The All India Institute of Medical Sciences (AIIMS) in Delhi, will start screening children aged between 12-18 years for clinical trials of India’s indigenous COVID-19 vaccine- Bharat Biotech’s Covaxin, from today, June 7, 2021.
The development comes after it received a go-ahead from the Drugs Controller General of India (DCGI) following the recommendation by the Subject Expert Committee.
AIIMS Delhi joins AIIMS Patna in the effort, which began a similar trial for children aged between 2 to 18 years on June 3rd. AIIMS, Delhi is now starting the screening for children before starting the trials.
AIIMS Patna Covaxin Trials on Children: Key Highlights
• Initially, 15 children underwent the COVID-19 screening test for the COVAXIN trials, which includes an RT-PCT test, Antibody Test and General check before receiving their vaccine shots.
• Only those children found fit for the clinical trials after the screening were given the first COVAXIN dose. The children with antibodies could not proceed with the trials.
• Roughly, 10 children have received the first dose of the indigenously developed COVID-19 vaccine so far. They will be receiving their second dose in 28 days.
• AIIMS Patna aims to give the trial dose of Covaxin to at least 100 children.
AIIMS Patna superintendent and the principal trial investigator Dr CM Singh had informed then that the Institute is commencing trials in the reverse order of age. He said that children aged between 12-18 years will be given the shots first, followed by children aged between 6-12 years before proceeding to children in the 2-6 years age group.
Dr Singh had informed before administering the vaccine to children, they conducted a real-time polymerase chain reaction (RT-PCR) test to check them for COVID-19 antibodies and test them for pre-existing diseases besides conducting a physical examination.
This is the first instance of the COVID-19 vaccine being tested on children in India. The children will be administered two Covaxin shots in a gap of 28 days during these trials.
COVAXIN is the first made-in-India vaccine against COVID-19, developed jointly by Bharat Biotech, a Hyderbad-based biotechnology firm in collaboration with the Indian Council of Medical and its subsidiary the National Institute of Virology.
• The Drugs Controller General of India (DCGI) had permitted Hyderabad-based Bharat Biotech to conduct phase 2 and 3 trials of COVAXIN on children aged 2 to 18 years on May 13, 2021.
• The Covaxin clinical trials on Children will be conducted at three sites across India – AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences Nagpur.
• Globally, the Pfizer-BioNTech COVID-19 vaccine has already been authorized for emergency use on children aged 12 years and above in the US, European Union, Singapore, Canada and the UAE. Germany will also begin vaccinating children in the age group of 12-16 years from June 7th.
• Moderna will also begin phase 2 and 3 clinical trials of its COVID-19 vaccine on infants and children in the age group 6 months to 12 years old.
• As per experts, a possible third wave could cause as much devastation as the second wave of the coronavirus pandemic if enough people are not vaccinated against the virus and that children could be the main target.