NEW DELHI: India’s apex drug regulator has turned down a proposal by Serum Institute of India to test the Covid-19 vaccine Covovax on children, saying it needs to evaluate safety and immunogenicity data from the ongoing bridging trial in adults.
Covovox is the Indian version of the vaccine by the US-based Novavax, which had shown an efficacy of over 90% in Phase III clinical trials, the company claimed in a statement last month. It is yet to be approved by the US FDA.
The SII had applied to the Central Drugs Standard Control Organisation earlier this week, seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, across 10 sites.
The Pune-based vaccine maker had said last month that it hopes to start clinical trials of this on children by July and introduce the vaccine for adults in India by September. This vaccine is being tested for safety and immunogenicity in nearly 1600 adults in the country. The firm has already started producing its first batches ahead of its commercial launch in India.
The timeline to conduct the trial on children, however, may be pushed back with the latest development. Incidentally, senior authorities in the government were also keen for this trial to begin in children. “As you know, they (Serum Institute) are conducting a bridging trial already, which is in advanced stages of completion...
We hope they will complete the trial on schedule, and also hope they will start, in good time, trials in children,” V K Paul, member (health) of Niti Ayog and chairman of the National Expert Group on Vaccine Administration for Covid-19.
He had added that it was time to start the trial in the paediatric population without delay. In the country, Covaxin by Bharat Biotech has so far been the only vaccine allowed to be tested on children and adolescents aged 2-17, while the coronavirus vaccine by Zydus Cadila has already carried out safety and immunogenicity studies on a hundred 12-17-year-olds.
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