Bharat Biotech commences Phase III trials for COVAXIN
Phase III trials will involve 26,000 volunteers across India who will receive two intramuscular injections, approximately 28 days apart
Bharat Biotech has commenced Phase III trials of COVAXIN today. The company informed that Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR.
A statement from the company apprises, “This is India’s first phase 3 efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive COVAXIN or placebo. The trial is double-blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group,” it adds.
“COVAXIN has been evaluated in ~ 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be adults over 18 years of age,” updates the statement.
COVAXIN, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) biocontainment facility. COVAXIN is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.
Speaking on the occasion, Suchitra Ella, Joint MD of Bharat Biotech said, “The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India, for a novel vaccine. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN has garnered interest from several countries worldwide for supplies and introduction.”
This multicenter phase III study will be conducted at the following sites across India. Participating volunteers who undergo vaccination in the Phase III trials will be monitored to detect the occurrence of COVID-19 disease.
|Sr No||City / State||Medical Center / Site|
|1.||Bhubaneswar||IMS SUM Hospital|
|2.||New Delhi||Guru Tej Bahadur Hospital|
|3.||Mumbai||Grant Government Medical College and Sir J.J. Group of Hospitals|
|4.||Guntur||Guntur Medical College|
|5.||Bhopal||Gandhi Medical College|
|6.||Ahmedabad||GMERS Medical College and Civil Hospital|
|7.||Uttar Pradesh||Aligarh Muslim University|
|8.||Hyderabad||Nizams Institute of Medical Sciences|
|9.||Rohtak||Pandit Bhagwat Dayal Sharma University of Health Sciences|
|10.||Goa||Redkar Hospital and Research Centre|
|11.||Guwahati||Guwahati Institute of Medical Sciences|
|14.||Mumbai||Lokmanya Tilak Municipal General Hospital And Medical College (Sion Hospital)|
|17.||Pondicherry||MG Medical College, Sri Balaji Vidyapeeth|
|18.||Bangalore||Vydehi Institute of Medical Sciences|
|19.||Vizag||King George Hospital|
|21.||Kolkata||ICMR-National Institute of Cholera and Enteric Diseases|
|22.||Chennai||Directorate of Public Health and Preventive Medicine, Teynampet|