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Covaxin is safe, well tolerated in the age group of 2-18 years, and Barrat Biotech cites a lancet study-The New Indian Express

Covaxin is safe, well tolerated in the age group of 2-18 years, and Barrat Biotech cites a lancet study-The New Indian Express

 


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Bharat Biotech International Limited (BBIL) announced on Friday that its COVID-19 vaccine, covaxin, has proven safe, tolerable and immunogenic in Phase II / III pediatrics. did.

According to a press release from the vaccine manufacturer, the study was accepted and published for lancet infections, according to a peer-reviewed Impact Factor Journal.

Bharat Biotech conducts Phase II / III, open-label, multicenter trials to evaluate cobacxin safety, responsiveness, and immunogenicity in healthy children and adolescents aged 2-18 years did.

Clinical trials conducted in pediatric populations between June 2021 and September 2021 have shown low safety, low responsiveness, and high immunogenicity.

The data was submitted to the Central Drugs Standard Control Organization (CDSCO) in October 2021 and approved for emergency use in children ages 6-18.

Read again | India added 12,847 new Covid cases and 14 deaths.More than 4800 active cases

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said:

We have now developed a safe and effective COVID-19 vaccine for adults and children, with primary and boost immunization, and achieved our goal of making covaxin a universal vaccine.

“Based on data from more than 50 million doses given to children in India, it proved to be a very safe vaccine.

Vaccines are an excellent preventive tool, and the power of vaccines is only available when used “prophylactically”, he added.

No serious adverse events have been reported in this study. A total of 374 adverse events were reported, with the majority of the adverse events being mild in nature and resolved within a day. Injection site pain was the most commonly reported adverse event, Release said.

(There is input from the agency)

Sources

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2/ https://www.newindianexpress.com/nation/2022/jun/17/covaxin-safe-well-tolerated-in-2-18-years-age-group-bharat-biotech-cites-lancet-study-2466733.html

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