In a bid to scale the paediatric trial, 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. The was done after ensuring vaccine safety in adolescents.
In the near future, SII also aims to scale the paediatric trial further by including kids in the two to six years age bracket in the trial’s next phase.
Explaining the workings of the trial phase, a trial investigator told TOI that the trial is expanded after ensuring the vaccine safety in 100 children from each group in the reverse order of age. 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.
According to reports, 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.
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SII will be submitting the interim trial findings on immunogenicity after three months of the advanced clinical trial for licensure.
The phase 2 and 3 paediatric trials of Covovax that kicked-started in August is set to 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.
Experts contended that with Children comprising about 13 to 14 crore of the population, India would need about 25-26 crore doses for them.
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