The Drugs Controller General of India on Thursday gave permission to Bharat Biotech to conduct phase two and three clinical trials of its coronavirus vaccine Covaxin on children in the age group of two to 18 years. The vaccine will be the first to be tested on children in the country.
“The trial will be conducted in 525 healthy volunteers,” the Ministry of Health and Family Welfare said. “In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.”
The Centre said that the Subject Expert Committee on Tuesday discussed Bharat Biotech’s proposal to conduct clinical trials of its vaccine on children.
The committee had put forth a condition that Bharat Biotech 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 before proceeding to phase three, PTI had reported on Tuesday, quoting an unidentified official.
More children are contracting the coronavirus in the second phase of the pandemic.
Nearly 80,000 children from Maharashtra, Chhattisgarh, Uttar Pradesh, Karnataka and Delhi had tested positive for the virus between March 1 and April 4, according to data by the Union health ministry. Out of these, more than 60,000 children were infected in Maharashtra in just a month.
Covaxin had shown an overall efficacy of 78% against the coronavirus in adults, according to an interim analysis of its third phase of clinical trials in April. This was slightly lower than the 81% efficacy reported by the company in March. However, the trial data has not been released yet.
The vaccine, developed by Bharat Biotech and the Indian Council of Medical Research, had been granted emergency use authorisation along with Serum Institute of India’s Covishield ahead of India’s countrywide vaccination programme that started on January 16.
India on Thursday registered 3,62,727 new coronavirus cases, taking the infection tally to 2,37,03,665 since the pandemic broke out in January last year. The country’s toll rose to 2,58,317 as it reported 4,120 deaths the last day.
Amid the massive surge in cases, several states are grappling with shortages of vaccine doses. On Wednesday, Maharashtra and Karnataka said they were temporarily suspending vaccination for those in the 18-44 age group.