In a setback for the Serum Institute of India (SII), a panel of experts of the country’s top drug regulator has recommended against granting permission to the Pune-based vaccine major to conduct the phase 2/3 trial of Covid vaccine Covovax on children aged two to 17 years. Instead, it has asked SII to conduct the trial on the adults first.
Sources said that the SII had applied to the Drugs Controller General of India (DCGI) on June 28 seeking permission for conducting a full trial of Covovax on 920 children, 460 of them being 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,” said sources in the Union Health Ministry.
“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.
Earlier, the Centre had said that recently declared Novavax Covid vaccine efficacy data in a large trial are promising and that clinical trials are being conducted and are in an advanced stage of completion in India.
“What we’re learning from data available in the public domain that this vaccine is very safe and highly effective. It’ll be produced in India,” Dr VK Paul, Member-Health, Niti Aayog had said a few days ago in a routine briefing by the Union Health Ministry on the Covid-19 situation in India.
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.