DCGI allows Bharat Biotech to conduct vaccine trials on children above 12

Bharat Biotech's coronavirus vaccine 'Covaxin', which received emergency approval only in "clinical trial mode", has been approved for conducting trials on children above the age of 12 years by the Drugs Controller General of India (DCGI).

The vaccine has already been used on children above 12 in phase 1 and 2 trials and has been found safe. The Hyderabad-based firm is conducting Phase III trials. The vaccine is yet to complete late-stage human clinical trials in India.

Oxford-AstraZeneca coronavirus vaccine 'Covishield', manufactured by Pune-based Serum Institute of India (SII) has been approved for those above the age of 18.

The DCGI on Sunday gave its final approval to the Oxford-AstraZeneca and Bharat Biotech coronavirus vaccines for restricted use in an emergency situation, giving the country its first two shots for immunising its vast population in the coming weeks. Both the vaccines will be administered in two doses, the DCGi said.

The approval by the DCGI was given on the basis of recommendations submitted by a coronavirus subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Union Health Minister Dr Harsh Vardhan had clarified yesterday that emergency approval for Covaxin is different from the one given for Covishield because Covaxin's use will be in clinical trial mode, which means, all its recipients will be tracked and monitored as if they are participating in a trial.

Meanwhile, the BJP hit out at the Congress after some of its leaders questioned the approval process for Covaxin, with party president JP Nadda alleging that whenever India achieves something commendable the opposition comes up with "wild theories" to "ridicule" the accomplishments.

Some Congress leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, raised serious concerns over the grant of approval to Covaxin, saying it is "premature" and can prove dangerous.

Health Minister Vardhan said Bharat Biotech's vaccine is more likely to work against newer variants of coronavirus, including the UK variant, and asked politicians not to "discredit" the approval protocol.

ICMR Director General Balram Bhargava also said Covaxin is based on an inactivated whole virus, having the potential to target mutated coronavirus strains including the UK variant, which was a major ground for giving it a conditional nod.

Later on Sunday evening, the DCGI gave licensing permission to Bharat Biotech to manufacture Covaxin. The drug regulator also asked Bharat Biotech to submit its safety, efficacy, and immunogenicity data from the ongoing phase I, II, and Ill clinical trials till the completion of trials.