Bhubaneswar (Odisha) [India], November 21 : In phase 3, COVAXIN's effectiveness to prevent the disease (coronavirus) will be checked, said Dr. E Venkata Rao, Principal investigator of COVAXIN trial at Institute of Medical Sciences and SUM Hospital, Bhubaneswar, while adding that out of 1,000 people recruited, the vaccine will be given to 50 per cent of them and placebo to others.
"In phase 3, we will see if COVAXIN is effective enough to prevent the disease. Out of 1,000 people recruited, we will give the vaccine to 50 per cent of them and placebo to others," said Dr. Rao, Principal investigator of COVAXIN trial at Institute of Medical Sciences and SUM Hospital, Bhubaneswar.
"After the success of the Phase-1 and Phase-2 of this indigenously developed vaccine, it has come into phase-3. Phase-1 was for the safety profile to check whether the vaccine was safe for human beings. In Phase-2 we looked for immunogenicity. Phase-3 is crucial where we will be looking at the vaccine if it is effective enough in preventing the development of the disease," he added.
Dr. Rao further stated that a large number of subjects will be required for Phase-3 and probably the COVAXIN Phase-3 trial is the largest clinical trial in India.
"If the people who have got the vaccine among them, none of them are developing the disease and among the people who have not got the vaccine and are developing the disease then we can say that comfortably the vaccine is preventing the disease," said Dr. Rao.
In October, the Drugs Controller General of India (DCGI) gave permission to Bharat Biotech for conducting the Phase-III clinical trial for Covaxin.
According to the Subject Expert Committee (SEC), on October 5, the firm presented their data from the phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event-driven phase III clinical trial to assess the efficacy of the vaccine.
Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) for a country-made COVID-19 vaccine using the virus strain isolated by ICMR's National Institute of Virology (NIV) based in Pune.
The Phase III trials will involve 26,000 volunteers across India, the company said. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive COVAXIN™ or 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 1,000 subjects in Phase I and Phase II clinical trials, with "promising safety and immunogenicity data".