NEW DELHI: An expert panel of the country’s Central Drugs Authority on Wednesday recommended against allowing Serum Institute of India (SII) to conduct phase 2/3 trial of the Covid-19 vaccine Covovax on children aged two to 17 years, sources said.
SII on Monday applied to the Drugs Controller General of India (DCGI) seeking permission to test Kovovax at 10 sites, 920 children in the age group of 12-17 and 2-11, 460 each.
“Subject Expert Committee (seconds) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country,” a source said.
The source added, “It has also been recommended that the Pune-based company be considered for conducting a clinical trial in children with safety and immunogenicity data (of Kovovax) from the ongoing clinical trial in adults. Must submit.”
It is believed that these recommendations have been approved by the DCGI.
In August 2020, US-based vaccine maker Novavax Inc. announced a license agreement with SII to develop and commercialize NVX-CoV2373, its COVID-19 vaccine candidate, in low- and middle-income countries and India.
Clinical trials of Covovax began in India in March and SII expects to launch it for adults by September.
In January, SII had launched Cowishield The vaccine had entered the country in collaboration with University of Oxford and to make the AstraZeneca vaccine.
SII on Monday applied to the Drugs Controller General of India (DCGI) seeking permission to test Kovovax at 10 sites, 920 children in the age group of 12-17 and 2-11, 460 each.
“Subject Expert Committee (seconds) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country,” a source said.
The source added, “It has also been recommended that the Pune-based company be considered for conducting a clinical trial in children with safety and immunogenicity data (of Kovovax) from the ongoing clinical trial in adults. Must submit.”
It is believed that these recommendations have been approved by the DCGI.
In August 2020, US-based vaccine maker Novavax Inc. announced a license agreement with SII to develop and commercialize NVX-CoV2373, its COVID-19 vaccine candidate, in low- and middle-income countries and India.
Clinical trials of Covovax began in India in March and SII expects to launch it for adults by September.
In January, SII had launched Cowishield The vaccine had entered the country in collaboration with University of Oxford and to make the AstraZeneca vaccine.
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