In a setback to Serum Institute of India (SII), the Centre's Subject Expert Committee (SEC) has recommended against granting the nod for phase 2/3 trials of Covovax for children aged 2-17, reported sources on Wednesday.
SII had applied to DCGI 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.
SII is hoping to launch 'Covovax' in India by September as its trials are in an advanced stage of completion and manufacturing has commenced in Pune.
"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," a source said.
"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," it added.
The recommendations are learnt to have been approved by the DCGI.