COVAXIN, the country's first possible vaccine against COVID-19, will be tested on 1,125 healthy volunteers in two phases (phase 1 and 2)
Bharat Biotech on Friday announced that phase-1 clinical trials have been initiated on 15 July for "India's first Indigenous COVID-19 vaccine, COVAXIN". This is a randomised, double-blind, placebo-controlled clinical trial in 375 volunteers in India, the company said.
However, in filings to the drug controller and details available on the Clinical Registry of India, Bharat Biotech says that "the study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of three groups of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations." It is to involve a total sample size of 1,125 healthy volunteers in two phases (phase 1 and 2), with 375 in phase-1 involving age groups of 18-55, and 750 volunteers in the age group 12-65 in phase-2 study. It further puts the estimated duration of trials as one year and three months. Normally, there is also a phase 3 on a much larger group of people, but there is no information on this. Therefore, experts and those in the vaccine development space, feel, it may be reasonable to assume that it may well be by end of 2021, if not early 2022 before the vaccine may be ready.
The vaccine development has so far moved at a good pace. On June 29, just about 52 days since the Indian Council of Medical Research (ICMR) announced that it had partnered with Hyderabad-based Bharat Biotech to develop a fully indigenous vaccine using a strain isolated at ICMR's National Institute of Virology (NIV), Pune and that the strain had been transferred to Bharat Biotech, the company announced that a vaccine candidate COVAXIN had been developed and that it had received the approval of the Indian drug regulator to initiate phase I and II human clinical trials simultaneously in accelerated trials.
Phase-1 trial is for safety studies and phase-2 is for dosage and phase-3 is for vaccine efficacy in mass trials for different genetic types. What happens on this stage is crucial and will be closely watched. On July 4, the ICMR had said: "After intense characterisation and review of all data from Bharat Biotech, ICMR is supporting the clinical development as the vaccine candidate appears to be promising. Based on in-depth scrutiny of the available data from pre-clinical studies, the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trials."
In terms of other vaccines, many point to the Oxford Vaccine, being developed in the UK and to be manufactured in India by Serum Institute, as the most advanced at the moment as it is in phase-3 with trials on in South Africa and Brazil and to begin shortly in the UK. Some experts feel it may be reasonable to expect this vaccine to be ready by the end of this year though in this field nothing can ever be said with great certainty.