Bharat Biotech International Ltd on Friday stated its COVID-19 vaccine Covaxin has confirmed to be secure, well-tolerated and extremely immunogenic in youngsters and adolescents of 2-18 years age group in section II/III research. The firm performed section II/III, open-label, and multicentre research to judge the protection, reactogenicity and immunogenicity of Covaxin in wholesome youngsters and adolescents within the 2-18 years of age group between June 2021 to September 2021, Bharat Biotech International Ltd (BBIL) stated in an announcement.
“The study has been accepted and published in Lancet Infectious diseases, peer-reviewed high impact factor journal,” the corporate stated.
The scientific trial performed within the pediatric inhabitants has proven security, much less reactogenic, and strong immunogenicity. The knowledge was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021, and obtained a nod for emergency use in youngsters aged 6-18 years, it added.
“Safety of the vaccine is important for kids and we’re glad to share that Covaxin has now confirmed knowledge for security and immunogenicity in youngsters.
“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 stated.
Bharat Biotech stated within the research, no critical hostile occasion was reported. A complete of 374 hostile occasions had been reported, and nearly all of hostile occasions had been delicate in nature and resolved inside at some point. Pain on the injection web site was essentially the most generally reported hostile occasion.
The firm claimed that it has a stockpile of greater than 50 million doses of Covaxin able to be distributed as required.
Source: www.financialexpress.com”