ICMR selected around 21 medical institutes across the country including Bhubaneswar's IMS and SUM Hospital where the Covaxin's third phase trial would be conducted. It is expected to cover around 28,500 subjects, aged 18 years and above, and will be conducted in 21 sites across ten states.
As per an official, India's first developed Covid-19 vaccine, Covaxin will commence its Phase III clinical trials at a private hospital in Bhubaneswar.
The major updates on Covaxin, developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) are as follows:
- Drugs Controller General of India permitted Bharat Biotech to conduct phase 3 clinical trials of Covaxin with certain conditions.
- Bhubaneswar's IMS and SUM Hospital is among the 21 medical institutes selected across the country by ICMR to conduct the third phase trial.
- Post first and second phase of the trial with demonstrable safety profile and immunogenicity, the large-scale efficacy trial involving thousands of volunteers has been planned now
- Half of the volunteers would receive placebo and the remaining half would be administered COVAXIN in this phase.
- The volunteers would be followed up over a considerable period of time to look at the efficacy of the vaccine in preventing the development of the Corona disease. Even health care workers would be recruited for the trial.
- The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
- The phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources told news agency PTI.
- In July, the Drug Controller General of India (DCGI) had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
- According to a Mint report, Bharat Biotech plans to launch its covid-19 vaccine—Covaxin by June next year, unless the government decides to give the vaccine an emergency use authorisation before that, based on data from earlier phases of clinical trials
- Meanwhile, Bharat Biotech is in discussions with more than 10 countries that have shown an interest in a potential COVID-19 vaccine it is developing with a government agency, a company executive told Reuters recently.