Pune-based SII likely conduct trials for those under the age of 18
Serum Institute of India (SII), which is a front-runner for providing Covid-19 vaccine to India, might begin a separate trial study on those aged below 18 years to understand the safety and efficacy of Covishield vaccine against Sars-Cov-2 virus which causes the Covid-19 infection.
During an online interaction with journalists Adar Poonawalla, chief executive officer (CEO), SII, said, that the institute might consider initiating separate trials for children which will start only after a few months. “A separate trial study among children and adolescents would likely delay the vaccination process for this age group even after the vaccine is approved for administering among adults,” he said.
The safety and efficacy of the vaccine are being studied only in the adult age group.
He said, “Not now, but maybe in future we are looking at doing a trial for those under 18 years. We have to do that after the safety and efficacy of the vaccine is proven on adults which is the same for all candidates, be it the US or UK.”
Poonawalla said that the vaccine has proven its efficacy. He said, “As we found that there were zero hospitalizations among those who got infected, as in there were no severe symptoms. We also found that the sterilizing immunity as in the infection rate of a vaccinated person who got infected was reduced by 60 per cent which is an indicator of a good vaccine especially against Covid-19 which is highly infective.”
Experts stress on the need for a separate trial study for those aged under 18 until which the vaccination for children should not be carried out. Dr Subhash Salunkhe, who chairs the Maharashtra Communicable Diseases Prevention and Control Technical Committee, said, “The current age group for which the phase two and three trial studies are going on does not include either those below 18 or even those above 60 years of age. There are two schools of thought where one might say that no separate trial is necessary while another might say that it is necessary to understand its efficacy, whether vaccinated kids would act as a transmitter and also if the vaccine would work the same way as it works for adults when it comes to hospitalization or severity of symptoms.”
“Currently they do not have any data for that age group and such data needs to come out first which needs to be peer-reviewed by the scientific community before any solid conclusions can be made until then such statements are only superficial,” he said.
Dr Tushar Parikh, consultant neonatologist and paediatrician, Motherhood Hospital, said, “It is always prudent to confirm vaccine efficacy and safety in children separately as their immune system is developing and it may not respond in the same way. Side effect profiles may be different. So once the safety and efficacy are confirmed in adults I hope that there will be trials in children to confirm safety and efficacy.”
“Fortunately children are less severely affected by Covid -19 so priority is developing adult vaccines. Normally it takes ten years for a vaccine development trial study to be completed. However, in this scenario things are happening at record break timings as multiple processes are being conducted simultaneously and so it would be difficult to say as to how much delay would this cause,” he said.