SII now aims to include kids aged 2 to 6 in vaccination trials in a month
The Serum Institute of India has expanded Covovax’s paediatric trial in seven to 11 years age bracket across 10 sites in India, including Pune, after ensuring vaccine safety in adolescents. The Covishield maker aims to scale the paediatric trial further by including kids in the two to six years age-bracket in the trial’s immediate next phase.
The phase 2 and 3 paediatric trials of Covovax that kicked off in August would have a total of 920 children — 460 in 12 to 17 years, 230 in 7 to 11 years and another 230 in 2 to 6 years age groups.
“According to the trial design, we expand the trial after ensuring the vaccine safety in 100 children from each group in the reverse order of age. We aim to include kids in the 2-6 years age bracket within a month, once the vaccine safety is confirmed in 100 kids in the 7 to 11 years age group,” said a trial investigator.
The recombinant nanoparticle protein-based vaccine — NVX-CoV2373 — developed by the American biotechnology firm Novavax has been branded Covovax in India. The Serum Institute of India (SII), partnering with Novavax, is expected to launch Covovax for adults in India by November this year and for children early next year.
Bharati Hospital and KEM Hospital’s Vadu branch in Pune are among the 10 sites where the children are undergoing advanced trials. They would be followed up for six months after being inoculated with two doses of Covovax, given 21 days apart.
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