The Subject Expert Committee (SEC) has recommended phase 1 clinical trials of Reliance Life Sciences’ vaccine candidate against the COVID-19 disease Reported a news agency ANI on Friday. According to reports, the proposed vaccine candidate includes two doses and is based on a recombinant protein platform.
As the SEC has recommended phase 1 trials, the next step for Reliance Life Sciences is to receive approval from the Drugs Controller General India (DCGI). The company can begin the first phase of clinical trials for its vaccine candidate once the country’s top drugs regulator grants permission.
The exercise will be conducted at 10 sites even if Reliance Sciences itself is a testing centre for Covid-19, including those in Delhi, Maharashtra, Tamil Nadu and Andhra Pradesh.
For nearly two months phase 1 trial lasts, or 58 days, and is conducted to notice the highest number of doses that most patients can tolerate.
So far, the DCGI has granted Emergency Use Authorisation (EUA) to six vaccines, of which two are indigenous while the rest are foreign-made. Covaxin and Covishield were the first two shots to receive EUA, followed by Sputnik V, Moderna, Johnson & Johnson and ZyCoV-D respectively. Among these, Covaxin and ZyCoV-D are made in India vaccines.
Reliance Life Sciences is a research-driven organisation for emerging business opportunities in biotherapeutics, pharmaceuticals, clinical research, molecular medicine etc.
While the name itself suggests, it comes under the Promoter Group of Mukesh Ambani’s Reliance Industries Limited