India’s apex drug regulator The Drugs Controller General of India on Thursday granted permission to Bharat Biotech for conducting phase two and three clinical trials of Covaxin in the age group of 2 to 18 years. The vaccine will become the first to be tested on children in the country.
The Ministry of Health and Family Welfare stated that the vaccine trial will be conducted on 525 healthy volunteers. In the trial process, the vaccine will be given by intramuscular route in two doses on day 0 and day 28.
The Centre said that the Subject Expert Committee on Tuesday discussed Hyderabad based Bharat Biotech’s proposal to conduct clinical trials of Covaxin on children.
The committee, after detailed deliberation had put forth a condition that Bharat Biotech should submit the interim safety data of phase 2 clinical trial and recommendations of the Data and Safety Monitoring Board to the Central Drugs Standard Control Organisation prior to proceeding in phase three of a clinical trial.
The Drug Controller General of India (DCGI), post all examinations, has accepted the recommendation of the Subject Expert Committee (SEC) and accorded permission for the II/III clinical Covaxin trial.
According to data by the Union Health Ministry, nearly 80,000 children had tested positive for Covid-19 between March 1 and April 4. These children were majorly from Maharashtra, Uttar Pradesh, Chhattisgarh, Karnataka and Delhi. Out of the total infected, more than 60,000 children got infected in Maharashtra in just a month.
According to an interim analysis, Covaxin had shown an overall efficacy of 78% in April against the coronavirus in adults, slightly lower than the 81% efficacy as reported in March. However, the trial data has not been released yet.
The vaccine, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, has been granted emergency use authorisation along with SII’s Covishield for India’s nationwide vaccination programme that commenced on January 16.
In the last 24 hours, India registered a total number of 3,62,727 fresh coronavirus cases. With this addition, the infection tally has risen to 2,37,03,665. The country’s death toll rose to 2,58,317 as it reported 4,120 casualties on Thursday.