New Delhi: Days after the Serum Institute of India (SII) authorities applied for permission from the Drug Controller and General of India (DCGI) to conduct a clinical trial of the Covovax vaccine among paediatric population, an expert panel recommended against it. The SII had sought permission to conduct the phase 2/3 trial of the Indian version of US-based Novavax Inc-developed vaccine named Covovax on children aged two to 17 years, sources said. The SII wanted to conduct the trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country,” a source said.
“It also recommended that the Pune-based company should submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children,” the source said.
The recommendations are learnt to have been approved by the DCGI. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in low and middle-income countries and India.
The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults. In January, the SII had rolled out the Covishield vaccine in the country. It had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
(With Agency inputs)
source https://www.india.com/news/india/govt-panel-says-no-to-serum-institutes-covovax-trial-on-children-aged-2-17-years-4780293/
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