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.
India’s indigenous Covid-19 vaccine, approved for phase 2/3 clinical trial on children
India’s Covid-19 vaccine COVAXIN has been developed by Bharat Biotech and a state research institute. File photo Star Digital Report Star Digital Report
India s indigenous Covid-19 vaccine, Covaxin, manufactured by Bharat Biotech, has been approved by the government s panel of experts for phase 2/3 clinical trial on children aged 2-18, official sources said today.
The trial will take place on 525 participants at various sites across India, including New Delhi, Patna and Nagpur, our New Delhi correspondent reports.
The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday is understood to have given the approval after deliberating on Hyderabad-based Bharat Biotech s application seeking permission to conduct phase 2/3 clinical trials to evaluate the safety, reactogenicity and immunogenicit
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.
Experts Recommend Bharat Biotech’s Covaxin 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.
Outlook Web Bureau 12 May 2021, Last Updated at 10:51 am PTI Outlook Web Bureau 2021-05-12T07:48:31+05:30 Experts Recommend Bharat Biotech’s Covaxin For Phase 2/3 Trials On 2-18-Year-Olds outlookindia.com 2021-05-12T10:51:25+05:30
Also read
An expert panel on Tuesday recommended Bharat Biotech’s Covid-19 vaccine Covaxin for phase II/III clinical trial on those aged between two to 18 years, official sources said.
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 im
Synopsis
On Tuesday, the Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated upon Hyderabad-based Bharat Biotech s application seeking permission to conduct the clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin among children.
AFP
The trial is expected to be conducted on 525 subjects at various sites, including AIIMS-Delhi, AIIMS-Patna.
The Subject Expert Committee (SEC) under India’s drug regulator has given its nod to Bharat Biotech for conducting phase 2 and 3 clinical trials of its Covid-19 vaccine Covaxin on children aged between 2 to 18-year-old, a senior official told ET.
The trial is expected to be conducted on 525 subjects at various sites, including AIIMS-Delhi, AIIMS-Patna.