Covaxin clinical trials on 6-12-year-olds, AIIMS to start screening

New Delhi: On Tuesday, the All India Institute of Medical Sciences (AIIMS), New Delhi will start screening children in the age group of 6-12 years for the clinical trials of Bharat Biotech’s Covaxin. ‘The selection process for the clinical trial of Covaxin among children in the age group of 6-12 years will begin from Tuesday,’ Dr. Sanjay Rai, professor at the Centre for Community Medicine at AIIMS Delhi, told the news agency on Monday.

The selection for clinical trials in the 12-18 years is already over, and children within this age group have been served with a single dose of the vaccine. After the recruitment of children from 6-12 years is done, AIIMS New Delhi will begin trials for children between 2 and 6 years.

Dr. Prabhat Kumar Singh, director of AIIMS Patna said, ‘After these trials, the age group will be 6-12 years and then 2-6 years but now we have started trials in the age group of 12-18 years.’ He also said that during the last week 54 children had enrolled for the trials of which 16 belonged to the 12-18 years age group.

The Drugs Controller General of India (DCGI), on May 12,  granted approval to conduct the second and the third phase of the clinical trial of Covaxin among children in 2-18 years group. As per the media report, on Monday the trial will be conducted in three parts, having 175 volunteers each in 12-18 years, 6-12 years and 2-6 years age groups.

The vaccine will be given by the intramuscular route in two doses on day 0 and on day 28. The trial will evaluate the safety, reactogenicity and immunogenicity of the vaccine in children, the media further reported. The decision to launch a mass vaccination drive for children comes after the Centre warned that even though the coronavirus disease (Covid-19) has not had a serious shape among them, the force of the viral disease can increase if there is a change in virus behavior or epidemiology dynamics.

India has so far vaccinated 25,48,49,301 beneficiaries against the coronavirus disease (Covid-19), till now of which nearly 1.5 million beneficiaries were vaccinated in the last 24 hours. On Monday, the country saw 70,421 new cases, which drove the caseload to 29,510,410. Monday’s case count has been the lowest since April 1, when 72,330 were recognized as Covid-19 positive.