CDSCO panel directs SII to submit safety and immunogenicity data for TB vaccine

This came in line with the proposal presented by vaccine major Serum Inst. of India for grant of emergency use authorization for rBCG vaccine (VPM1002) for prevention of Tuberculosis in ≥6 years of age before the committee.

Tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. Tuberculosis commonly affects the lungs, but can also affect other parts of the body. It spreads from person to person through the air, when people who are infected with TB infection cough, sneeze or otherwise transmit respiratory fluids through the air.

According to the annual TB report released by Union Health Minister Mansukh Mandaviya, the number of tuberculosis cases in India has seen a 19 per cent rise in 2021 over the previous year, and there has been an increase in the mortality rate due to all forms of TB between 2019 and 2020 by 11 per cent.

BCG, or bacille Calmette-Guerin, is a vaccine for tuberculosis (TB) disease. Recombinant BCG vaccines are manufactured through advanced technology that allows the insertion of foreign genes, or overexpression of native genes, into the BCG vaccine.

Earlier, the Medical Dialogues Team had reported that the Serum Institute had applied to the Drugs Controller General of India seeking emergency use authorisation for its recombinant BCG (rBCG) vaccine for the prevention of tuberculosis.

The EUA application was submitted on March 22 by Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII).

In continuation, at recent SEC meeting for for Biologicals & PAC proposals held on 26.04.2022, the expert panel extensively reviewed the proposal presented by vaccine major Serum Inst. of India for grant of emergency use authorization for rBCG vaccine (VPM1002) for prevention of Tuberculosis in ≥6 years of age.

At the meeting, the firm presented Phase-IIa & IIb clinical data in infants carried out at South Africa for prevention of TB in infants. In addition, the firm stated that a Phase II/III trial with the objective of Prevention of recurrence of TB in 2000 adult participants is ongoing.

The firm also stated that Phase III clinical trial of rBCG vaccine being conducted by ICMR in 12000 participants of age ≥6 years healthy household contacts in the country is ongoing & ICMR is yet to submit the clinical trial data.

In view of the vaccine major SII's justification, the committee noted that, the firm has requested emergency use authorization for rBCG vaccine in age group age ≥6 years of age for prevention of TB in children based on the Phase IIb trial conducted in Africa and firm has not conducted local clinical trial in proposed age group and indication in the country.

After detailed deliberation, the committee recommended that firm should submit safety and immunogenicity data in proposed indication & age group for consideration of its proposal.