Hindustan Times ST (Mumbai) - Live
50 needed, but only 11 children participate in ZyCoV-D trial
MUMBAI: Even after a month of starting clinical trials of the indigenous ZyCoV-D vaccine among children at the civic-run BYL Nair Hospital, the response of young volunteers remains lukewarm. Although the trial needs 50 children between the age of 12 and 17 years, the hospital has received only 11 volunteers so far.
The Drug Controller General on Friday granted emergency approval to ZyCoV-D, a Covid-19 vaccine developed by Ahmedabad-based Zydus Cadila, and it will be administered to people aged 12 years and above. This makes it the first vaccine in India that can be administered to adults as well as children aged above 12.
In the second week of July, Nair hospital became the first hospital in Mumbai to start clinical trials of the vaccine among children. As per officials, initially they received over 40 queries from parents who wanted to enrol their children for trial. However, eventually they all backed out. So far, only 11 children have taken the first shot of the vaccine under the clinical trial.
“We have placed advertisements about the clinical trial to encourage people to enrol their children for the trial. But due to scepticism and lack of awareness, parents back off later. We have got only 11 children at present, who have taken the first shot of the vaccine,” said Dr Ramesh Bharmal, dean, Nair hospital. The hospital has not recorded any severe side effects of the drug among the children. Fifty percent of the volunteers will be provided with a placebo.
ZyCoV-D is a plasmid DNA vaccine, a first-of-its-kind vaccine that uses a genetically engineered DNA molecule known as a plasmid which is coded to generate spike protein of the SarsCoV-2,
the virus that causes Covid-19. It elicits an immune response against it and develops antibodies. On July 1, in a statement, the manufacturer declared that they have recorded 66.6% ‘primary efficacy’ in their ‘interim analysis’.
A total of three doses will be given to the volunteers. After the first dose, the second and third doses will be given after a gap of 28 and 56 days, respectively. As per protocol, along with written consent, an audio-visual consent of parents of the children is also required for the trial.
With the intention of sensitising parents, the hospital has also started two helpline numbers — 022-23027205 and 23027204. Parents who want to enrol their children in the trial can call on these numbers and clear their doubts.
“Every day, we receive seven to 10 enquiries about the trial. Many also visit our hospital asking about the clinical trial, but eventually they don’t enrol their children,” said Dr Bharmal.