Regulatory Roadblock for Zydus: CDSCO Panel Halts MMRV Vaccine Trial, Seeks Adult Data

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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