In a first, 16-year-old girl enrolled for Covid-19 vaccine trial
A 16-year-old girl became the first child in Karnataka to enroll in a Covid-19 vaccine clinical trial.
Jeevan Rekha Hospital in Belagavi started Phase 3 clinical trials of Zydus Cadila's Covid vaccine ZyCoV-D on February 1, in which 500 people have already enrolled and received the first dose, including this paediatric volunteer.
Currently, no Covid-19 vaccines are available for children. Worldwide, there are, but a few trials that have enrolled children in clinical trials. In the US, Pfizer-BioNTech and Moderna recently started trials of their vaccines among children aged above 12.
In Karnataka, 27,434 children in the 0-9 year age group had contracted Covid-19; 28 of them died. In the 10-19 year age group, 63,708 children were infected, out of whom 45 died. Some infected children had developed the multi-system inflammatory syndrome.
Even in the Covishield and Covaxin trials in the state, no child was enrolled.
The hospital has already vaccinated 175 in its Phase 2 trial. It was not a part of Phase 1. The trial is allowed to enrol children between the ages of 12 and 18 years.
The teenager was enrolled after an audiovisual consent from her and her parents in the presence of the principal investigator. She has reported no major side-effects so far.
Dr Amit Bhate, director, Jeevan Rekha Hospital, Belagavi, also the principal investigator of the clinical trial, told DH, "We had received two or three enquiries from parents of children. One girl has been vaccinated so far with the first dose. The parents have to maintain a 'diary card' where they have to note down any reaction developed post-vaccination for 56 days and submit it after receiving three doses."
The vaccine has to be administered via the intradermal route in the upper arm (unlike Covishield and Covaxin that are given via intramuscular route) on day 0, 28, and 56. "In case of female children, the mother has to be compulsorily there with the child, where everything about the vaccine is explained to both," he said.
There are 43 trial sites across the country and Jeevan Rekha Hospital is the only trial site for this vaccine in the state. The sample size is 28,216.
"All the 175 vaccinated in Phase 2 trial with three doses at our hospital are doing fine without any major side-effects. We are still observing them. This will go on for eight months," he said.
They come in for blood sampling to check their antibody levels. "We are constantly in touch with them. As many as 2,250 volunteers were inoculated as part of the Covaxin trial at our hospital over a month. Now their friends, relatives and colleagues are coming for the ZyCoV-D trial," he said.