Wednesday, 19 May 2021 | PNS | New Delhi
Hyderabad-based Bharat Biotech will start its Covid-19 vaccine Covaxin’s Phase II and III clinical trials on 2 to 18 years age group within the next 10-12 days.
India’s drug regulator, the Drugs Controller General of India (DCGI), has already given Bharat Biotech the permission to conduct the clinical trials on children in the age group. It will be the first such coronavirus vaccine to be tested on minors in the country.
The development comes against the backdrop of the fear that in the third wave of Covid-19, which is expected in the next few months, it will be children who will be the most affected due to the infection.
“Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II and III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days,” Dr VK Paul, Member-Health, Niti Aayog said at a press conference on Tuesday here.
Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. The trial will be conducted on 525 healthy volunteers.
Covaxin, which has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing Covid-19 vaccination drive.
The Centre said it has so far provided, both free of cost & via direct State procurement, more than 20.78 cr vaccine doses (20,78,04,890) to States/UTs. Of this, total consumption, including wastages is 18,83,47,432 doses (as per data available at 8 am on Tuesday, it stated.
Experts in various cities like Bengaluru said they have already started reporting increased numbers of child cases suffering with Covid-19.
Between March 9 and September 25, when the first wave peaked, there were 19,378 cases among children aged up to 10 as per last year’s data available from Karnataka.
During the first wave, not many children were exposed to the virus, since the majority of them stayed indoors until it peaked. However, this year many children have got infected by the novel coronavirus, said health experts.
They said a majority of the children with Covid-19 are asymptomatic or have mild symptoms, and parents chose to ignore it, believing that they are not infected by the virus. “There are instances where parents have Covid-19, but they still choose to ignore mild symptoms in children. There is a lot of denial and stigma about getting tested, especially when it comes to children,” said a doctor.
