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Covid-19: Bharat Biotech Enrolls 25,800 Volunteers for Covaxin Phase 3 Clinical Trials | India News


HYDERABAD: Bharat Biotech International Limited announced on Thursday the successful completion of the enrollment of volunteers for phase 3 clinical trials of its locally manufactured Covid-19 vaccine, ‘Covaxin’.
“Covaxin successfully completes phase 3 clinical trial enrollment of 25,800 volunteers,” Suchitra Ella, Bharat Biotech Deputy General Manager said in a statement while expressing gratitude to the principal investigators and healthcare workers for their support in their public-private partnership vaccine program.
“My deep appreciation to all volunteers for placing their trust and expressing their public health volunteerism in favor of the vaccine in the phase 3 clinical trials of the first fully indigenous Covid-19 vaccine from India,” added Ella.
The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV).
Covaxin has been evaluated in approximately 1,000 subjects in phase I and phase II clinical trials, with promising results for safety and immunogenicity, with acceptance in international peer-reviewed scientific journals, the company said in a statement.
Covaxin is a highly purified and inactivated 2-dose SARS-CoV2 vaccine manufactured on a Vero cell manufacturing platform with an excellent safety record of more than 300 million doses, he added.
Covid-19 vaccines ‘Covishield’ from the Serum Institute of India and ‘Covaxin’ from Bharat Biotech received permission for restricted use in an emergency situation by the Controller General of Drugs of India (DCGI) on January 3.
Hours earlier, the Union’s health minister, Dr. Harsh Vardha, said that the Covid-19 vaccines ‘Covishield’ and ‘Covaxin’ are about to be available in the country. The Health Minister, while addressing a press conference, said: “The Covid-19 vaccines ‘Covishield’ and ‘Covaxin’ are about to be available in the country. Our efforts are to ensure the smooth delivery of the vaccine in the last mile. ”

Times of India