Civic-run BYL Nair Hospital, which is conducting clinical paediatric trials for Covovax vaccine is having issues finding eligible volunteers for the purpose. With most children having developed antibodies against the SARS-CoV-2 virus, only six children have participated in the process, since it began in the second week of October.
According the dean of the hospital, Dr Ramesh Bharmal, it was found that children had high exposure levels to SARS-CoV-2 virus, as was also evident from the previous serosurvey of Mumbai kids, which had shown that 50 per cent of them had antibodies to the virus. So, while the hospital is getting volunteers, those testing positive for antibodies have to be turned away and this is slowing down the trial.
“We are looking for participants who have not developed antibodies. We had a similar problem when the clinical trial of Zydus Cadila’s DNA-based, needle-free Covid vaccine was started; only 12 volunteers were eligible. Nonetheless, we are not losing hope and will keep going with the trial,” he said.
The paediatric trials for 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.
Covovax, which will also be manufactured by Pune-based Serum Institute of India, has shown the vaccine has 90 per cent efficacy in other trials. Every child enrolled in the trial will be given two shots, 21 days apart. “Their antibody levels will be studied multiple times, beginning with the first day of vaccination, then on days 22, 36 and 180,” said Dr Bharmal. “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.
Meanwhile, health experts believe the hospital and government should rope in doctors from the Indian Academy of Paediatrics (IAPs), who have been treating children during the ongoing pandemic, for assitance. They could create awareness related to the clinical trial and help draw more volunteers.
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 the ongoing advanced trials. Their health will be monitored for six months after inoculation with two doses of Covovax, to be administered with an interval of 21 days.
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.
