Serum’s new TB vaccine denied approval

India's top drug regulator has denied approval for Serum Institute of India Pvt. Ltd.'s new tuberculosis vaccine, calling the test data "not adequate and conclusive", according to a document and two government officials familiar with the matter.

- Priyanka Sharma

The Special Subject Expert Committee on Vaccines at the Drugs Controller General of India (DCGI) last month found that the main studies failed to clearly demonstrate that the recombinant BCG (rBCG -VPM1002) was effective, according to the minutes of the meeting reviewed by Mint.

A recombinant BCG vaccine is a genetically modified version of the traditional TB shot that is based on a weakened strain of Mycobacterium bovis.

The regulator found the Serum Institute of India's (SII's) specialized, later-stage analysis to be unreliable, asking the company to conduct a new, larger study to get clear and convincing proof that the vaccine works before seeking approval for public use.

Tuberculosis (TB), mainly