Phase 2 and 3 clinical trials of Bharat Biotech’s Covaxin in the 2-18 age bracket will begin in June, sources from the Hyderabad-based vaccine maker said.
Covaxin, developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), is used in adults in India’s ongoing Covid-19 vaccination campaign. Earlier this month Bharat Biotech has been given permission the Phase 2/3 clinical study with Covaxin in the age group 2 to 18 years.
Bharat Biotech sources told India Today that Phase 2/3 for children will begin in June. Dosing starts in June and ends in mid-July. The youngest child enrolled in the clinical trial is a two-year-old, added Bharat Biotech. Coronavirus updates on May 24th
The study will be carried out on 525 subjects at different locations, including AIIMS, Delhi, AIIMS, Patna and the Meditrina Institute of Medical Sciences, Nagpur. In the study, the vaccine will be given intramuscularly in two doses on day 0 and day 28.
See also: Covid-19 In Children: Here’s How To Identify Symptoms And What Parents Should Know
Vaccine for children
The Indian drug controller approved Bharat Biotech’s Covaxin on May 13 to conduct Phase 2-3 clinical trials in children ages 2 to 18 years old.
After a critical review, DCGI accepted the recommendation of the expert committee (SEC) on Covid-19 and granted permission to conduct the phase 2-3 clinical trial with Covaxin in the age group from 2 to 18 years.
Hyderabad-based Bharat Biotech had previously proposed to conduct the Phase 2-3 clinical trials with Covaxin in the age group from 2 to 18 years. In the study, the Covaxin shot is given by the intramuscular route in two doses divided over 28 days.
As a swift reaction from the regulatory authorities, the proposal was discussed in the Subject Expert Committee (SEC) at the Covid-19 meeting on May 11th.
After careful consideration, the committee recommended that a proposed phase 2/3 clinical trial be granted permission under certain conditions.
The proposal had previously been discussed at the February 24 SEC meeting and the company was asked to submit a revised clinical trial protocol.
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