Home TRENDING Bharat Biotech Starts Phase III Trials for COVAXIN Today

Bharat Biotech Starts Phase III Trials for COVAXIN Today


Hyderabad, India, November 16, 2020: 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.

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. The trial has been registered at http://ctri.icmr.org.in/ and approved by the Drugs Controller General of India.
Participating Volunteers who undergo vaccination in the Phase III trials will be monitored over the next year to detect the occurrence of Covid disease.

Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 6 micrograms (mcg) injections of COVAXIN™ or two shots of a 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.

COVAXIN has been evaluated in ~ 1000 subjects in PhI and 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.

COVAXIN™ is still an investigational product. The participation of this trial may contribute to the licensure of COVAXIN.
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). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment 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.

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and WHO Pre-qualifications.

Located in Genome Valley, the hub for the global biotech industry, the company has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.
Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

The company is proficient in conducting extensive multi-center clinical trials, having completed more than 75 trials enrolling more than 300,000 participants globally.

Our commitment to global social innovation programs and public-private partnerships resulted in the introduction of path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting Polio, Rotavirus, and Typhoid infections respectively. Bharat Biotech has successfully partnered with NIV-ICMR having developed JENVAC®, a licensed Japanese Encephalitis vaccine.

The 2019 acquisition of Chiron Behring (CHIRORAB®), has positioned Bharat Biotech as the largest Rabies vaccine manufacturer in the world.

(press note issued by Bharat Biotech)


Please enter your comment!
Please enter your name here