Vaccine maker Bharat Biotech plans to conduct Phase III clinical trial for COVID-19 vaccine candidate Covaxin from November.
The company, which is developing the vaccine in collaboration with the Indian Council of Medical Research (ICMR), intends to conduct the trial on 26,000 volunteers across 25 cities in the country, sources said.
This move follows the company getting Drugs Controller General of India (DCGI) approval to conduct the Phase III clinical trial for Covaxin.
At its meeting on October 20 a Subject Expert Committee (SEC) of the DCGI, giving the approval, said “after detailed deliberation and based on available evidences, the Committee [has] recommended for grant of permission to conduct [of] Phase III clinical trial,” subject to certain conditions.
The company had submitted to the SEC data from the Phase I and II trials along with animal challenge data in two species, including NHP, on the inactivated coronavirus vaccine (BBV152) along with the proposal to conduct event driven Phase III clinical trial to assess the efficacy of the vaccine.
Earlier, on October 5, when the company presented Phase III clinical trial protocol, the SEC took note of the interim data of Phase I and II clinical trial that were also submitted. “After detailed deliberation the Committee opined that the design of the Phase III study is in principle satisfactory except for clarification on definition of asymptomatic,” it had then said.
The study should be initiated with appropriate dose identified from the Phase II safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from Phase II trial for consideration,” the Committee had said.
Besides Covaxin, for which the SARS-CoV-2 strain was isolated in ICMR- National Institute of Virology, Pune and transferred to Bharat Biotech, other Covid-19 vaccine candidates whose clinical trials are underway in the country include those by Serum Institute of India. Drugmaker Dr. Reddy’s Laboratories had also recently got DCGI approval to conduct clinical trials of Russia’s Sputnik-V vaccine.