NEW DELHI: Bharat Biotech International Ltd (BBIL) on Tuesday said its COVID-19 vaccine, Covaxin, has received emergency use approval in children 6-12 years of age in India.
Earlier approved for children 12-18 years of age, Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study in children 2-18 years of age, Bharat Biotech said in a statement.
The company said it conducted clinical trials in the paediatric population between June 2021 to September 2021 and results have shown robust safety, reactogenicity, and immunogenicity.
"The data readouts were submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received emergency use nod for children aged 12-18 from DCGI during December 2021," it added.
Bharat Biotech further said clinical trials in children documented seroconversion at 95-98 per cent, four weeks after the second dose, indicating superior antibody responses in children when compared to adults.
Commenting on the development, Bharat Biotech Chairman and Managing Director Krishna Ella 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 Covaxn has now proven data for safety and immunogenicity in children. We have achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children."
The company said fresh stocks of Covaxin are available and ready for supplies.
It has readily available more than 5 crore doses of Covaxin in vials, and more than 20 crore doses as a drug substance.
"Additional production capacity is also available to meet product demand," it added.
Earlier this month, Bharat Biotech had announced that it was temporarily slowing down the production of Covaxin across its manufacturing units, for facility optimisation as it has already completed its supply obligations to procurement agencies and foresees a decrease in demand.
The World Health Organization (WHO) had also confirmed the suspension of the supply of Covaxin through UN procurement agencies and recommended countries that received the vaccine take action as appropriate.
WHO had said the suspension was in response to the outcome of the WHO post-Emergency Use Listing (EUL) inspection and the need to conduct process and facility upgrades to address identified GMP deficiencies.
The company after the WHO post-Emergency Use Listing (EUL) inspection, said it was working on further improvements and upgrades to ensure that the production of Covaxin continues to meet ever-increasing global regulatory requirements.