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.
NEW DELHI: 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.
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Highlights
Bharat Biotech s Covaxin has got approval for phase 2/3 trials on 2-18 year-olds
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
New Delhi: The Hyderabad-based Bharat Biotech s COVID-19 vaccine Covaxin has got the necessary approval from an expert panel for conducting phase 2/3 trials on those aged between 2 to 18 years.
According to news agency PTI, the drug maker’s
anti-COVID vaccine was recommended by an expert panel (Subject Expert Committee) for phase II/III clinical trial on those aged between two to 18 years on Tuesday.
Official sources said that the trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.