Bharat Biotech has recruited 23,000 volunteers and continued to progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its COVID-19 vaccine Covaxin across multiple sites in India, the company said.
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV).
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
It was also the largest phase III efficacy trial ever conducted for any vaccine in India, the company said.
Thanking volunteers for their participation in the trials, Suchitra Ella, Joint Managing Director of Bharat Biotech said the volunteering spirit is a great morale boost for India and the world.
"We thank all the principal investigators, doctors, medical staff and the hospitals for their cooperation and support in taking the phase III trials forward in 23,000 volunteers in India," she said.
"We continue our progress towards achieving the goal of 26,000 participants for Phase-3 clinical trials of Covaxin," Ella added.
Covaxin has been evaluated in approximately 1,000 subjects in Phase I and II clinical trials, with promising safety and immunogenicity results and acceptance in international peer reviewed scientific journals.
The indigenous, inactivated vaccine is manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility here, one of its kind in the world, the company said.
On Saturday, an expert panel of the country's central drug authority had recommended granting permission for restricted use of Covaxin in emergency situation.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had recommended 'grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech', the health ministry had stated.
According to sources, the committee had also stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the it as and when available.
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