Vaccine major Serum Institute of India (SII) is all set to start phase 2 and 3 paediatric trials of Covovax on 920 children — 460 each in the 12-17 and 2-11 age groups — from next month.
The recombinant nanoparticle protein-based vaccine —NVX-CoV2373 — developed by American biotechnology firm Novavax has been branded as Covovax in India. It will be the fourth Covid-19 vaccine to undergo clinical trials for children in India.
SII, partnering with Novavax, expects to launch Covovax for adults in India by September and for children by the end of this year.
“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’s owner and chief executive officer Adar Poonawalla said.
Bharati Hospital and KEM Hospital’s Vadu branch in Pune are among the10 sites where the children will undergo advanced trials. They would be followed up for six months after inoculating with two doses of Covovax, given 21 days apart.
According to the trial design, enrolment of children in the 12-17 age group would be done first, followed by the 2-11 age group, Poonawalla said. “We shall commence the trials in the reverse order of age. Children in the 12-17 age group will be given the shots first and later the 2-11 age group,” he said.
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