The All India Institute of Medical Sciences (AIIMS), Delhi will start screening for children for clinical trials of India’s first indigenously developed COVID-19 vaccine, Bharat Biotech’s Covaxin from Monday.
Earlier this week the clinical trials of children started in AIIMS Patna between the age of 12 and 18 years old. AIIMS, Delhi is now starting the screening for clinical trials before starting the trial after getting permission from the Drugs Controller General of India (DCGI). To grant the permission of trials, DCGI’s approval was followed by a recommendation on May 12 by a Subject Expert Committee (SEC).
After the screening report comes the participants would be given the vaccine and the trial is to be conducted on 525 healthy volunteers.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. “The screening of children for conducting trial of Covaxin has started. Participants would be given the vaccine after their screening reports come,” said Dr. Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS.
For conducting the phase 2/3 clinical trial of Covaxin in the age group 2 to 18 years has been granted permission by India’s drug regulator on May 12 Covaxin is being used on adults in India’s ongoing COVID-19 vaccination drive. It was warned by the government last week that even hough COVID-19 has not taken a serious shape among children till now, its impact can increase among them if there is a change in virus behaviour or epidemiology dynamics and that preparations are being strengthened to deal with any such situation.
A national expert group has been formed to review COVID-19 infections in children and approach the pandemic in a renewed way to strengthen the nation’s preparedness, NITI Aayog Member (Health) V K Paul had said at a press conference. He said, it has also considered available data, clinical profile, the country’s experience, disease dynamics, nature of the virus and the pandemic and has come up with guidelines, which will be publicly released soon.
“While we have been systematically reviewing scientific developments in this area, the group has been formed to take an updated view of the situation,” Paul said. Asked if the Pfizer vaccine, if it comes to India, will it be considered for children between the age of 12 and 15 years as being approved by the UK, Paul had said that the country has its own vaccines which are being readied for children.
“Child cohort is not a small cohort. My rough guess is that if it is between 12 to 18 years, this itself is about 13 to 14 crore population and for which we will need about 25-26 crore doses. “We cannot have some people getting and others not getting.
So we will have to take this into account when we strategise and make a decision based on how many doses of which vaccines are available. he said. He further shared that Zydus Cadila’s vaccine is already being tested in children. “So when Zydus comes for licensure, hopefully in the next two weeks, may be we have enough data to take a view on whether the vaccine can be given to children,” he said.