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An expert panel on Tuesday recommended Bharat Biotech’s COVID-19 vaccine Covaxin for phase II/III clinical trials on children aged two to eighteen years, according to official sources. The trial will include 525 subjects and will take place at various locations, including AIIMS in Delhi, AIIMS in Patna, and Meditrina Institute of Medical Sciences in Nagpur.
The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee (SEC) on COVID-19 met on Tuesday to discuss Hyderabad-based Bharat Biotech’s application for 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.
Covaxin Receives Nod For Trials On Children Between 2-18 Age Group
The trial involves two vaccine doses injected on day 0 and day 28.
Outlook Web Bureau 13 May 2021, Last Updated at 11:54 am File photo Outlook Web Bureau 2021-05-13T11:14:09+05:30 Covaxin Receives Nod For Trials On Children Between 2-18 Age Group outlookindia.com 2021-05-13T11:54:09+05:30
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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.
Highlights
Bharat Biotech to set up a new plant of Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) in Uttar Pradesh’s Bulandshahr.
This new PSU will manufacture 2 crore doses of Covaxin every month.
The central government will provide Rs 30 crore to BIBCOL for this project.
Lucknow: As states face an acute shortage of COVID-19 vaccines, the central government on Wednesday (May 12, 2021) approved the proposal of Bharat Biotech to set up a new plant of Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) in Uttar Pradesh’s Bulandshahr.
As per News18 reports this new PSU will manufacture 2 crore doses of Covaxin every month and the central government will provide Rs 30 crore to BIBCOL for this project.
Covaxin recommended for phase 2-3 trials on those aged between 2-18 years
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur
PTI | May 12, 2021 | Updated 08:14 IST
Bharat Biotech s COVID-19 vaccine Covaxin was on Tuesday recommended by an expert panel for phase II/III clinical trial on those aged between two to 18 years, official sources said.
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.
Bharat Biotech s Covaxin recommended by expert panel for phase 2/3 trials on children
Bharat Biotech’s Covaxin shot has been recommended by the expert panel on Covid-19 for further trials on children aged between 2 and 18 years, said sources.
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Health minister Harsh Vardhan with a Covaxin vial. (Reuters)
Bharat Biotech’s Covaxin shot has been recommended by the expert panel on Covid-19 for further trials on children aged between 2 and 18 years, said sources.
The Subject Expert Committee (SEC) on Covid-19 has recommended that Bharat Biotech be granted permission to conduct the phase 2/3 clinical trials of Covaxin, on children in the 2-18 age group.