Bharat Biotech’s Covaxin gets emergency use approval for vaccinating kids against COVID19
Indigenously developed Covaxin has been given an emergency use approval for kids aged 2-18 years. Although the health ministry's Subject Expert Committee on COVID19 has given nod for vaccinating children with Covaxin, the World Health Organization is yet to approve the vaccine.
This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.
In a move that could soon result in children getting vaccinated against COVID19 in India, the Union Ministry of Health and Family Welfare has granted emergency use approval to Bharat Biotech’s Covaxin. The vaccine will now be used to inoculate kids and teens from two to 18 years of age.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. We now await further regulatory approvals from the CDSCO [Central Drugs Standard Control Organisation] prior to product launch and market availability of COVAXIN for Children,” reads the statement by Bharat Biotech.
Covaxin, which has proved to be about 78 per cent effective in clinical trials against the coronavirus, will be administered to kids and teens in two doses with a gap of 28 days between the first and the second dose.
Earlier this month, Drugs Control General of India (DCGI) had received Bharat Biotech’s data from its Phase II and III clinical trials which were conducted on children from the 2-18 age group.
During the trial, two doses of the Covaxin vaccine were administered to 525 children 28 days apart. Although the Subject Expert Committee on COVID19 has given nod, the World Health Organization (WHO) is yet to grant emergency use authorisation to Covaxin.
Recently, Zydus Cadila’s new DNA-based vaccine was given emergency use approval and can be given to adults and children aged 12 yea but it is yet to be made available in the market.
The Union Ministry of Health and Family Welfare also announced that Zydus Cadila’s COVID19 vaccine ‘ZyCoV-D’ will soon be introduced in India’s inoculation drive.
“Zydus Cadila vaccine has been given emergency use approval. In the short term it won’t come to the market. But it would come into the COVID vaccination programme. We are in conversation with the manufacturers about the pricing of the vaccine,” Union health secretary Rajesh Bhushan said during the media briefing on September 30.