Vaccine major Serum Institute of India (SII) is set to start Phase 2 and 3 pediatric trials of Kovovax on 920 children from next month. The recombinant nanoparticle protein-based vaccine-NVX-CoV2373, developed by American biotechnology firm Novavax, has been branded as Covovax in India. This will be the fourth COVID-19 vaccine to undergo clinical trials for children in India. SII, in partnership with Novavax, hopes to launch Covovax for adults in India by September and Covovax for children by the end of this year. According to the latest guidelines by the Drug Controller General of India (DCGI), the company can apply for the license of the vaccine before the completion of the trial, based on global trial results. The primary objective of the study is to assess the safety and immunogenicity of the vaccine in children. Healthy volunteers will be given two doses of Kovovax spaced 21 days apart. Seven days after the first dose for 25 participants (aged 12-17), safety data will be reviewed by the Data Safety Monitoring Board (DSMB). Based on its recommendation, the study will proceed by recruiting the remaining participants. The same process will be repeated for the age group 2-11.
