the clinical study report is submitted recently in 2025 and also the firm has proposed new formulation of Varicella Vaccine in the applied product.”
In light of this, the SEC opined that the applicant is required to clarify the following points:
“Justification for the delay in the submission of Phase I study report.”
“Differences in the vaccine formulation used in Phase I and proposed in Phase II/III protocol with respect to inactive ingredients & manufacturing process and justification for consideration of the Phase I report for conduct of Phase II / III study.”
“Justification for proposing Phase II/III clinical trial in the age group 15–18 months with new formulation and not proposing a Phase I protocol in healthy adult population with new formulation.”
“Justification for the limited sample size in Phase II/III study with new formulation.”
“Non-inferiority is not incorporated as primary objective in currently proposed Phase II/III clinical trial protocol.”
After detailed deliberation, the committee recommended that the firm should submit adequate response with justification along with Phase I clinical trial protocol in healthy adult subjects with proposed new formulation for further review by the committee.
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