On July 15th, the Indian Council of Medical Research (ICMR) has launched the biggest ever trial of Tuberculosis (TB) vaccines in the country. It has started testing two new TB vaccines.
- As per the data from the Central TB division of the Ministry of Health and Family Welfare, there are 2.8 million incidences of TB cases in the country 1,47,000 multi-drug resistant TB cases.
- Deaths due to TB alone are 4,23,000 and HIV-TB are 87,000.
- India has a higher share of 27%, of TB burden in the world.
- In this scenario, the government committed itself to eradicate TB in the country by 2025.
- The two new vaccines, if successful, will be the country’s main weapons against the spread of multi-drug resistance TB.
The Need for New Vaccines
- TB treatment involves multi-drug course over a period of six months. It is longer for multi-drug resistant TB. Any slip up in the treatment will lead to the recurrence of TB and have devastating consequences.
- The TB vaccine that is currently used under the immunisation programme is the Bacille Calmette-Guerin (BCG). It is given during birth or in the first year. The vaccine is over 100 years old.
- Thought the vaccine protects the infants and children from severe forms of TB, it gives less protection against pulmonary diseases in adolescents and adults.
- It is for this reason that the scientists from the ICMR felt the need for new vaccines.
Vaccines on Trial
The vaccines that are being used on trial are:
- Immuvac – which is also known as mycobacterium indicuss pranii or MIP. It is manufactured by Cadila Pharmaceuticals in Ahmedabad and
- VPM1002 – manufactured by Serum Institute of India, Pune
- In general, vaccine trials are done in three phases.
- In Phase 1, small groups of people will receive the trial vaccine. In Phase 2, the vaccine is given toe people for whom the new vaccine is intended. In phase 3, the vaccine efficacy is tested by giving it to thousands of people.
- The Indian trial stands out, as nowhere in the world two new vaccines are trialed in phase 3. It is only in India that Two New TB Vaccines will be trialed in one go.
- For the trial, 12000 healthy households with newly diagnosed pulmonary TB will be enrolled from cross Delhi, Telangana, Maharashtra, Odisha, Karnataka, and Tamil Nadu.
- 2000 candidates from each state will be enrolled for the trial and the efficacy of both the vaccines will be tested over a period of three-years.
- After testing for the efficacy, depending on the results, ICMR will recommend the vaccines to the Ministry of Health.
- The vaccines being developed by Indian Pharmaceutical companies, the price of the vaccines will be decided by the government.
There is a sense of urgency among scientists to introduce new vaccines and it is rightly so. The multi-drug resistant is hard to treat and casualties are higher. Hope with the new vaccines will be successful and will be introduced in the immunisation programme.