Mumbai: The civic-run BYL Nair Hospital has started clinical trials of Covovax vaccine on children aged between two and 18 years. Covovax is the second Covid vaccine being made by Serum Institute of India (SII). Earlier, the hospital had been conducting clinical trials of ZyCov-D on children aged 12 to 18 years, which had to be stopped as it did not receive participants. So far, Covovax has shown 100 per cent protection against moderate to severe impact of the virus and an overall efficacy of 90.4 per cent efficacy in the Phase 3 trial. The SII aims to scale up the paediatric trial further by including kids in the two to six years’ age bracket in the next phase. The paediatric trials of Covovax will have a total of 920 children, 460 of whom will be 12 to 17 years of age and 460 will be aged two to 11 years. All participants will be given two doses and will be monitored for the next six months.
Dr Ramesh Bharmal, Dean, BYL Nair Hospital and medical director of civic-run hospitals, said that at present, a trial had been started on three children, one of whom had been given a placebo, while the other two had received 0.5ml each, of the first dose. The second dose will be administered to these children in 21 days. Their health will be monitored for six months. “We are expecting more participants to come forward, considering vaccines for children will be rolled out in December. We will also be checking the antibodies of the participants on the 21st, 36the and 180th days. So far, this vaccine has been tested on 30,000 in the world. Trials of this vaccine have been done in Australia, the UK, South Africa and America,” he said.
The recombinant nanoparticle protein-based vaccine — NVX-CoV2373 — developed by the American biotechnology firm Novavax, has been branded Covovax in India. The SII, partnering with Novavax, is expected to launch Covovax for adults in India by November this year and for children early next year.
Dr Bharmal further said, “Willing parents can enrol their children by visiting the hospital’s paediatrics department”.
Along with Nair Hospital in Mumbai, Bharati Hospital and KEM Hospital’s Vadu branch in Pune are among the 10 sites where children are participating in ongoing advanced trials. Their health will be monitored for six months after inoculation with two doses of Covovax, given 21 days apart.
According to the latest guidelines of the DCGI, the company can apply for a licence for the vaccine before the completion of the trials, based on the global test results. Meanwhile, the SII will submit the interim trial findings on safety and immunogenicity after three months of the advanced clinical trial, for licensing.