**2. Need of research on new TB vaccine**

In recent decades, advanced diagnosis and treatment method of TB has reduced the mortality rate up to significant level but TB still exists in world population causing extensive human suffering, economic burden led to global inequity. There are neonatal BCG vaccines that can prevent infants and young children from severe forms of TB but this vaccine is unable to show its effect in adolescents and adults who are crucial in TB transmission. We need to develop new efficient vaccines which could work in all age group people that may assist to fulfill the WHO end TB strategy that aims to reduce the TB mortality and TB incidences by 95% and 90% respectively worldwide.

Now, WHO is putting much efforts to produce TB vaccines and the Product Development for Vaccines Advisory Committee (PDVAC) is asking to develop a WHO preferred Product Characteristics (PPC) for new TB vaccines. The WHO's PPC data was established to document the crucial and priority requirements for vaccines which may show better safety and efficacy compared to BCG vaccine which is given to neonates and infants against pulmonary TB in adults, and new TB vaccines.

The major vaccine platforms like whole-cell vaccines, adjuvanted proteins, and recombinant subunit vector vaccines, are being considered in the pipeline of TB vaccine development. Now focus is on TB treatment in adolescents and adults by developing an effective candidate vaccine that may also replace the BCG in early life immunization. Many other aspects are in consideration in vaccine development, such as BCG boosters, reduction of treatment period using immunotherapeutic adjuncts and vaccine to prevent diseases reoccurrence in TB patient.

In recent developments, as per WHO report, there is TB vaccine candidate (M72/AS01E) developed by the pharmaceutical company GlaxoSmithKline, in partnership with AERAS and was observed substantially effective against Tuberculosis disease and these results came out in a Phase IIb trial carried out in Kenya, South Africa and Zambia in patients having latent tuberculosis. This vaccine was found with 50% efficacy over about 3 years of continuous monitoring.
