New Delhi, June 17: Bharat Biotech International Ltd on Friday said its COVID-19 vaccine Covaxin has proven to be safe, well-tolerated and highly immunogenic in children and adolescents of 2-18 years age group in phase II/III study.
The company conducted phase II/III, open-label, and multicentre study to evaluate the safety, reactogenicity and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 years of age group between June 2021 to September 2021, Bharat Biotech International Ltd (BBIL) said in a statement.
“The study has been accepted and published in Lancet Infectious diseases, peer-reviewed high impact factor journal,” the company said.
The clinical trial conducted in the pediatric population has shown safety, less reactogenic, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021, and received a nod for emergency use in children aged 6-18 years, it added.
“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.
“We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children for primary immunisation and booster doses, making Covaxin a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India,” Bharat Biotech Chairman and MD Krishna Ella said.
Bharat Biotech said in the study, no serious adverse event was reported. A total of 374 adverse events were reported, and the majority of adverse events were mild in nature and resolved within one day. Pain at the injection site was the most commonly reported adverse event.
The company claimed that it has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required.
Meanwhile, India reported a single-day rise of 12,847 coronavirus infections, taking the tally of cases to 4,32,70,577, while active cases increased to 63,063, according to the Union Health Ministry data issued on Friday.
The data updated at 8 am also recorded 14 fresh fatalities, pushing the overall death figure to 5,24,817.
The active cases now constitute 0.15 per cent of the total infections, while the country’s COVID-19 recovery rate was recorded at 98.64 per cent, the health ministry said. The case fatality rate was 1.21 per cent.
An increase of 4,848 cases has been recorded in the active COVID-19 caseload in a span of 24 hours.
The daily positivity rate was recorded at 2.47 per cent and the weekly positivity rate was 2.41 per cent, according to the health ministry.
The number of people who have recovered from the disease rose to 4,26,82,697.
A total of 5,24,817 deaths have been reported so far in the country including 1,47,880 from Maharashtra, 69,853 from Kerala, 40,110 from Karnataka, 38,026 from Tamil Nadu, 26,225 from Delhi, 23,525 from Uttar Pradesh and 21,207 from West Bengal.
Of the 14 new fatalities, eight are from Kerala, three from Maharashtra, two from Delhi and one from Karnataka. (PTI)
