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Regulator flags gaps in Bharat Biotech's TB vaccine trial

Regulator flags gaps in Bharat Biotech's TB vaccine trial
AI Summary

Indian regulators have paused Phase-III trials for Bharat Biotech's tuberculosis vaccine due to identified data gaps and a serious adverse event. The committee requires further validation of immunogenicity data before the trial can proceed.

Why it matters

As India faces a high tuberculosis burden, the delay of a promising vaccine candidate impacts public health timelines and clinical development standards.

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Confidence: 95%

The report relies on official committee minutes and regulatory findings, maintaining a factual tone.

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