Bharat Biotech to begin Phase-3 humans trials of COVAXIN candidate from 15 Oct in Punjab
Punjab CM Amarinder Singh gave stern directives about the poor not being pulled into trials without consent and understanding of the potential dangers.
Bharat Biotech is set to begin the third phase of human trials for its COVAXIN vaccine candidate against SARS-CoV-2, the virus that causes coronavirus disease (COVID-19). The trials will be held at three government medical colleges in Punjab, as per an official statement from the state government on Tuesday.
The Phase 3 trials are slated to begin on 15 October, according to a report by Asian News International, as disclosed by a government spokesperson after a virtual COVID-19 review meeting chaired by the Punjab Chief Minister Amarinder Singh. The trial will test the safety and efficacy of the shot, and will reportedly be conducted in about 25,000-30,000 volunteers.
The Punjab Chief Minister has instructed the Medical Education and Research Department to ensure full care and strict adherence to all the required precautions during trials, and that mandatory consent of all participants involved in the trial is taken. As per the ANI report, he followed these instructions up with stern directions to ensure the poor are not pulled into trials without consent, knowledge and understanding of the potential repercussions and dangers.
Bharat Biotech recently shared the results of their COVID-19 vaccine candidate safety trials in animals. The experimental shot, called 'COVAXIN', was found safe in rhesus monkeys that were vaccinated and exposed to the SARS-CoV-2.
The Drugs Controller General of India (DCGI), India's regulatory agency, granted approval for Phase I and II trials of the vaccine in June. Bharat Biotech, in a partnership with the National Institute of Virology, has concluded phase 1 human trials of their COVAXIN candidate at most of the 12 chosen centres as of 14 August. The results from the preliminary trial suggests that the vaccine is safe, principal investigators conducting the trials told the Economic Times. The second phase of human trials for the vaccine are likely to begin in the first week of September, as per the report.
COVAXIN is the first indigenously-developed vaccine against coronavirus. It is an inactivated vaccine candidate, designed to produce unique elements of the SARS-CoV-2 virus, which are used by the immune system to recognize a threat if the whole virus in ever encountered in the real world.
Volunteer in Oxford-AstraZeneca COVID-19 vaccine trial dies in Brazil; officials say testing to continue
Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment 'there have been no concerns about safety of the clinical trial'
Narendra Modi suggests developing COVID-19 vaccine distribution system on lines of holding elections
Stressing on speedy access to vaccines for citizens once ready, the prime minister also directed to involve all levels of governments and citizen groups in the distribution process
The J&J Phase 3 trial had started recruiting participants in September 2020, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world