Bharat Biotech, which recently received approval to conduct Phase 3 human trials of India’s first indigenous coronavirus vaccine, Covaxin, has said it has been found to be safe without any major adverse impacts in the first two stages of trials and that its goal is to attain strong immune response rate in clinical trials.
Sai Prasad, executive director of Bharat Biotech International Limited (BBIL), said that Phase 1 data for neutralising antibodies has shown good immunogenicity.
“Covaxin was found to be safe without any major adverse events in the first two stages of the trials involving about 1,000 participants. Having received the approval from DCGI after assessing data from Phases 1 and 2 as well as the results of animal challenge study, we have moved into the last phase of trials,” he said.
“Our goal is to develop and deliver to the world a safe and effective vaccine. Phase 1 data for neutralising antibodies had shown good immunogenicity. Analysis of Phase 2 data is on,” he said when asked to comment on the view by some experts that early vaccines may not be fully effective.
“We have tested four different strains in India and done work on functional immunological assays, which will show us if this generates T-cell response, memory response,” he added.
The indigenous vaccine developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) is an inactivated intramuscular vaccine that works by injecting the inactivated version of Sars-CoV-2, the virus which causes Covid-19, into the body to develop an immune response.
“We follow a well-designed vaccine development protocol, and ensure each stage of our vaccine development is driven with a sole goal to attain a strong immune response rate in our clinical trials. When we do a trial design, we take into account the attack rates, the disease type, the ability of us to detect the disease and then the recruitment timelines,” Prasad said when asked about the comparison with vaccines being developed by several companies around the world.
The Hyderabad-based vaccine maker hopes to apply for regulatory approval for the vaccine in the second quarter of 2021.
“The Phase 3 efficacy data will be available approximately at the end of Q1 in 2021, after which we will apply for regulatory approval for release of the vaccine. We will continue on to Phase 4 which routinely follows up the participants for a few years,” Prasad said.
BBIL has initiated site preparatory exercises for Phase 3 clinical trials.
Recruitment of volunteers and dosage plan will begin this month.
“Phase 3 trials will be conducted across 25 sites in about 10-12 states. Two doses will be administered to each of the vaccine and placebo recipients. We plan to test 25,000-26,000 volunteers in the third phase of trials for Covaxin, involving about 1,000 participants enrolled per hospital,” Prasad said.
Asked about the timeline the company is looking at for the vaccine launch, Prasad merely said they were looking to apply for approval in 2021.
“Although speed is the need of the hour, we are committed to conducting our research in the most ethical and scientific manner. We are focused on safety and efficacy and we look to apply for approval in 2021,” he said.
The company is looking for vaccine supply to both government and private markets.
It is also in preliminary discussions with other countries for probable supply.
“Currently, we have built capacities to manufacture 200mn doses of vaccine. We plan to further enhance our capacities to 500mn doses,” Prasad said.
People wearing masks as a preventive measure against Covid-19 make their way through a market after Rajasthan assembly passed a bill to make wearing masks mandatory, in Jaipur yesterday.
