The recruitment for the clinical trial of the country’s first indigenously-developed Covid vaccine –– Covaxin, among children falling in the age group of 6-12 years has begun at the All India Institute of Medical Sciences (AIIMS), Delhi. This will be followed by the clinical trial of 2-6 years’ children. The enrolment of children volunteers aged 12-18 years at the AIIMS has been completed and they have already been given the first dose of Covaxin.
The Drugs Controller General of India (DCGI) had granted permission for conducting the phase 2/3 clinical trial of Bharat Biotech’s Covaxin among children aged two to 18 years on May 12. The trial is to be conducted in three parts — 175 volunteers each in the groups aged 12-18, 6-12 and 2-6 years.
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28. The clinical trials will evaluate the safety, reactogenicity and immunogenicity of the vaccine in children.
The government recently cautioned that even though COVID-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in the virus behaviour or epidemiology dynamics and said preparations are being strengthened to deal with any such situation.
A national expert group has been formed to review COVID-19 cases in children and approach the pandemic in a renewed way to strengthen the country’s preparedness, NITI Aayog Member (Health) V K Paul had told a press conference.