Indian biotechnology company Bharat Biotech has updated that its COVID-19 vaccine candidate Covaxin which also happens to be the country’s first indigenous coronavirus vaccine has been found to be safe without any major adverse impacts in both clinical trials (Phase 1 and 2).
The Hyderabad-based firm will now prepare to conduct comprehensive Phase 3 trials for its COVID-19 cure having already secured the necessary approvals.
Bharat Biotech’s CEO Mr. Sai Prasad mentioned that the Phase 1 trial data showed that the vaccine has 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,” Mr. Sai Prasad asserted.
Shrugging off comments from experts that early vaccines may be less effective, the Bharat Biotech’s CEO remarked that “our goal is to develop and deliver to the world a safe and effective vaccine. Phase 1 data for neutralizing antibodies had shown good immunogenicity. Analysis of Phase 2 data is on.”
“We have tested four different strains in India and done work on functional immunological assays, which will show us if this generates a T-cell response, memory response,” Bharat Biotech chief added.
Developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Covaxin 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.
Bharat Biotech expects 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,” Mr. Prasad updated.
The firm has already initiated site preparatory exercises for Phase 3 clinical trials with the recruitment of volunteers and dosage plan expected to happen later 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,” Bharat Biotech chief observed.
Commenting on a possible timeline for wide release, Mr. Prasad stated that “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.”
“Currently, we have built capacities to manufacture 200mn doses of vaccine. We plan to further enhance our capacities to 500mn doses,” Mr. Prasad updated.