The Serum Institute had applied to the DCGI on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites
An expert panel of India’s central drug authority has recommended against granting permission to the Serum Institute of India (SII) for conducting phase 2/3 trial of Novavax’s Covid-19 vaccine ‘Covovax’ on children, reported news agency PTI quoting sources.
As per the report, the Subject Expert Committee (SEC) has stated that the vaccine has not been approved in any country.
“The 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 was quoted as saying.
“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,” they added.
The recommendations are learnt to have been approved by the DCGI.
The SII had applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
The SII had said earlier last month that it hopes to start clinical trials of Covovax on children by July and introduce the vaccine for adults in India by September.
The central government was also keen on the Pune-based vaccine manufacturer starting a trial, NITI Aayog member health Dr VK Paul had said.
“As you know, they (Serum Institute) are conducting a bridging trial already, which is in advanced stages of completion… We hope they will complete the trial on schedule, and also hoping that they would also start in good time trials in children,” Paul said.
He added that it is time to start the trial in the paediatric population without delay.
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.
Novavax in June reported an efficacy of 90.4% in the interim analysis from its phase 3 trial on 29,960 participants in the US and Mexico.
It also showed that the vaccine had an efficacy of 100% in preventing people from getting moderate and severe diseases.
The vaccine is based on a recombinant protein technology, also used in the candidate developed by Sanofi and GlaxoSmithKline Plc.
Serum Institute of India started “at-risk” production of the vaccine in small quantities last month. The production is “at-risk” because of the significant financial risk taken by the company.(mint)
