Paving way for the first Covid-19 inoculation to be tested on minors, India’s drug regulator has given Bharat Biotech permission to conduct clinical trials of its coronavirus vaccine, Covaxin, on children between the age of 2 and 18.
The trial involves two vaccine doses injected on day 0 and day 28.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech''s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
"After detailed deliberation, the committee recommended for the conduct of proposed phase II/III clinical trial of the whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India''s ongoing COVID-19 vaccination drive.
US regulators this week gave emergency use authorisation to Pfizer-BioNTech’s Covid-19 vaccine for children aged between 12 and 15. The vaccine was already being administrated to those above 16. Canada became the first country in the world to approve Pfizer’s Covid-19 vaccine for ages as young as 12 on May 5.