Zoom News : May 01, 2022, 01:04 PM
Government committee for TB vaccine rejected Serum Company's proposal and asked for safety and immunogenicity data. The company had submitted an application for emergency use permission for the TB vaccine about a month ago, after which it was rejected at a meeting of the Expert Action Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).
The number of TB patients and deaths are recorded in lakhs every year in the country. In the year 2021, 19.33 lakh new patients were found, which is about 19% more than the year 2020. Similarly, an increase of about 11% was also recorded in the TB mortality rate between 2019 and 2021. In the year 2020, 4.93 lakh people died due to TB infection. Therefore studies are being done to protect a large population from TB.
Study is going on 12,000 people, ICMR is also involved in the study
Test not done in India
The number of TB patients and deaths are recorded in lakhs every year in the country. In the year 2021, 19.33 lakh new patients were found, which is about 19% more than the year 2020. Similarly, an increase of about 11% was also recorded in the TB mortality rate between 2019 and 2021. In the year 2020, 4.93 lakh people died due to TB infection. Therefore studies are being done to protect a large population from TB.
Study is going on 12,000 people, ICMR is also involved in the study
- Teams from New Delhi-based Indian Council of Medical Research (ICMR) and Pune-based Serum Institute of India (SII) are involved in this. Recently, ICMR had given a statement that the third phase of trial on this vaccine would start on 12,000 people in six states of the country, which may take about two years to complete.
- The committee member and senior scientist said that on March 28, the Serum Company's application was received, in which a demand was made to allow emergency use of TB vaccine in the country for people aged six years or more.
- However, when it was considered in the meeting, there was a lack of scientific evidence, due to which it was not accepted.
Test not done in India
- According to sources, the serum company had sought permission for its use in India citing a study conducted in South Africa. There have been two trials on newborns. Whereas ICMR is conducting Phase III trials in India.
- Apart from these, two thousand people are being tested separately under the second and third phases in South Africa. The Committee observed that the Serum Company has not conducted any such test at the local level.