The vaccine expert panel denied permission to Serum Institute of India (SII) to conduct clinical trials on children for Novavax, on Thursday. In addition, it felt there was no need to conduct a separate Indian clinical trial of Sputnik Light, as adequate safety and immunogenicity data is already available.
The decision comes as a setback to SII, which had sought permission to start a pediatric clinical trial of Covovax. The Subject Expert Committee’s (SEC) decision means DRL does not require separate safety and immunogenicity trials on Indians for getting approval for Sputnik Light. As for SII, the permission was denied as