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June 20, 2022

Bharat’s Phase II/III Covaxin trial shows safety in children

Vaccine-linked cases of AEFIs such as myocarditis, blood clots and pericarditis were not found with Covaxin.

Bharat Biotech International has reported that its whole-virion inactivated Covid-19 vaccine candidate, BBV152 (Covaxin), was found to be safe, well-tolerated and immunogenic in paediatric participants in Phase II/III clinical trial.

The multicentre, open-label trial analysed the safety, reactogenicity and immunogenicity of the vaccine in healthy children and adolescents aged two to 18 years.

The neutralising antibodies found in children were on an average 1.7 times greater than those seen in adults.

Findings from the trial, which was carried out between June and September last year in the paediatric population, were submitted to the Central Drugs Standard Control Organisation (CDSCO) in October last year and obtained approval for emergency use in children of the age six to 18 years.

Furthermore, no serious adverse event was found in the trial while 374 adverse events were reported.

Most of the adverse events were observed to be mild and resolved within a day.

Vaccine-linked cases of AEFIs such as myocarditis, blood clots and pericarditis were not found with Covaxin.

Covaxin is formulated in a way that the same dose can be given to adults and children for primary vaccination and as a booster, making it a universal vaccine.

Bharat Biotech chairman and managing director Dr Krishna Ella said: “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.”

The company currently has a stockpile of over 50 million doses of the vaccine ready to be supplied as needed.

In September 2020, Bharat Biotech received regulatory approval to advance Covaxin into Phase II trials.

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