New Delhi: The expert panel of the Drugs Controller General of India (DCGI) has asked for more safety data from the makers of two tuberculosis (TB) vaccine candidates—VPM1002 and Immuvac—after reviewing the results of their phase-3 trials.
VPM1002 is a recombinant BCG vaccine (a modified version of the BCG vaccine) being developed by Serum Institute of India. Immuvac is being developed by Cadila Pharma under the technical guidance of the government’s Indian Council Medical Research (ICMR).
The expert panel said they want to see more safety data, according to the minutes of a meeting of the subject expert committee (SEC) held on 25 February.
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The phase-3 clinical trials for both vaccines are aimed evaluating the efficacy and safety of the jabs in preventing the spread of TB among healthy household contacts of newly diagnosed TB patients.
TB is the biggest killer among communicable diseases in India.
Government health officials detected as many as 719,000 new cases during a short, 100-day TB camp held last year, in addition to 2.6 million cases notified over the year. The government has now decided to extend the campaign to all the districts of the country.
India aims to eliminate TB by end of this year, five years ahead of the United Nations’ Sustainable Development Goals (SDG) deadline of 2030. But the task has become challenging in the absence of a protective TB vaccine.
“These studies are being done, and we are expecting good outcomes. Disease elimination is achieved on the basis of very effective vaccines, for example in case of polio, small pox etc. In the ongoing trials in India so far we haven’t achieved that level of protection,” said an official who participated in the SEC meeting.
The official said both the vaccines are being researched by ICMR for efficacy.
“The recombinant BCG vaccine (VPM1002) which is under trial is being produced by Serum Institute of India, while Immuvac (heat-killed suspension of mycobacterium) vaccine is being produced by Cadila Pharma,” the official added.
“Both the vaccines are being tried to look at the prevention of TB disease. Though one of them gave satisfactory results, but still we are evaluating for more good results. It is now up to ICMR to take it forward,” said the official.
Queries sent to the drugmakers mentioned above and the health ministry remained unanswered at the time of publishing.
The government is leveraging RT-PCR machines used during the covid pandemic for screening people for TB. Indigenous diagnostic kits developed by ICMR not only reduce the cost for TB detection but also improve efficiency by conducting 32 tests in one go In India.
TB drugs are purchased by the government and provided free of cost to patients both in government and private hospitals. Last year, the government approved a six-month multidrug-resistant TB regimen called “BPaL” (Bedaquiline, Pretomanid and Linezolid), which has shown a very high success rate and treatment outcome, according to the health ministry.
