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Bharat Biotech s Covaxin recommended by expert panel for phase 2/3 trials on 2-18 year-olds
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.
Express News Service
NEW DELHI: As India faces an avalanche of Covid cases, the expert panel of the apex drug regulator on Monday recommended the use of Russia’s Covid vaccine Sputnik V in the country’s vaccination drive.
This approval comes amidst the clamour to approve other Covid vaccines in India irrespective of their bridging trial status in the country.
The authorities too concede that while bridging trial data from the country is required to authorize the use of any vaccines in the country under the existing norms, it may be exempted under the present clinical trial norms.
Sputnik V, based on human adenoviral vectors, is one of only three vaccines in the world, along with those by Pfizer and Moderna, with an efficacy of over 90%.
The Asia-Pacific Region: A Hot Spot For Clinical Trials
By Mathini Ilancheran, principal analyst, R&D, Beroe Inc.
Introduction
The Asia-Pacific region has become the hot spot for conducting clinical trials due to the ease of regulatory compliance, the low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites. For example, the regulatory agencies in China are working toward an enhanced clinical trial process by reducing the overall review and approval process.
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The clinical trial workforce contributes to around 30 to 35% of the overall trial cost. This makes FTE rates for clinical research a key parameter to consider. These rates are generally higher in the developed markets as compared to the Asia-Pacific region, which is why the latter is becoming an important location for conducting clinical trial studies. Also, the cost per patient across all therapeutic areas and phases is much lower in Asian countries