Regulator flags gaps in Bharat Biotech's TB vaccine trial

▤ Summary

Bharat Biotech’s tuberculosis vaccine candidate MTBVAC hit a regulatory delay after India’s Subject Expert Committee asked for more safety and immunogenicity data. The panel also requested a revised phase III protocol with clearer endpoints and statistical design before it will consider approval. The company said the review is part of normal scientific scrutiny and that it will submit the requested information. The decision pushes back the start of the Indian phase III trial and extends the timeline for a potential new TB vaccine.

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