Context:

• Indian Council of Medical Research (ICMR) launched India’s first large-scale trial for two new tuberculosis (TB) vaccines.

Stats:

• As per the 2018 annual report of the Central TB division of Ministry of Health and Family Welfare, the incidence of TB was nearly 2.8 million annually, and the incidence of multidrug-resistant TB was 1,47,000 per year.
• The total number of deaths because of TB (excluding HIV) was 4,23,000, and the incidence of HIV-TB was 87,000 per year.
• India contributes to 27 per cent of the global TB burden; the highest share globally.
• That is why, in 2017, the central government had committed itself to eliminating TB by 2025.

What is TB?

• Tuberculosis (TB) is caused by bacteria (Mycobacterium tuberculosis) that most often affect the lungs. Tuberculosis is curable and preventable.
• Spread- TB is spread from person to person through the air. When people with lung TB cough, sneeze or spit, they propel the TB germs into the air. A person needs to inhale only a few of these germs to become infected.
• About one-third of the world’s population has latent TB, which means people have been infected by TB bacteria but are not (yet) ill with disease and cannot transmit the disease.

Symptoms:

• TB disease in the lungs may cause symptoms such as
• a bad cough that lasts 3 weeks or longer
• pain in the chest
• coughing up blood or sputum (phlegm from deep inside the lungs)

Other symptoms of TB disease are:

• Weakness or fatigue
• Weight loss
• No appetite
• Chills
• Fever
• Sweating at night.

TB and HIV Coinfection:

• Tuberculosis is a serious health threat, especially for people living with HIV.
• People living with HIV are more likely than others to become sick with TB.
• Someone with untreated latent TB infection and HIV infection is much more likely to develop TB disease during his or her lifetime than someone without HIV infection.
• Among people with latent TB infection, HIV infection is the strongest known risk factor for progressing to TB disease.
• A person who has both HIV infection and TB disease has an AIDS-defining condition.

Why New Vaccines:

• Scientists at the Indian Council of Medical Research have felt a critical need for new TB vaccines that are more effective than the Bacille Calmette-Guerin (BCG) vaccine.

Which are Vaccines?

• There are two vaccines being tested in the latest trial:
• Immuvac (also known as mycobacterium indicus pranii or MIP), which is manufactured by Cadila Pharmaceuticals in Ahmedabad, and
• VPM1002 manufactured by Serum Institute of India in Pune.

What are Phases of trials:

• Typically, vaccine trials have three phases. During Phase 1, small groups of people receive the trial vaccine.
• In Phase 2, the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended.
• In Phase 3 the vaccine is given to several thousands of people and tested for efficacy and safety.

Current phase of TB vaccine:

• Phase 3 vaccine trial where the safety and efficacy of the two TB vaccines are being studied in comparison to the placebo in a larger population.
• Depending on the results, the recommendations would be sent to the Union Ministry of Health and Family Welfare.
• Both vaccines are being manufactured by Indian pharmaceutical companies. The price of the vaccines would be decided by the government.