Hyderabad: Bharat Biotech has announced the initiation of Covaxin phase III trials. The phase III trials, conducted in collaboration with ICMR, will include 26,000 volunteers across 25 centres in India. It is the biggest clinical trial performed in India for the Covid-19 vaccine.
This is India’s first phase 3 efficacy trial for the Covid-19 vaccine, and India’s highest ever phase III efficacy study. The Drugs Controller General of India has approved the trial.
Participating volunteers vaccinated in the Phase III trials will be tracked to identify the incidence of Covid disease over the next year. About 28 days apart, research volunteers will undergo two intramuscular injections.
Participants will be allocated 1:1 at random to obtain either two 6 microgram (mcg) Covaxin injections or two placebo shots. The trial is double-blinded, so that the investigators, the respondents and the organisation are not aware of who is assigned to which category.
With promising safety and immunogenicity results, Covaxin has been evaluated in approximately 1,000 subjects in phase I and II clinical trials. Volunteers who wish to participate in this trial should be adults over 18 years of age.
Bharat Biotech is developing Covaxin, India’s indigenous Covid-19 vaccine, in partnership with the National Institute of Virology (NIV) of the Indian Council of Medical Research (ICMR). The indigenous, inactivated vaccine is produced and manufactured in the high containment facility of Bharat Biotech’s BSL-3 (Bio-Safety Level 3). (INN)