Bharat Biotech’s Covaxin Gets Nod For Phase 2/3 Trials On 2-18-Yr-Olds: Report
Mumbai: The Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee has reportedly given its nod to Bharat Biotech’s Covaxin for Phase 2 and 3 trials on children aged between two and 18 years.
Subject Expert Committee (SEC) decision on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) took the decision after the Hyderabad-based Bharat Biotech sought 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.
According to the report, a possible third wave of COVID-19 virus in the country could put children at risk. According to experts, the first wave of the virus attacked the elderly, the second wave affected more youth, and the third wave could be dangerous for children.
PTI quoted sources as saying that the test will take place in 525 subjects at various sites including AIIMS in Delhi, AIIMS in Patna and Meditrina Institute of Medical Sciences in Nagpur.
“After detailed deliberations, the committee recommends that the firm conduct a Phase II / III clinical trial of a fully inactivated coronavirus vaccine in the age group of 2 to 18 years of age. The trial should 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, PTI reported.
Earlier, the firm held a meeting on 24 February to discuss the proposal, asking the firm to submit a revised clinical trial protocol.
Indigenously developed Covaxin is currently being provided by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) to people over the age of 18 in an ongoing nationwide vaccination campaign against COVID-19.
(With PTI Inputs)
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