Bharat Biotech likely to begin Covaxin trial on children and youngsters by early March

Mangalore Today News Network

New Delhi, Feb 08, 2021:     At a time when the vaccination drive in India has entered phase two, Bharat Biotech is awaiting a nod from the government to conduct vaccine trials in the paediatric population as well. This has suddenly started the debate whether this is the right time to conduct these trials.

 

Sources associated with the research programme on this subject told India Today TV that the nod from DCGI (Drugs Controller General of India) office is expected in a week’s time.

“The big announcement could come in less than a week’s time. We are still awaiting approval of the government. And then the big announcement could be made,” said a person in the knowhow of the development.

This person also added that the efficacy of the drug had already been proved in children between 12-18 years and trials would be focused on kids below 12 years.

“Five-Eighteen is the schooling age and hence the parents too will feel confident once the trial is successful. Plus, the government needs proof and then the regular classes could resume without any anxiety as well. The various hospitals for the trails have been suggested to the government and the final call has to be taken by the government.”

India Today TV also got in touch with medical experts to get their opinions on the sensitive subject.

Doctor Lancelot Pinto, Consultant Pulmonologist, P.D Hinduja Hospital & MRC, said, “Children have been almost unaffected by Covid. A vaccine that will be offered to children will need to have almost zero serious adverse effects to be able to justify its use in a population that’s vulnerable (does not consent themselves) and extremely low-risk from the disease perspective.”

“Testing the vaccine on children will need to be conducted with these facts made explicitly clear to the parents of the children who consent. The strongest reason to vaccinate children is to protect the elderly from transmission, but this cannot be justified if it means exposing healthy kids to even the rarest serious adverse effects,” he added.

Doctor Samir Sheikh, Consultant Neonatology, Wockhardt Hospital, said, “Safety and efficacy for the paediatric population for vaccine trial are generally extrapolated from adult data. If adult data is encouraging, definitely trial on children should begin.”

“Approval for trial is pending since Covaxin from Bharat biotech is still in phase 3 trial for adults. It’s a good move because the vaccine needs to cover the paediatric population at some point in time. Without trials, it’s not possible to know vaccine’s safety and efficacy,” Sheikh added.

Doctor Sanjay Nagarkar, general physician, Apollo Spectra Hospital in Pune, said it will essential to first see to it that safety and warned that it should not be assumed that it will work on children because it works on adults.

“The vaccine was tested in the adults, but now the vaccine trials will be initiated on the kids. Hence, it is essential to first see to it that safety is first established in adults. Do not assume that if the vaccine works in adults then it will produce the same results in children without taking trials in the paediatric population. Moreover, the vaccine dose administered to the adults and the children will be different. But it is necessary for children to get vaccinated, as children can spread the infection into their families and outside. So, immunisation is important,” he said.

Courtesy:India Today