The drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO).
Covid-19 drug candidate has been developed by VINS Bioproducts in collaboration with Centre for Cellular and Molecular Biology and University of Hyderabad
According to the Hyderabad-based company, emergency use will be as per the provisions of the new drug and clinical trials rules, 2019 under the Drugs and Cosmetics Act
As part of the review process, the drug major will present the safety profile of phase 2 study, and interim data of phase 3 trial, which is expected to be complete by February 21
The nasal vaccine is different from the two intramuscular vaccines which recently got approval, due to being non-invasive, needle-free, not requiring trained healthcare workers, eliminating needle-associated risks, and suitable for children and adults, having scalable manufacturing.
The Nation's first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila has been approved by Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials
"Following the emergency use permission, the company is in a position to meet any production requirement that the government may have at this time,” company officials said
While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses
This is a major relief for India which has the second highest number of infections in the world, after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.
"SII has applied for emergency use authorisation to DCGI. The application will be reviewed by the expert committee and after that final call will be taken," a senior government official confirmed ANI.