50 children aged between 12 and 17 years have been chosen for these trials and half of them will be given a placebo dosage.
In a bid to accentuate the country's vaccination program, phase 3 clinical trials of natively developed vaccine ZyCoV-D are being conducted on the kids in Mumbai. As per the latest developments, BYL Nair Hospital is the first civic-run centre to implement the phase-3 trial of Zydus Cadila manufactured vaccine on children in the city. Reportedly, 50 children aged between 12 and 17 years have been chosen for these trials and half of them will be given a placebo dosage.
Registration of healthy volunteers has begun at the medical centre
Drug company Zydus Cadila from Ahmedabad has manufactured this new vaccine which propels the production of spike proteins of the highly contagious virus. When it is introduced in the body, it kicks the immune response leading to the production of antibodies. As per reports, the manufacturer informed that the vaccine showed 66.6% efficacy in the provisional examinations.
As per reports, the registration of healthy volunteers has already started at the medical centre. According to an authority, children with educated parents are being prioritised so that a proper record of their health parameters can be maintained. Additionally, it has been stated that parents will have to promise that they will not get their children inoculated during the course of the trial. Further, reports state that parents are being asked to provide audiovisual consent besides the written declaration.
Injection-free administration to help in reducing the side effects
Under the trial process, the kids will be administered three doses of the vaccine. Reportedly, the second and third doses will be given, post a period of 28 and 56 days respectively. Notably, reports state that the serosurvey conducted in Mumbai showed that around 50% of kids in the sample group had pre-developed antibodies. If a vaccine for kids is approved, it would not only help the kids but also save the elderly population from transmitted infections.
Interestingly, this vaccine is given through a needle-free injector and reports state that this would help in mitigating the side effects. Further, it has been reported that the vaccine can be modified to fight against different mutations of the virus due to the plug and play technology. While the jab can be preserved between 2 and 8 degrees celsius, it is found to be stable for 3 months at 25 degrees.
As per reports, the production company Zydus is now seeking approval from the Drugs Controller General of India. If the jab gets sanctioned, it will be fifth vaccine to be approve in India.