COVID-19: Covaxin Gets Approval for Phase 2, 3 Trials on Children Aged 2-18 Years
Updated On Jul 08, 2021
At a time when India is dealing with an unsparing second wave of COVID-19, experts have claimed that the third wave of the deadly virus will hit children this time. In an effort to protect children against the wrath of the pandemic, The Subject Expert Committee (SEC) has given approval to Bharat Biotech to start the next phase of Covaxin’s Phase II, III clinical trials on children between the age group of 2 to 18 years.
It must be noted that the expert panel had recommended Bharat Biotech's COVID-19 vaccine 'Covaxin' for phase 2 and 3 clinical trials on children on Tuesday. The SEC deliberated upon Bharat Biotech’s application seeking permission to perform phase II/III clinical trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin jabs in children belonging to the age group of 2 to 18 years. According to the reports, after a detailed discussion, it was observed that Bharat Biotech should be given the approval for trials of whole virion inactivated coronavirus vaccine.
Bharat Biotech is expected to submit the interim safety data of phase II clinical trial, in addition to Data and Safety Monitoring Boards (DSMB) recommendations to the Central Drugs Standard Control Organisation (CDSCO) before moving onto the phase III part of the study.
Reports suggest that the clinical trial will be conducted in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
As of now, Covaxin, India’s first indigenous COVID-19 vaccine developed by Bharat Biotech, in collaboration with ICMR - National Institute of Virology (NIV), is being administered to individuals above 18 years of age.
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Disclaimer: This article is issued in the general public interest and meant for general information purposes only. Readers are advised not to rely on the contents of the article as conclusive in nature and should research further or consult an expert in this regard.
