DCGI's Expert Panel Says No To Covovax Trials On Children, Asks Serum Institute To Submit Safety Data First

The subject expert committee (SEC) of the Indian drug regulator has asked Pune-based Serum Institute of India (SII) to submit the safety and immunogenicity data from the ongoing clinical trials of Novavax's Covid-19 vaccine on adults in India ahead of applying for conducting trials on children aged 2-17 years.

The SII has partnered with US-based Novavax for manufacturing and commercialisation of its Covid-19 vaccine, which has been branded in India as Covovax.

The Pune-based vaccine manufacturing giant had on Monday (28 June) sought Drug Controller General of India's (DCGI) permission for conducting trial of Covovax on 920 children, 460 each in 12-17 and 2-11 age groups.

Considering SII's application, the SEC of the Central Drugs Standard Control Organisation (CDSCO) reportedly noted that the vaccine has not been approved in any country.

"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," a source was quoted by Times of India as saying.

The recommendations by the SEC have been reportedly approved by the DCGI.

It should be noted that the SII began the clinical trials of Covovax on adults in India in March and the company expects to launch the vaccine in the country by September.