Has Drug Controller General allowed Bharat Biotech to Conduct Clinical Trials of its Vaccine on Children Above 12?

News reports suggest that the country’s central drug regulator, Drug Controller General of India (DGCI) has given permission to the pharmaceutical company Bharat Biotech to conduct a clinical trial of its vaccine on children above 12 years of age.

This is for the first time that the vaccine trial is happening for children below the age of 18. Earlier, all the volunteers of the trial were above 18 years of age.

Till the time this report was published, no government confirmation was available anywhere. Neither the company nor the DCGI confirmed this report.

The DCGI on January 3 given permission for vaccines developed by two companies – SII and Bharat Biotech – to be administered to people after their clinical trial data shows that both the vaccines are effective and safe to use.

The Union Health Minister Dr. Harsh Vardhan had clarified on January 3 that the Emergency Use Authorisation (EUA) for COVAXIN developed by Bharat Biotech is differently conditional, ie, in clinical trial mode.

Dr. Harsh Vardhan said on Twitter, “For those spreading rumours let it be known that EUA for COVAXIN is differently conditional – in clinical trial mode.”

He added, “EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode. All COVAXIN recipients to be tracked, monitored as if they’re in trial.”

For those spreading rumours let it be known that EUA for COVAXIN is differently conditional – in clinical trial mode

EUA for COVAXIN is different from COVISHIELD because its use will be in clinical trial mode.
All COVAXIN recipients to be tracked,monitored as if they’re in trial pic.twitter.com/1N8LGnhC3w

— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021

According to him, “COVAXIN approval is ‘Monitored Approval’ with strict follow-up & rolling review.”

He also said that the DCGI approval ensures India has an additional vaccine shield in its arsenal esp against potential mutant strains in a dynamic pandemic situation - A strategic decision for our vaccine security.”