Bharat Biotech’s Covaxin gets nod for phase II trials
07 Sep 2020
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The Central Drug Standard Control Organisation (CDSCO) has accorded permission to Hyderabad-based Bharat Biotech to go ahead with phase II trials of Covaxin from 7 September, in a boost to development of indigenous Covid-19 vaccine.
The vaccine developed in partnership with the Indian Council of Medical Research, has completed phase 1 trials, which were conducted at several locations around the country, and is now ready for phase 2 trials.
The approval was given in the form of a letter written by Joint Drugs Controller Dr S Eswara Reddy to Bharat Biotech.
“This is to inform you that the subject proposal was examined in consultation with SEC (Covid-19) experts held through virtual meeting on September 3, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised in 4 days,”. the Director-General Health Services, New Delhi, in a statement issued on Friday said.
The phase 2 trials of BBV152, also called Covaxin, will reportedly be conducted on 380 participants, who will have to be screened four days after the vaccine is administered to them.
The Joint Drugs Controller said in its letter that the directorate had no objection to conducting “An adaptive, seamless Phase I, followed by Phase II randomised, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers”.
The letter mentions that Bharat Biotech's request for approval to initiate phase II clinical trials was examined in consultation with the Subject Expert Committee (COVID-19) experts held through virtual meeting on 3 September.
Phase 1 trials for Covaxin began on 15 July at 12 centres across the country. Healthy individuals were given two doses of the vaccine, with a gap of about 14 days. The phase 1 trials were conducted on over 350 people, and are still continuing.
In phase 1 trials, the volunteers were examined after every two days. The period will be extended to 4 days in phase 2 clinical trials.
Earlier, a report had said that the first phase trials of Covaxin had shown that the jab is both effective and safe against the novel coronavirus.
Health minister Harsh Vardhan said India’s first coronavirus vaccine 'Covaxin could be available by end of 2020.
A few weeks ago, the Indian drug regulatory authorities had also permitted Bharat Biotech to conduct a separate clinical trial of Covaxin through the skin. At present, the vaccine is being tested through intramuscular route, wherein it is injected directly into the muscle.
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