Bharat Biotech's Covaxin is being indigenously developed by the firm in collaboration with the Indian Council of Medical Research (ICMR).
Bharat Biotech, which received the approval for phase 3 clinical trial of COVID-19 vaccine Covaxin on October 22, is aiming for June 2021 launch. Covaxin is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Bharat Biotech plans to test over 20,000 volunteers across 12-14 states in India, Sai Prasad, executive director, Bharat Biotech International Ltd, told The Indian Express.
"If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase 3 clinical trial — April, May, June, for example. That is for the full efficacy results," Prasad added.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The approval for late-stage clinical trial puts the Hyderabad-based firm behind the Serum Institute of India (SII), which is in the process of recruiting and vaccinating participants for the third phase of the clinical trial of its candidate, Covishield.
Prasad said that the government may approve Covaxin for emergency use. "We are committed to doing all our phase-1, phase-2 and phase-3 clinical trials in its entirety, but I think the government may also be considering emergency use approval,” Prasad said, adding that the firm is "not pushing for such approval."
"Our intent is to develop everything to its logical conclusion in terms of empirical evidence and data, and efficacy data and safety data. But there are discussions, I guess, within the government about that (emergency use approval)," he added.
Bharat Biotech on October 23 said it has successfully completed the interim analysis of Phase I and II trials and is initiating Phase-III trials in 26,000 participants.
"After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of Covaxin, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India," the vaccine maker said in a communication.
The vaccine maker had applied to the DCGI on October 2 seeking permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine.
It was asked to submit complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage.
In July, the DCGI had given permission to Bharat Biotech to conduct Phase 1 and 2 clinical trials of its COVID-19 vaccine.Click here for Moneycontrol's full coverage of the COVID-19 outbreak