Hyderabad: Bharat Biotech has announced the commencement of Phase III trials of COVAXIN today. The Phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India.
Moreover, it will be India’s first phase III efficacy study for a COVID-19 vaccine ever conducted in India. The trial was approved by the Drugs Controller General of India. Volunteers who undergo vaccination in the Phase III trials will be monitored over the next year to detect the occurrence of COVID-19.
The volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 6 micrograms (mcg) injection of COVAXIN or two shots of a placebo. The trial is double-blinded such that the investigators, participants and company will not be aware of who is assigned to which group.
COVAXIN has been evaluated in 1000 subjects in Phase I and Phase II clinical trials, promising safety and the data proved the development of immunogenicity in volunteers. Volunteers who wish to participate in this trial should be adults over 18 years of age.
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The vaccine is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). 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.
Bharat Biotech received more than 140 global patents, has a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and World Health Organisation pre-qualifications.
Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech had developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.
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