Permission to carry out clinical trials of Covovax cannot be given: Experts Panel
Pune-based Biotechnology company Serum Institute of India (SII), which was behind Covishield vaccine doses, has joined hands with US-based vaccine maker Novavax, Inc to manufacture the vaccine doses, which will be supplied in the name of Covavax.
The SII had applied for permission to carry out the vaccine trials on children of 2-17 age. The Government panel is said to have refused the application and directed the company to finish the trials on adults first.
It is said that, as the trials will be conducted on children, the union government's experts panel has sought the data on the trials on the adults first.
SII had sought permission from the Drugs Controller General of India (DCGI) to carry out the clinical trials on children across 10 sites. The application was filed on Monday and the committee examined the application and gave its opinion that the permission should not be given.
The Pune-based pharma giant had started its clinical trial on people above the age of 18 years for Covavax in March and the company is in plans to start clinical trials of children from August and roll out the vaccine doses soon. As part of this, the biotech company applied for clinical trials.
The SII had applied for permission to carry out the vaccine trials on children of 2-17 age. The Government panel is said to have refused the application and directed the company to finish the trials on adults first.
It is said that, as the trials will be conducted on children, the union government's experts panel has sought the data on the trials on the adults first.
SII had sought permission from the Drugs Controller General of India (DCGI) to carry out the clinical trials on children across 10 sites. The application was filed on Monday and the committee examined the application and gave its opinion that the permission should not be given.
The Pune-based pharma giant had started its clinical trial on people above the age of 18 years for Covavax in March and the company is in plans to start clinical trials of children from August and roll out the vaccine doses soon. As part of this, the biotech company applied for clinical trials.