New Delhi, June 8 -- New Delhi: Trials of one of the world's most promising tuberculosis vaccines have hit a regulatory hurdle and temporary pause, with a top government panel calling for additional data before the critical final stage can begin.

The Subject Expert Committee (SEC) advising India's drug regulator noted data gaps and a serious adverse event (SAE) in the Phase-II trial data of Bharat Biotech's TB vaccine candidate, and ordered a detailed laboratory investigation to determine whether the event was linked to the vaccine, according to minutes of a 28 May meeting reviewed by Mint, and two officials familiar with the matter.

New drug and vaccine candidates go through three phases of testing before approval for mass use is grant...