Coronavirus Covid-19 vaccine in India: Phase 3 human trials of Covaxin are said to be the largest as well as the first phase 3 efficacy study for any Covid-19 vaccine in India.
Coronavirus Covid-19 vaccine in India: Haryana Health Minister Anil Vij was inoculated with a trial dose of India’s indigenous experimental Coronavirus vaccine candidate Covaxin on Friday. Vij was administered the trial dose at a hospital in Haryana’s Ambala as phase 3 human trial of Covaxin commenced in the state. Earlier on November 18, Vij had offered himself as the “first volunteer” for the Phase 3 clinical trial of Covaxin.
The video of the Haryana Health Minister being administered the trial dose of Bharat Biotech’s Covaxin was posted by news agency ANI on its Twitter handle. The video shows the jab was injected into Vij’s left hand. With this, the late-stage large scale clinical trials of Covaxin have commenced in Haryana today. Notably, Phase 1 human trial of Covaxin was conducted at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences or PGI, Rohtak in Haryana.
He had offered to be the first volunteer for the third phase trial of Covaxin, which started in the state today. pic.twitter.com/xKuXWLeFAB
— ANI (@ANI) November 20, 2020
Earlier on November 18, the minister had tweeted saying that he offered to become the first volunteer to be vaccinated for the phase 3 human trial of the Covaxin. Covaxin Covid-19 vaccine candidate is being developed by Hyderabad-based Bharat Biotech along with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune.
Phase 3 human trials of Covaxin are said to be the largest as well as the first phase 3 efficacy study for any Covid-19 vaccine in India. During phase 3 human trials of Covaxin, volunteers will be administered two intramuscular injections around 28 days apart.
As many as 1000 volunteers enrolled and were evaluated for safety and immunogenicity data during phase 1 and Phase 1 human trials of Covaxin. After successfully completing the interim analysis from the Phase 1 and 2 human trials of Covaxin, Bharat Biotech received approval from the Drugs Controller General of India (DCGI) for Phase 3 clinical trials with 26,000 participants in over 25 testing sites across India. Volunteers are required to be aged over 18 to take part in human trials of Covaxin.