Covaxin Phase 2, 3 Clinical Trials For 2-18 Age Group Cleared Covaxin Phase 2, 3 Clinical Trials For 2-18 Age Group Cleared Covaxin maker Bharat Biotech has said the trial will be carried out on 525 healthy volunteers .
The Covaxin trial involves two vaccine doses injected at day 0 and day 28.
Highlights
Drug regulator cleared trials after recommendation of expert committee
The Covaxin trial involves two vaccine doses injected at day 0 and day 28
New Delhi:
Covaxin trials on children from two to 18 years were cleared by the Drugs Controller General of India (DCGI) today. This is the first time in India that a Covid vaccine will be tested on children.
3:36 PM
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.
India Covid: Regulator nod for Phase 2, 3 clinical trials of Covaxin on 2-18-year-olds
Web Report/New Delhi
The trial involves two doses injected on days 0 and 28.
The Drugs Controller General of India (DCGI) on Thursday cleared Covaxin trials on those between two and 18 years, the first time such vaccines will be tested on children.
The DGCI accepted the recommendations of an expert committee on vaccines. The trial involves two doses injected on days 0 and 28 and will take place at the All India Institutes of Medical Science in Delhi and Patna and Meditrina Institute of Medical Sciences, Nagpur, among others.
Bharat Biotech along with the Indian Council of Medical Research and the National Institute of Virology is only Indian Covid shot maker. The company said its second and third phase trials will be done on 525 healthy volunteers.