Bharat Biotech's Indian COVID vaccine - Covaxin to launch in June 2021!
Galatta | Oct 27, 2020, 09:59 pm
With the entire world racing against time to register an effective vaccine against the COVID-19 Novel Corona Virus Pandemic, Russia has already registered two. However, the rest of the medical fraternity across the world are yet to accept these vaccines as they have not undergone the required Phase 3 clinical trials to show us the efficacy of the vaccine. There are quite a few other vaccine candidates which are in the late stage of testing and quite a few are already well into the Phase 3 trial stage. Meanwhile, India is developing a couple of vaccine candidates of its own. The vaccine candidate being developed by the Serum Institute of India (SII) has already begun recruiting volunteers for its Phase 3 trials and they are being vaccinated to get the trials underway.
In another piece of great news, we hear that the vaccine candidate being jointly developed by the Hyderabad-based Bharat Biotech, in association with the Indian Council of Medical Research's National Institute of Virology, has been granted permission to begin the Phase 3 of their clinical trials! This vaccine, named Covaxin, will have about 20,000 volunteers participating in the Phase 3 trials across 12 to 14 states in India, in over 21 centres across the country! Sai Prasad, the Executive Director of Bharat Biotech, says, "If we get all the approvals in place, I think Q2 of 2021, we could get the efficacy readout from our Phase 3 clinical trial - April, May, June, for example. That is for the full efficacy results." He also added, "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."
Sai Prasad, however reiterated that his company would not be pushing for that emergency approval by themself. He added, "Our intent is to develop everything to its logical conclusion in terms of empirical data, efficacy data and safety data. But, there are discussions I guess, within the government about that (emergency use approval)." A plan to enroll about 25,000 to 26,000 volunteers for the Phase 3 trial has been submitted to the Central Drugs Standard Control Organisation (CDSCO) and the DCGI, and they are also said to have accepted it. The number of testing centres might also be increased to 25 from the currently planned 21! The first 2 phases saw volunteers participating across 12 testing centres. There were some ripples earlier, when a letter to the government mentioned August 15th as the date of the Covaxin launch, which would have urged the trials to be fast-tracked. However, it was later revealed that the vaccine would not be launched, compromising on any safety or efficacy!