Delhi, July 01: An expert panel recommended against granting permission to Pune’s Serum Institute of India (SII) for conducting the phase 2/3 trial of Covid-19 vaccine Covovax on children aged between two to 17 years, sources said. The panel asked the pharmaceutical company to complete trials on adults first.
The SII had on Monday applied to the Drugs Controller General of India (DCGI) seeking permission to conduct a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites, news agency PTI reported.
“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,” as per the sources.
“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.
According to the report, the DCGI has approved the recommendations of the expert panel.
In August 2020, Novavax Inc. had announced a license agreement with the Serum Institute of India for the development and commercialization 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. The SII has already begun manufacturing the first batch of Covovax, said the pharmaceutical company’s CEO Adar Poonawalla last week.
The SII was also expected to begin clinical trials of the Novavax vaccine for children this month. However, the expert panel of the country’s central drug authority seems to have said no to the vaccine trials.
Meanwhile, Hyderabad-based Bharat Biotech has already started clinical trials of Covaxin for children 12 to 18 years of age. A total of 525 children are part of these trials being conducted at the All India Institute of Medical Sciences (AIIMS) in New Delhi and Patna.
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.