
“We have got a clearance from our internal ethics committee for the trial. This is part of a pan-India study on 1,500 children. In our institute we will be engaging 100 volunteers,” said ICH professor, Jaydeep Choudhury, who would be co-investigating the trial with associate professor, Monjori Mitra, the principal investigator.
After Covaxin, ZyCov-D is the second indigenous vaccine to be tried on children. While the trial on Covaxin is being taken up by some select institutes like AIIMS Patna and Delhi, ICH will be the first to take up the trial for children’s vaccination in Bengal.
The institute has already begun the process of recruiting volunteers. A local school has even approached the institute, volunteering help in case they could mobilise volunteers among their students. The screening process will start soon. The vaccine vials are expected to arrive in the Kolkata hospital in a couple of days.
“With the hypothesis of a third wave and possibility of more children being hit, it is important for them to be vaccinated. If the vaccine proves its efficacy, this can offer a ray of hope and protection to children,” said ICH director, Apurba Ghosh.
A DNA plasmid vaccine ZyCov-D uses genetic code in the virus aiming at stimulating immune response. The vaccine is expected to help the body develop specific antibodies for defence against the virus. “In a pandemic situation one cannot afford to wait for the complete clinical evaluation of a vaccine’s efficacy. If the trial for this vaccine can generate immunogenicity in terms of neutralising antibody titre and safety data proving its efficacy, it is likely to be clinically effective as well. And if it gets EUA (emergency use authorisation) before the third wave hits, it will be used for the paediatric population,” said senior clinical trial specialist, Santanu Tripathi, former head of clinical and experimental pharmacology at School of Tropical Medicine.
All the three vaccines currently being administered in India —Covishield, Covaxin and Sputnik V — are also rolled out under EUA.
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