Covaxin receives DCGI approval for use in children from 12 to 18 years

Biotechnology company Bharat Biotech’s Covid-19 vaccine Covaxin has received the Drugs Controller General of India’s emergency use approval for use in children from 12 to 18 years of age, the company said on Saturday.

This is the second Covid-19 vaccine to have received emergency use authorisation from the DCGI for children. On August 20, pharmaceutical company Zydus Cadila’s needle-free vaccine ZyCoV-D had received the regulator’s approval for use in children from 12 to 18 years of age.

Bharat Biotech said on Saturday that Covaxin has been formulated in such a way that the same dosage can be administered to adults as well as children. It said that the vaccine has a “proven record for safety and efficacy in adults for the original variant [of Covid-19] and subsequent variants.

“We have documented excellent safety and immunogenicity data readouts in children,” Bharat Biotech said. “We look forward for Covaxin to provide similar levels of protection for adults and children alike.”

The indigenously-developed Covaxin has been used in India since India began its immunisation drive on January 16. The vaccine, along with Oxford-AstraZeneca’s Covishield, were the first Covid-19 vaccines to be approved in India.

The World Health Organization had on November 3 had granted emergency use listing for Covaxin. Emergency use listing is a procedure by the global health body to approve vaccines and other products for use during public health emergencies.

It had taken more than three months for Covaxin to get the WHO’s clearance.

On Saturday, Prime Minister Narendra Modi announced that India’s vaccination programme will be opened to children over the age of 15 from January 3. He made no mention of children below 15.

“The decision [to vaccinate children] will help in making India’s battle against the coronavirus stronger, and it will also ease the worries of the parents of the children going to schools and colleges,” the prime minister had said.