Covaxin update: Days after DCGI nod, Bharat Biotech completes enrolment of volunteers for Phase III clinical trials

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Covaxin News Update Vaccine Efficacy“My deep appreciation to all the volunteers for reposing trust and expressing Pro Vaccine Public Health Volunteerism in Phase 3 clinical Trial of India’s first fully indigenous Covid-19 vaccine. Thank You India,” Suchitra Ella, Joint Managing Director, Bharat Biotech International Limited said.Bharat Biotech has successfully completed the enrolment of 25,800 volunteers for Phase 3 human trials for Covid-19 vaccine Covaxin. The announcement of successful completion of volunteer enrolment for Phase-3 Clinical trials of India’s first indigenous Covid-19 vaccine came days after the Drugs Controller General of India (DCGI) gave restricted emergency approval to the Hyderabad-based pharmaceutical firm.

“We sincerely express our gratitude to clinical trial sites, Principal investigators, and healthcare workers for their relentless support and trust in our Public-Private Partnership vaccine discovery. My deep appreciation to all the volunteers for reposing trust and expressing Pro Vaccine Public Health Volunteerism in Phase 3 clinical Trial of India’s first fully indigenous Covid-19 vaccine. Thank You India,” Suchitra Ella, Joint Managing Director, Bharat Biotech International Limited said.

On January 3, the Ministry of Health and Family Welfare stated that Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains.

Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, the Ministry of Health and Family Welfare stated on January 3.

The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue, the Ministry of Health and Family Welfare stated.

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