India’s Drugs Controller General of India (DCGI’s) Subject Expert Committee (SEC) recommended granting of permission to conduct Phase III clinical trials for Bharat Biotech’s Covid-19 vaccine Covaxin.
The panel added that the recommendation is after assessing data from Phase I & II as well as animal challenge study.
In July, Bharat Biotech had received DCGI nod to conduct phase 1 and 2 clinical trials of an indigenous vaccine for COVID-19.
Covid vaccine – These are the latest updates
- The Oxford University COVID-19 vaccine undergoing Phase III clinical trials with British pharma giant AstraZeneca is doing “everything expected” which means good news in the fight against the deadly virus, an independent analysis said on Thursday. The vaccine, ChAdOx1 nCoV-19 and also known as AZD1222, is considered among the most advanced in the worldwide hunt for a viable vaccine against the novel coronavirus.
- The Russian Sputnik V vaccine against COVID-19 will be tested in India on 100 volunteers, the Indian Central Drugs Standard Control Organisation’s Drug Controller General (DCGI) told Russian news agency Sputnik on Thursday. DCGI has granted permission to pharmaceutical giant Dr Reddy’s Laboratories for conducting the tests. However, the date and time of the test will be determined by the company.
- Indian government expects a covid-19 vaccine to be ready for sale as early as December if clinical trials are successful, a senior health ministry official said. The Serum Institute of India has advanced the furthest in clinical trials in India, currently conducting phase 3 trials of Covidshield, which has been jointly developed by the UK’s AstraZeneca and the University of Oxford.
- AstraZeneca is conducting human trials with up to 50,000 participants in total in the UK, US, Brazil, Japan and South Africa, Serum Institute is conducting the trial in India with 1,600 patients. Early results from both companies’ trials are expected by December.
- Zydus Cadila and Bharat Biotech are on the verge of completing their phase 2 trials, with Bharat Biotech applying for DCGI approval to start the last stage.