From next month, Serum Institute of India (SII) plans to begin phase 2 and 3 paediatric trials of Covovax on 920 children — 460 each in the 12-17 and 2-11 age groups.
The Serum Institute of India (SII) will apply for permission from the Drug Controller and General of India (DCGI) to conduct a clinical trial of Covovax- an Indian version of US-based Novavax Inc-developed on children. It will be the fourth Covid-19 vaccine to go through clinical trials in India, this time for children.
“We plan to begin the paediatric trials in 920 children across 10 sites next month after seeking permission from the DCGI (Drug Controller General of India),” SII CEO Adar Poonawalla told TOI.
“A new milestone has been reached. This week we began our first batch of Covovax (a Covid-19 vaccine developed by Novavax). Excited to witness the first batch of Covovax being manufactured at our facility in Pune,” Adar Poonawalla, CEO of SII, tweeted on Friday. He added that the vaccine has great potential to protect our future generations below the age of 18 and Trials are ongoing.
SII authorities told The Indian Express that initially, they would apply for approval to conduct clinical trials of the Covovax vaccine in the 12-18 age group and then in the age group below 12 years.
SII is currently supplying and manufacturing the Covishield vaccine in technical collaboration with AstraZeneca and Oxford University. SII along with the Indian Council of Medical Research (ICMR) had planned the Phase-2/3 observer-blind randomised controlled study to determine the safety and immunogenicity of Covovax (SARS-CoV2 recombinant spike protein nanoparticle vaccine (SARS-CoV2rS) with Matrix-M1 adjuvant in Indian adults.
Poonawalla had also earlier tweeted that they hoped to launch Covovax by September this year. In September 2020, Novavax announced a manufacturing agreement with SII for its COVID-19 vaccine NVX-CoV2373. CNBC-TV18 reported. According to Poonawalla, the trial of Novavax’s coronavirus vaccine in India is likely to conclude by November. The pharmaceutical giant can apply for a vaccine license even before its trial in the country concludes on the basis of the global data of the trial, he had added.