Bharat Biotech submits clinical trial data for paediatric vaccine to DCGI

The wait for a paediatric Covid-19 vaccine for children over two years may soon be over if India’s drug regulator decides to approve Bharat Biotech’s Covaxin for use in children.

The Hyderabad based vaccine maker has already submitted data from phase-2 and 3 clinical trials to the Drugs Controller General of India (DCGI) for review.

The company confirmed the development.

“Covaxin Clinical trials data of 2-18 years age group has been submitted to the Central Drugs Standard Control Organisation (CDSCO),” the company said.

The vaccine maker added that Covaxin is the first Covid-19 vaccine to be tested in the 2-6-year age group. “This is feasible due to the safety of the manufacturing platform and empirical evidence from phase I, II, III clinical trials in adults,” it said.

Bharat Biotech had completed phase-2 and 3 clinical trials on children in September, and the company had indicated that it was working on analyzing the data generated from the trials.

Covaxin production ramp-up has been a matter of concern. Recently, however, the company has indicated that it would make 55 million doses in October, up from the 35 million last month.

Paediatric vaccines are also a sizable market. A Mumbai-based analyst noted, “It is estimated that 350-400 million people in India are below 18-years of age. Considering two doses Covid vaccine regimen, this would translate into 700-800 million doses potential demand easily.”

According to a Unesco estimate, around 321 million Indian children were asked to stay home when the lockdown began at the end of March last year.

Already Zydus Cadila’s DNA vaccine has been approved for children aged 12 years and above. It is yet to be available in the market.

Serum Institute of India is conducting trials on children for the Novavax vaccine (named Covovax in India) and has recently started trials on seven to eleven year old children. It had started trials 12 years and above earlier. Covovax would also be eventually tested on children above two years.