New Delhi: On Tuesday, an expert committee recommended Bharat Biotech’s COVID-19 vaccine Covaxin for phase II/III clinical trial on those aged between two to 18 years.
The Central Drugs Standard Control Organization (CDSCO) by the Subject Expert Committee (SEC) on COVID-19 took the decision after the Hyderabad-based Bharat Biotech sought approval to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
Amid the reports that children are likely to be at uncertainty in the possible third wave of the COVID-19 virus in the country. As per the experts, the first wave of the virus hit the elderly, in the second wave more youth are hit and the third wave can be hazardous for children.
AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur are among the sites where the trial will be held in 525 subjects.
“After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of 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, PTI reported.
At first, the firm was asked to present a revised clinical trial protocol after the SEC held a meeting on February 24 to discuss the project.
Indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), Covaxin, is currently being applied to people above 18 years of age in the ongoing nationwide vaccination drive against COVID-19.
Recently, the Centre dropped a viral tweet that declared that Covaxin, has been approved for children above 12 years of age.
“A tweet has claimed that Bharat Biotech’s vaccine, Covaxin, has been approved for children above 12 years. This claim is #Fake. No such approval has been given by the Government of India,” the PIB said in a “Fact Check” alert.
The Press Information Bureau said in a tweet that currently, citizens above the age of 18 are eligible for COVID-19 vaccination.
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