Is Covaxin safe for children? Here's what Bharat Biotech has to say

The company claimed that it has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required

PTIUpdated: Friday, June 17, 2022, 04:31 PM IST
article-image
Bharat Biotech's Covaxin vaccine | Wikimedia Commons

New Delhi: 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.

(To receive our E-paper on whatsapp daily, please click here. To receive it on Telegram, please click here. We permit sharing of the paper's PDF on WhatsApp and other social media platforms.)

RECENT STORIES

Bypoll elections: Body blow to AAP in Punjab, as SAD beats its candidate

Bypoll elections: Body blow to AAP in Punjab, as SAD beats its candidate

Teesta Setalvad remanded to police custody until July 1; Gujarat govt sets up SIT probe

Teesta Setalvad remanded to police custody until July 1; Gujarat govt sets up SIT probe

Rohit Sharma tests positive for Covid; isolated in team hotel

Rohit Sharma tests positive for Covid; isolated in team hotel

UP Bypolls: BJP shine in SP’s bastion in Rampur, BSP plays spoilsport for Akhilesh Yadav

UP Bypolls: BJP shine in SP’s bastion in Rampur, BSP plays spoilsport for Akhilesh Yadav

Maharashtra political crisis: Until rebel MLAs don't merge with another party, disqualification...

Maharashtra political crisis: Until rebel MLAs don't merge with another party, disqualification...