JOIN USCovid-19: Covaxin clinical trials in children to begin in 10-12 days
The first Indian trial of a homegrown Covid-19 vaccine on children is set to start in the next 10-12 days, a top health official said on Tuesday, amidst a global concern that the next wave of the pandemic may hit them in a big way.
"The Covaxin trial on children would start in the next 10-12 days,” V K Paul, NITI Aayog member and chairman of the government task force on Covid-19 said here on Tuesday.
Last week, the Drugs Controller General of India (DCGI) accorded permission to Hyderabad-based Bharat Biotech to conduct the phase II/III clinical trial of Covaxin on 525 healthy volunteers in the age group two to 18 years.
During the trial, the vaccine will be given by intramuscular route in two doses at a gap of 28 days after which they would be kept under observation to see how many of them develop infections.
The last ICMR sero-survey carried out in December showed a similar level of sero-positivity in adults and children. The sero-positivity was 21.4 per cent among adults, more than 18 years of age, whereas in children aged 10-17 years, the sero-positivity was 25.3 per cent.
While most of the Covid-19 affected children are asymptomatic, Paul said the children should be encouraged to wear masks and follow the social distancing norms just like the adults.
On Saturday, the USA's Centers for Disease Control and Prevention recommended that all those 12 years and older should get a Covid-19 vaccination to help protect against the infection as widespread vaccination was a critical tool to help stop the pandemic. The CDC recommended the Pfizer-BioNTech vaccine, which was shown to protect children from the SARS-CoV-2 virus.
Paul also pointed out that the government was keeping a close watch on cases where people develop serious Covid-19 disease even after taking two doses of the vaccines.