Only 40 out of 920 minors enrolled for paediatric vaccine trial at Nair Hospital
While the trial aims to enroll a total of 920 candidates, hospital authorities said that it has been struggling to get paediatric volunteers
Mumbai The civic-run BYL Nair Hospital has enrolled 40 children in the age group of two to 17 years for the clinical trial of Covovax, a Covid-19 vaccine developed by American biotechnology firm Novavax and produced by the Serum Institute of India. While the trial aims to enroll a total of 920 candidates, hospital authorities said that it has been struggling to get paediatric volunteers.
“We started in mid-October and have managed to recruit only 40 candidates till now,” said Dr Ramesh Bharmal, dean of BYL Nair Hospital, the only site in Mumbai conducting the paediatric trial. As per the Clinical Trials Registry- India (CTRI) as many as 23 sites across the country are trying Covovax on adults as well as paediatric cohorts. “The paediatric trial has been progressing very slowly. Largely, there is reluctance among parents to enroll their children. We get many inquiries, but they don’t convert into enrollments,” said Dr Bharmal.
A seroprevalence survey carried out in Mumbai has shown that more than 50% of children had antibodies against Covid-19 infection. Children with a known history of Covid-19 or the presence of antibodies cannot be enrolled for the study. “Many candidates become ineligible because of existing antibodies,” said Dr Bharmal adding that some parents willing to enroll their children have been demanding an assurance that they will be given the real vaccine and not a placebo, which is not possible in a trial. “It’s a blind trial and even we don’t know who receives the real vaccine and who receives a placebo till we unblind it. We counsel the parents, but it’s hard to convince them,” he said.
The hospital had received a poor response for the Zydus Cadila’s Zycov-D vaccine candidate for children and had culminated it only after 12 participants. Paediatric vaccine trials have been generating poor responses across the country. Covovax trial being conducted at the PGI Chandigarh has also been struggling to get candidates.
“It’s obvious that parents are reluctant to let their children be a part of an experiment,” said paediatrician Dr Bakul Parekh, who is a member of the state’s paediatric Covid-19 task force. “Communication is therefore crucial. We need these trials to gather evidence, and to be able to cope with the Sars-CoV-2 virus in the coming days,” he said.
The state’s task force has already given a green signal to start paediatric vaccinations in a staggered manner, rolling out the initial doses for children in the age group of 12 to 17 with comorbidities and then to children in all age groups with comorbidities. “Once the vaccines are available abundantly, we can roll them out for all children, similar to the adult vaccination drive,” said Dr Parekh.