The Drugs Controller General of India has granted permission to Bharat Biotech to conduct clinical trials of Covaxin on children in the 2-18 age group, according to an official release.
Bharat Biotech had submitted the proposal of conducting trials on children earlier this year. An expert committee that looked into the matter asked Bharat Biotech in February to submit a revised clinical trial protocol.
These will be the first vaccine trials to be conducted on children in India.
Rakesh P Kanyadi, director at Anglo-French Drugs and Industries Ltd, told The Observer: “Even the UNICEF said that the second wave can impact children. As much as it is important to vaccinate the elderly, vaccinating the younger population is also important and this is a step towards it.”
As part of the trial, the vaccine will be given to 525 healthy volunteers in two doses. There will be a 28-day gap between the two doses.
“We need to also look at genome sequencing. There isn’t enough research happening. Genome sequencing also helps in fighting the pandemic,” Kanyadi said.
The US gave the green signal this week for a Pfizer vaccine to be used in the age group 12 to 15. Canada too has approved the Pfizer vaccine for children as young as 12.
Experts say rising Covid-19 cases in India are worrisome, and vaccinating all is one of the best solutions to control the pandemic.