Hyderabad Vaccine manufacturer Bharat Biotech announced that it has begun Phase III trials of India’s first indigenous vaccine ‘Kovacine’ for Kovid-19. Phase-3 trials include 26,000 volunteers from across India. It is being operated in association with the Indian Council of Medical Research (ICMR).
The Hyderabad-based company said that this is India’s first Phase-3 efficacy study for the Kovid-19 vaccine, and the largest Phase-3 efficacy trial to date.
Volunteers involved in the trial will be given two intramuscular injections within approximately 28 days. Participants will be given covaxin or placebo, either voluntarily (randomly). The test has been double blinded. That is, investigators, participants and the company will not know which group has been vaccinated.
The test is being done in 22 institutes in India, including the All India Institute of Medical Sciences (AIIMS) and Guru Tegh Bahadur Hospital in New Delhi. Apart from this, Aligarh Muslim University, Grant Government Medical College and Sir J.J. Group of Hospitals, Lokmanya Tilak Municipal General Hospital and Medical College (Sion Hospital) are also included in this.
Volunteers participating in this will be closely monitored.
Bharat Biotech Covaxin has been developed in partnership with ICMR-National Institute of Virology (NIV). Bharat Biotech is the only vaccine company in the world, which has a biosafety level-3 (BSL3) production facility.
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