The Subject Matter Expert Committee (SEC) of the Comptroller General of Drugs of India (DCGI) recommended the granting of permission to conduct Phase III clinical trials for Bharat Biotech’s Covid-19 Covaxin vaccine.
The panel added that the recommendation is after evaluating the Phase I and II data, as well as the animal challenge study.
In July, Bharat Biotech had received approval from DCGI to conduct Phase 1 and Phase 2 clinical trials of a indigenous vaccine for COVID-19.
Covid vaccine: these are the latest updates
- The University of Oxford’s COVID-19 vaccine in phase III clinical trials with British pharmaceutical giant AstraZeneca is doing “everything expected,” which is good news in the fight against the deadly virus, an independent analysis said Thursday. The vaccine, ChAdOx1 nCoV-19 and also known as AZD1222, is considered one of the most advanced in the global search for a viable vaccine against the new coronavirus.
- The indigenously developed Zydus Cadila vaccine candidate is also in Phase 2 of human clinical trials.
- Russia’s Sputnik V vaccine against COVID-19 will be tested in India on 100 volunteers, the Controller General of Drugs (DCGI) of the Central Drug Control Organization of India told Russia’s Sputnik news agency on Thursday. DCGI has granted permission to the pharmaceutical giant Dr Reddy’s Laboratories to conduct the tests. However, the company will determine the date and time of the test.
- The Indian government expects a covid-19 vaccine to be ready for sale from December if clinical trials are successful, a senior Health Ministry official said. The Serum Institute of India has advanced further into clinical trials in India, and is currently conducting phase 3 trials of Covidshield, which has been jointly developed by AstraZeneca of the UK 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. The first test results of both companies are expected in December.
- Zydus Cadila and Bharat Biotech are about to complete their phase 2 trials, and Bharat Biotech requested approval from DCGI to begin the last phase.
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