NEW DELHI: Amidst a spike in Covid-19 cases in the country, the Drugs Controller General of India (DCGI) on Tuesday approved three coronavirus vaccines for children for a restricted emergency use.
The DGCI gave restricted emergency use authorisation for Biological E’s Covid-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotech’s Covaxin for children in the age group of six to 12 years.
The national drug regulator has also granted permission to Cadila for its ZyCoV-D as an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged 12 and above. With this approval, this vaccine will now be given on day 0 and day 28. Earlier, ZyCoV-D had been approved in a three-dose regimen on day 0, day 28 and day 56.
The new approvals were tweeted by Union Health Minister Dr Mansukh Mandaviya, who said that India's fight against Covid has become more robust.
The announcement came as Prime Minister Narendra Modi is scheduled to hold a virtual meeting with chief ministers on Wednesday to discuss the recent spike in cases. In the last fortnight, many school-going children tested positive for Covid – mainly in Delhi and NCR region.
At the moment, Bharat Biotech’s inactivated whole virion vaccine is being administered in children aged 15-18 years, and Biological E’s protein subunit vaccine in children aged 12 -15 years under the national Covid-19 immunisation programme.
The vaccine restricted emergency use approval by the DCGI followed recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO).
Dr Krishna Ella, chairman and managing director of Bharat Biotech, said, “We have established Covaxin as a universal vaccine for adults and children. Safety of the vaccine is critical for children, and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children.”
The Hyderabad-based company, whose Covaxin supply through UN agencies has been suspended by the World Health Organisation (WHO) after an inspection flagged issues relating to manufacturing, said in a statement that “no serious adverse event was reported and the vaccine exhibits robust immune responses in children with two doses and six months follow up.”
Dr Sharvil Patel, MD, Zydus Lifesciences, said the approval would increase the compliance of the vaccine and reduce the overall time required for vaccination to improve immunity against the virus.
Covaxin, which is being used in the government mass immunisation programme, was granted Emergency Use Listing (EUL) by the DCGI for the 12 to 18 years age group on December 24.
India began vaccinating children aged 12-14 on March 16. So far, 2.70 crore children have been vaccinated.