Covid vaccine for kids: Clinical trial at Mumbai hospital hits roadblock
The phase-3 clinical trial of indigenous vaccine ZyCoV-D among children at the civic-run BYL Nair Hospital has hit a roadblock as parents are not permitting their kids to participate in it. Though the trial needs 50 children between the age group of 12 and 17 years, only five children have enrolled for it so far.
An Ahmedabad-based drug maker— Zydus Cadila — has manufactured ZyCoV-D, the second indigenous vaccine after Covaxin. It 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 Sars-Cov-2 virus. It elicits an immune response against the virus and develops antibodies.
In a statement on July 1, the manufacturer declared that they have recorded 66.6% ‘primary efficacy’ in their ‘interim analysis.’ In the second week of July, Nair Hospital became the first hospital in Mumbai to start the clinical trial of the vaccine among children. As per officials, initially they received over 40 queries from parents who wanted to enrol their children for their trial. However, eventually they all backed out “Due to scepticism and lack of awareness, parents make enquires about the clinical trial but eventually they don’t enrol their children into it. We have got only five children at present, who have taken the first shot of the vaccine,” said Dr Ramesh Bharmal, dean of the Nair Hospital.
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 the parents of the children is also required for the trial.
Officials said this tedious process often discourages parents from participating in the trial. “Earlier, we have conducted clinical trials on the Oxford-AstraZeneca’s Covishield where we just had to take a written consent. But in this ZyCoV-D trial, we have to record a 45-minute audio-visual consent of the parents where we read out a long list of guidelines and questionnaires to the parents on camera. This often confuses and scares parents who later opt out of the trial,” said a doctor from the pathology department of the hospital.
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. The hospital staff is also counselling parents of in-house patients for participating in the trial. But the response is still cold. “As we have seen in the second wave and in the latest sero survey, many children contracted infection. As there is no vaccine for children so far, parents should be more forthcoming in the trial of ZyCoV-D. Until the trials are completed, the authorities can’t roll it out for children,” said Dr Bharmal.
ZyCoV-D is also an intradermal vaccine, applied using a ‘needle-free injector’. Zydus claims the needle-free system can lead to a significant reduction in side effects.
“The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with Covid-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring,” read an official statement of Zydus.
It can be stored at 2-8 ° C and has shown good stability at temperatures of 25 °C for at least three months. Recently, the manufacturer applied to the Drug Controller General of India (DCGI) for emergency use authorization (EUA) of the vaccine.