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BYL Nair Hospital starts clinical trial of Zydus Cadila’s Covid vax on those aged between 12 and 17
BYL Nair Hospital in Mumbai Central has become the first civic-run hospital to start the phase 3 clinical trial of indigenous vaccine ZyCoV-D on children in the city
BYL Nair Hospital in Mumbai Central has become the first civic-run hospital to start the phase 3 clinical trial of indigenous vaccine ZyCoV-D on children in the city. A total of 50 children between the age 12 and 17 will be enrolled for the trial. Half of the volunteers will be given placebo, a false replica of the vaccine.
Ahmedabad-based drug maker Zydus Cadila has manufactured ZyCoV-D — a plasmid DNA vaccine, which is the first-of-its-kind that uses a genetically engineered DNA molecule known as a plasmid which is coded to generate spike protein of Sars-CoV-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.
The primary objective of the clinical trial reads, “To demonstrate the efficiency of ZyCoV-D in the prevention of virologically-confirmed symptomatic Covid-19 cases as compared to placebo.”
The enrolment of volunteers has begun at the hospital. “The volunteers have to be healthy, without severe comorbidities. We are looking to select children with educated parents as they will have to maintain a diary of daily health updates and submit to the hospital for consultation,” said a senior doctor.
Along with written consent, audio-visual consent will also be taken from the parents of the children. “The parents will also have to agree that during the course of the trial, they would not get their children vaccinated,” said the doctor.
As part of the trial, three doses will be administered to the volunteers. After the first dose, the second and third dose will be given after a gap of 28 and 56 days.
“In the second wave, we have seen that a large number of children contracted Covid-19 infection. If this vaccine proves to be effective among children then it will be a great relief for parents, since there is no vaccine available in the market for children as of yet,” said Dr Ramesh Bharmal, dean of the hospital.
“As seen in BMC’s sero survey, almost 50% surveyed children had antibodies, which indicates that a large number of children had contracted Covid-19 but remained undiagnosed. Hence, there is a need for a vaccine for children especially when cities are planning to open schools. This can save children from not only getting infected and but will also prevent the infection from being transmitted among the elderly population in their families,” said Dr Bela Verma, paediatrician from Sir JJ Hospital.
ZyCoV-D is an intradermal vaccine, applied using a needle-free injector. Zydus claims that 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,” reads the statement.
The vaccine can be stored at a temperature between two and eight degrees Celsius, and has shown good stability at 25 degrees Celsius for at least three months.
The manufacturer has recently applied to the Drug Controller General of India (DCGI) for emergency use authorisation (EUA) of the vaccine. Once Zydus receives approval, ZyCoV-D would become the fifth anti-Covid vaccine authorised for use in India, after Covishield, indigenous Covaxin, Sputnik V and Moderna.
