The Drugs Controller General of India (DCGI) has today given its nod to Hyderabased-based Bharat Biotech International Ltd, a vaccine manufacturing company, to conduct Phase II/III clinical trials of its COVID19 vaccine — Covaxin — in the age group of 2 to 18 years. The organisation is responsible for approval of licences of specified categories of drugs and vaccines in the country.
The permission has been granted after “careful examination”, the Ministry of Health and Family Welfare said in a statement. “The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021,” the statement read.
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Bharat Biotech will conduct the trial on 525 healthy volunteers between two and 18 years of age. In the trial, the vaccine will be administered by the intramuscular route in two doses given at day zero and day 28.
As a rapid regulatory response, the proposal was deliberated in the SEC on May 11. The committee after detailed deliberation recommended for the grant of permission to conduct a proposed Phase II/III clinical trial to certain conditions.
Earlier this year, Bharat Biotech submitted the proposal of conducting trials on children. The proposal was deliberated in the meeting of the SEC in February as Bharat Biotech was asked to submit a revised clinical trial protocol.
On April 24, Bharat Biotech had said the Phase III study of Covaxin showed 78 per cent overall efficacy against COVID-19 and 100 per cent overall efficacy against severe disease and hospitalisation.
On May 1, India allowed the vaccination for everyone between the age group of 18 and 44 years. But a need to extend vaccination to those below 18 years was being felt. Delhi Chief Minister Arvind Kejriwal has been insisting on developing vaccines for children below 18 years of age, if current ones are not recommended for them.
Experts have been warning of the third wave of COVID19, which, they say, is likely to affect kids hard. Maharashtra government has already formed a paediatric task force that will be responsible for procuring medicines for children, paediatric ventilators and building Covid-19 care centres for kids.
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Meanwhile, because of vaccine shortage, both Karnataka and Maharashtra governments have decided to temporarily suspend vaccination to people between 18 and 44 years of age.
