To assess the efficacy of COVID vaccines on children, Hyderabad-based Bharat Biotech International Ltd, an Indian vaccine manufacturing company, has kick started paediatric trials of its COVID-19 vaccine Covaxin at the All India Institute of Medical Sciences (AIIMS) in Patna, Bihar, today June 3.
As per news reports, the trials are scheduled to take place in 525 children at three trial sites — AIIMS Patna, Felix Hospital in Greater Noida, and Meditrina Hospital in Nagpur.
“Vaccine trials on children are being done at AIIMS Patna. Our target is to vaccinate 525 children. RT-PCR and antigen tests are being done before the trials. Follow up is being done on regular basis,” CM Singh, Principal Investigator, COVID vaccine trial, was quoted by media.
The trial is being conducted between three age groups — 2-6 years, 6-12 years, and 12-18 years, with 175 participants each.
“The study is designed to evaluate the safety, reactogenicity & immunogenicity of 3 groups ages ≤18 – >12, ≤12 ->6, ≤ 6 – >2 years of healthy volunteers who receive 2 doses of the whole virion inactivated SARS-CoV-2 virus vaccine) 28 days apart,” the Indian Council of Medical Research (ICMR) was quoted in a news report.
Bharat Biotech’s Covaxin has been developed in collaboration with the ICMR.
The trials were started following the Drugs Controller General of India’s (DCGI) approval for the Phase II and III clinical trials of Covaxin in the age group of 2 to 18 years. The permission has been granted after “careful examination”, said the Ministry of Health and Family Welfare.
Also Read: DCGI gives nod to Phase II, III clinical trials of Covaxin for 2-18 years age group
Earlier this year, Bharat Biotech submitted the proposal of conducting trials on children. The proposal was deliberated in the meeting of the Subject Expert Committee (SEC) in February as Bharat Biotech was asked to submit a revised clinical trial protocol.
The vaccination drive in India kicked off on January 16. So far, 221,043,693 vaccine doses have been administered in the country. Over 2.2 million vaccine doses were administered yesterday June 3.
A week back on May 28, the Union Minister Prakash Javadekar announced that India will vaccinate all its eligible population by this December-end.
“Vaccination exercise in India to be complete by December. The Health Ministry gave a roadmap for producing 216 crore doses by then,” said Javadekar, adding “India is the second country conducting the fastest and largest vaccination drive worldwide.”
Also Read: India will vaccinate all by this December-end: Union Minister Prakash Javadekar
