Bharat Biotech was granted permission by India’s Drugs Controller General on Thursday to perform phase two and three clinical trials of its coronavirus vaccine Covaxin on children aged two to eighteen years. The vaccine will be the first in the world to be tested on infants.
According to the Ministry of Health and Family Welfare, the trial will include 525 balanced volunteers. The Covaxin will be administered intramuscularly in two doses on days 0 and 28 of the trial.
The Subject Expert Committee addressed Bharat Biotech’s proposal to perform clinical trials of its vaccine on children on Tuesday, according to the Centre.
The committee had demanded that Bharat Biotech send interim safety data from the phase 2 clinical trial, as well as the Data and Safety Monitoring Board’s recommendations, to the Central Drugs Standard Control Organisation before moving on to phase three, according to PTI, citing an unnamed official.
In the second phase of the pandemic, more children are contracting the coronavirus.
According to data from the Union health ministry, nearly 80,000 children from Maharashtra, Chhattisgarh, Uttar Pradesh, Karnataka, and Delhi tested positive for the virus between March 1 and April 4. In Maharashtra, more than 60,000 children were infected in just one month.
According to an interim review of Covaxin’s third phase of clinical trials released in April, the drug had a 78 percent overall efficacy against the coronavirus in adults. This was marginally lower than the company’s March report of 81 percent efficacy. However, the trial results are yet to be made public.
The vaccine, developed by Bharat Biotech and the Indian Council of Medical Research, was given emergency use authorization, along with Covishield from the Serum Institute of India, ahead of India’s nationwide vaccination program, which began on January 16.
On Thursday, India reported 3,62,727 new coronavirus cases, bringing the total number of infections to 2,37,03,665 since the pandemic began in January of last year. The death toll in the country has risen to 2,58,317, with 4,120 deaths recorded in the last day.
Several states are experiencing vaccine shortages as a result of the large increase in cases. Maharashtra and Karnataka announced on Wednesday that vaccination for those aged 18 to 44 will be temporarily halted.