Updated: October 24, 2020 7:52:13 am
Covaxin: the country’s first indigenous vaccine is an inactivated one created from the infectious virus strain SARS-CoV-2.
BHARAT BIOTECH, who has received approval for late stage human trials for its Covid vaccine candidate, it expects to have it ready by June 2021, unless the government advances its launch through an emergency use authorization, according to a senior company official.
The Hyderabad-based firm plans to test more than 20,000 volunteers in 12-14 states for Covaxin, its indigenous candidate, Sai Prasad, CEO of Bharat Biotech International Ltd., told The Indian Express.
“If we get all the approvals, I think during the second quarter of 2021, we should get the efficacy reading from our phase 3 clinical trial: April, May, June, for example. That’s because of the total efficacy results, ”Prasad said.
Covaxin, developed in collaboration with the National Institute of Virology of the Indian Council of Medical Research, is an inactivated vaccine that is expected to work by injecting the “dead version” of the Covid-19 virus into the body to develop an immune response.
Bharat Biotech’s approval to conduct phase 3 trials currently places it behind the market-leading Serum Institute of India, which is said to be in the process of recruiting and vaccinating participants for the third phase of testing for their candidate. , Covishield.
Read | India has set aside $ 7 billion to vaccinate the world’s second-largest population
The results of the efficacy of a vaccine show whether it has been able to reduce the number of cases in the inoculated group. “We are committed to conducting all of our Phase 1, Phase 2 and Phase 3 clinical trials in full, but I think the government may also be considering approval for emergency use,” Prasad said.
However, he said the firm is not pushing for such approval. “Our intention is to develop everything to its logical conclusion in terms of evidence and empirical data, and efficacy data and safety data. But there are discussions, I guess, within the government about that (emergency use approval), ”he said.
The firm plans to enroll “25,000 to 26,000” participants across the country, including in Telangana, Tamil Nadu, Haryana, Maharashtra and Bihar, Prasad said. “This is what has been submitted to CDSCO (Central Medicines Standards Control Organization) and DCGI (Controller General of Drugs of India), and they have accepted it,” he said.
While the number of testing centers may increase, the target is about 25 clinical trial sites, he said. “For the last two months, we have been trying to establish and develop these sites … in 12 to 14 states of India as of now … it is well distributed between the north, south, east and west,” he said, He added that during the first two-phase, Covaxin was provided to volunteers at 12 sites.
“There will be quite a few new sites and there will also be quite a few new states, because the site selection for phase 3 is completely different from a phase 1 or phase 2. Obviously, we are looking at the capabilities and experience of the site, but also what is happening in terms of Covid-19 disease in those respective areas … it’s a multifaceted approach to selecting a site, ”said Prasad.
Other candidate vaccines in the fray include those from Zydus Cadila, which is close to completing phase 2 trials of ZyCov-D, and Russia’s Gamaleya Research Institute, which will soon begin phase 2/3 trials of Sputnik V in collaboration with Dr. Reddy’s. .
Covaxin became the subject of controversy in early July, when ICMR Director General Dr. Balram Bhargava wrote to lead investigators ahead of early-stage human trials, suggesting that the government was considering a release date. August 15 release.
Officials later clarified that the letter, which urged researchers to “expedite” all approvals and ensure subjects’ enrollment by July 7, was not intended to launch the vaccine at the cost of safety and security. effectiveness.
.
