Bharat Biotech, which had requested DCGI’s recommendation on the conduct of phase 3 clinical trials of its Covid-19 candidate vaccine, requested to submit complete knowledge on the protection and immunogenicity of the ongoing Phase 2 trial, as well as to provide some clarifications, before moving on to the next step.
The candidate vaccine, “Covaxin”, was developed through Bharat Biotech in collaboration with the Medical Research Council of India (ICMR). According to officials, Hyderabad-based vaccine manufacturer implemented the Indian General Drug Controller (DCGI) on 2 October. requesting permission to conduct a randomized, double-blind, placebo-controlled multicenter trial of his Covid-19 vaccine candidate.
Follow the coronavirus updates here
The firm’s request said the test would cover 28,500 subjects over the age of 18 and would be conducted at 19 sites, adding Delhi, Mumbai, Patna and Lucknow, in 10 states. According to sources, the phase 2 trial of Covaxin is underway and the current dose has still been administered to volunteers at some sites. “The company presented the protocol for the phase 3 clinical trial, as well as the provisional knowledge of the phase 1 and 2 clinical trials,” said an official. of the Central Organization for the Control of Medicines Standards (CDSCO) deliberated on the request on October 5.
“After careful deliberation, the committee found that the design of the Phase 3 review was acceptable in principle, with the exception of an explanation of the definition of asymptomatic, etc. “However, the test should be initiated at the appropriate dose known from knowledge of immunogenicity and Phase 2 protection. As a result, the company presents knowledge of immunogenicity and protection of the Phase 2 trial for review,” the panel said in its recommendations.
Click for full coronavirus coverage
During its discussion, the SEC also noted that the vaccine was well tolerated in all dose equipment and that no serious adverse occasions have been reported to date, one source said.
The non-unusual peak appearance caused pain at the injection site, which temporarily resolved, the source said.
The Phase 3 trial application proposed a 0. 5 ml dose on days 0 and 28, Resources said.
In addition, Bharat Biotech, a candidate vaccine developed through Zydus Cadila Ltd, is found in phase 2 human clinical trials.
The Pune-based Indian Serum Institute, which has partnered with AstraZeneca to manufacture the Oxford Covid-19 vaccine candidate, is conducting phase 2 and 3 human clinical trials with the candidate in India.
“item. title”
To continue reading, you want to disable adblocker and refresh the page.